Combining Fish Oil and Exercise to Improve Obesity-associated Inflammation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas Tech University
- Enrollment
- 129
- Locations
- 2
- Primary Endpoint
- Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks
Study Overview
Brief Summary
The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.
Detailed Description
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative to understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk. These studies will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
The first aim of this study will focus on determining the combined effects of n-3 PUFA and HIIT on improving metabolic risks such as obesity-related markers of inflammation, dyslipidemia, and insulin resistance.
The investigators will test the hypothesis that n-3 PUFA, in addition to HIIT, will have beneficial effects on energy utilization, as well as obesity-related markers of inflammation, dyslipidemia and insulin resistance.
Aim 2.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition Aim 2.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity Aim 2.3: Investigate influence of n-3 PUFA and HIIT on energy utilization/ markers of insulin resistance
The second aim is to determine the combined effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and high-intensity interval training (HIIT) on improving gut dysbiosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-65 years old
- •Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
- •Elevated Triglycerides (>150 mg/dL)
- •Prediabetes (fasting blood glucose 100 to 125 mg/dl)
Exclusion Criteria
- •Diagnosed with Diabetes or liver disease.
- •Taking BP or diabetes medications.
- •Received antibiotics medications in the last 6 months.
- •Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
- •Currently following a formal/ structured weight loss program.
- •Currently taking fish oil.
- •Do not have access to smart phone/ computer with internet access.
- •Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
- •Feeling uncomfortable riding bike for 30 minutes.
- •Claustrophobic or unable to stay under the hood for metabolic testing.
Outcomes
Primary Outcomes
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Body weight at 10 weeks
Time Frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Post-Supplementation in Body weight at 8 weeks
Time Frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks
Time Frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Post-Intervention in Body weight at 10 weeks
Time Frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks
Time Frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time Frame: Post-intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 8 weeks
Time Frame: Post-Intervention at week 8
Triglycerides (mg/dL).
Mean Change from Baseline in total/HDL cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 8 weeks
Time Frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks
Time Frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks
Time Frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Total Cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Low-density lipoprotein (LDL)(mg/dL)
Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Total/HDL cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Triglycerides at 10 weeks
Time Frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Baseline in Insulin at 10 weeks
Time Frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Baseline in Fasting blood glucose at 10 weeks
Time Frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks
Time Frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks
Time Frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
Time Frame: Post-Intervention at week 8
Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
Mean Change from Baseline in Insulin at 8 weeks
Time Frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Baseline in Body Weight at 8 weeks
Time Frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Baseline in Fasting blood glucose at 4 weeks
Time Frame: Post-supplementation at week 4
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Insulin at 4 weeks
Time Frame: Post-supplementation at week 4
Insulin (μU/mL)
Mean Change from Baseline in Total Body Fat Percentage at 4 weeks
Time Frame: Post-Supplementation at week 4
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in Body Weight at 4 weeks
Time Frame: Post-Supplementation at week 4
Body weight (kilograms)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks
Time Frame: Post-Supplementation at week 4
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks
Time Frame: Post-Supplementation at week 4
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks
Time Frame: Post-Supplementation at week 4
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks
Time Frame: Post-Supplementation at week 4
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks
Time Frame: Post-Supplementation at week 4
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Tumor necrosis factor at 4 weeks
Time Frame: Post-Supplementation at week 4
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 4 weeks
Time Frame: Post-Supplementation at week 4
Total cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks
Time Frame: Post-Supplementation at week 4
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 4 weeks
Time Frame: Post-Supplementation at week 4
Triglycerides (mg/dL).
Mean Change from Baseline in Total/HDL cholesterol at 4 weeks
Time Frame: Post-Supplementation at week 4
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
Time Frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
Time Frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Total Body Fat Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks
Time Frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks
Time Frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks
Time Frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Supplementation in Triglycerides at 8 weeks
Time Frame: Post-Intervention at week 8
Triglycerides (mg/dL)
Mean Change from Post-Supplementation in Insulin at 8 weeks
Time Frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks
Time Frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks
Time Frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks
Time Frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Intervention in Total Cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Intervention in Triglycerides at 10 weeks
Time Frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Post-Intervention in Insulin at 10 weeks
Time Frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks
Time Frame: Post-Supplementation at week 4
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks
Time Frame: Post-Supplementation at week 4
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks
Time Frame: Post-Supplementation at week 4
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Tumor necrosis factor at 4 weeks
Time Frame: Post-Supplementation at week 4
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 4 weeks
Time Frame: Post-Supplementation at week 4
Total cholesterol (mg/dL)
Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks
Time Frame: Post-Supplementation at week 4
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks
Time Frame: Post-Supplementation at week 4
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time Frame: Post-intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 8 weeks
Time Frame: Post-Intervention at week 8
Triglycerides (mg/dL).
Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks
Time Frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks
Time Frame: Post-Supplementation at week 4
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Triglycerides at 4 weeks
Time Frame: Post-Supplementation at week 4
Triglycerides (mg/dL).
Mean Change from Baseline in Total/HDL cholesterol at 4 weeks
Time Frame: Post-Supplementation at week 4
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 4 weeks
Time Frame: Post-supplementation at week 4
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Insulin at 4 weeks
Time Frame: Post-supplementation at week 4
Insulin (μU/mL)
Mean Change from Baseline in Total Body Fat Percentage at 4 weeks
Time Frame: Post-Supplementation at week 4
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in total/HDL cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 8 weeks
Time Frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
Time Frame: Post-Intervention at week 8
Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
Mean Change from Baseline in Insulin at 8 weeks
Time Frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Baseline in Body Weight at 8 weeks
Time Frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Body Weight at 4 weeks
Time Frame: Post-Supplementation at week 4
Body weight (kilograms)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks
Time Frame: Post-Supplementation at week 4
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
Time Frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
Time Frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks
Time Frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks
Time Frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Supplementation in Body weight at 8 weeks
Time Frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks
Time Frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Total Cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Low-density lipoprotein (LDL)(mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Total/HDL cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Triglycerides at 10 weeks
Time Frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Baseline in Insulin at 10 weeks
Time Frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Baseline in Fasting blood glucose at 10 weeks
Time Frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Body weight at 10 weeks
Time Frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Baseline in Total Body Fat Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks
Time Frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks
Time Frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks
Time Frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks
Time Frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks
Time Frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks
Time Frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Supplementation in Triglycerides at 8 weeks
Time Frame: Post-Intervention at week 8
Triglycerides (mg/dL)
Mean Change from Post-Supplementation in Insulin at 8 weeks
Time Frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks
Time Frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks
Time Frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks
Time Frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks
Time Frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks
Time Frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks
Time Frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Intervention in Total Cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks
Time Frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks
Time Frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Intervention in Triglycerides at 10 weeks
Time Frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Post-Intervention in Insulin at 10 weeks
Time Frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks
Time Frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Post-Intervention in Body weight at 10 weeks
Time Frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks
Time Frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Secondary Outcomes
- Mean Change from Baseline in Butyrate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Serum Acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Fecal acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Bacterial Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Propionate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Butyrate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Supplementation in Bacterial Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Serum Acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Fecal acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Propionate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Butyrate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Intervention in Bacterial Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Serum Acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Fecal acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Propionate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Butyrate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Bacterial Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Serum Acetate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Fecal acetate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Propionate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Butyrate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Bacterial Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Serum Acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Fecal acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Propionate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Bacterial Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Serum Acetate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Fecal acetate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Propionate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Butyrate Profile at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 4 weeks(Post-Supplementation at week 4)
- Mean Change from Baseline in Bacterial Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Serum Acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Fecal acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Propionate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Butyrate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks(Post-Intervention at week 8)
- Mean Change from Baseline in Serum Acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Fecal acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Bacterial Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Propionate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Butyrate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides at 10 weeks(Post-Detraining at week 10)
- Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Supplementation in Bacterial Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Serum Acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Fecal acetate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Propionate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Butyrate Profile at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 8 weeks(Post-Intervention at week 8)
- Mean Change from Post-Intervention in Bacterial Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Serum Acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Fecal acetate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Propionate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Butyrate Profile at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 10 weeks(Post-Detraining at week 10)
- Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 10 weeks(Post-Detraining at week 10)
Investigators
Kembra Albracht
Assistant Professor
Texas Tech University