Paleo Diet 8wk Feasibility in Overweight Adults
- Conditions
- Overweight and Obesity
- Interventions
- Other: Diet
- Registration Number
- NCT03814473
- Lead Sponsor
- University of Houston
- Brief Summary
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period.
- Detailed Description
The Paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. The feasibility of the Paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet follow an ad libitum self-administered Paleo diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers. Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm Western diet consumption at pre-, track compliance, and to assess dietary changes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Age: 18-55 years
- BMI > 25 kg/m2
- Currently consuming a typical Western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain)
- known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
- smoking and/or smokeless tobacco users
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dietary intervention Diet All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
- Primary Outcome Measures
Name Time Method Serum biomarkers of energy homeostasis Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
Serum growth factor Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Serum cytokines Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
Serum adipokines Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Serum omentin (ng/mL) and nesfatin (ng/mL)
Serum glucose metabolism biomarkers Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)
- Secondary Outcome Measures
Name Time Method Body weight Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Measurement of participant's body weight (kg)
Body height pre-intervention (week zero) Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m\^2)
Subcutaneous body fat Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Skin fold thickness (mm) of body fat
Dietary composition Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) 3-day food diary to approximate macronutrient composition (grams)
Dietary energy intake Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) 3-day food diary to approximate total energy intake (kcal)
Waist and hip circumference Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
Blood pressure Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) Measurement of blood pressure from the arm (mmHg)
Trial Locations
- Locations (2)
Chatham University
🇺🇸Pittsburgh, Pennsylvania, United States
University of Houston
🇺🇸Houston, Texas, United States