Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in Total Cholesterol Levels
Study Overview
Brief Summary
The effects of yogurt with spirulina consumption compared to conventional yogurt (without spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease
Detailed Description
This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia and following a Westernized-type diet. The participants will be divided and randomly assigned into 2 groups. Each participant will be instructed to consume two 200 g servings of their designated low-fat sheep yogurt daily before consuming the main meal. The intervention group will receive two spirulina-enriched yogurt desserts daily, which will provide a total of 4 g spirulina per day, while the control group will receive unfortified yogurt along with their usual Westernized-type diet. Participants in both groups will be instructed to consume the two yogurts (enriched or plain), either all at once or separately, before their main meals, along with their usual Westernized diet. No other dietary advice will be provided to participants.
Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study, at 8 weeks, and 12 weeks after the beginning of the intervention (follow-up), blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Blood lipids (total cholesterol, HDL-cholesterol, triglycerides, and LDL-cholesterol), CRP, IL-6, vitamin D, iron, ferritin, and total blood count will be measured at the beginning, 8 weeks, and 12 weeks. Anthropometric measurements (body weight and body composition analysis) will be performed at the beginning and every two weeks for 12 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, 8 weeks, and 12 weeks of the intervention. Fecal samples will be collected and analyzed to study the gut microbiome composition at the intervention's beginning and at 8 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Body Mass Index >= 25 kg/m2
- •Prediabetes [Fasting blood glucose > 100 mg/dL], or/and
- •Hypertension [Systolic blood pressure (SBP) > 130 mmHg or Diastolic blood pressure (DBP) > 80 mmHg], or/and
- •Hyperlipidemia [Total cholesterol > 200 mg/dL, and/or LDL-C > 100 mg/dL, and/or triglycerides > 150 mg/dL]
Exclusion Criteria
- •Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)
- •Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics
- •Gastrointestinal disorders
- •Pregnancy
- •Lactation
- •Alcohol abuse
- •Drug dependency
- •Body weight lowering medications and/or history of bariatric surgery
- •Depression and other psychiatric diseases
- •Current spirulina intake
Arms & Interventions
Spirulina yogurt
2 yogurts with spirulina each containing 2 g of spirulina
Intervention: Spirulina yogurt (Other)
Conventional yogurt
2 conventional yogurts (without spirulina)
Intervention: Conventional yogurt (Other)
Outcomes
Primary Outcomes
Change in Total Cholesterol Levels
Time Frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Total cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in HDL-cholesterol Levels
Time Frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
HDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in Triglyceride Levels
Time Frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Triglyceride levels were determined before diet intervention, at 8 weeks, levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Diastolic Blood Pressure
Time Frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Systolic Blood Pressure
Time Frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Systolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in LDL-cholesterol Levels
Time Frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
LDL-cholesterol levels were determined before diet intervention, at 8 weeks, LDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in Fasting Blood Glucose Levels
Time Frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Blood glucose levels were determined at baseline, end of study, and at 12 weeks
Secondary Outcomes
- Oral Glucose Tolerance Test (OGGT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)(Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months))
- Co-efficient of variation of glucose(Baseline to 8 weeks (2 months))
- Physical activity measures(Baseline to 12 weeks (3 months))
- Change in vitamin D levels(Baseline to 12 weeks (3 months))
- Change in serum iron levels(Baseline to 12 weeks (3 months))
- Change in Blood Insulin Levels(Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months))
- Change in basal metabolic rate (BMR)(Baseline to 12 weeks (3 months))
- Time in target glucose range(Baseline to 8 weeks (2 months))
- Change in Pulse Wave Velocity (PWV)(Baseline to 12 weeks (3 months))
- Change in energy intake(Baseline to 12 weeks (3 months))
- Change in central aortic blood pressure(Baseline to 8 weeks and to 12 weeks (3 months))
- Change in body weight(Baseline to 12 weeks (3 months))
- Change in gut microbiome(Baseline to 8 weeks (2 months))
- Glucose management indicator(Baseline to 8 weeks (2 months))
- Change in C-reactive Protein levels(Baseline to 12 weeks (3 months))
- Change in interleukin-6 (IL-6) levels(Baseline to 12 weeks (3 months))
- Change in ferritin levels(Baseline to 12 weeks (3 months))
Investigators
Aimilia Papakonstantinou
Assistant Professor
Agricultural University of Athens