Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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
结局指标
主要结局
Systolic Blood Pressure
时间窗: 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 Total Cholesterol Levels
时间窗: 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 Fasting Blood Glucose Levels
时间窗: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Blood glucose levels were determined at baseline, end of study, and at 12 weeks
Change in HDL-cholesterol Levels
时间窗: 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
时间窗: 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
时间窗: 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
Change in LDL-cholesterol Levels
时间窗: 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
次要结局
- 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))
研究者
Aimilia Papakonstantinou
Assistant Professor
Agricultural University of Athens