Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

Study Overview
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Brief Summary
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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
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This randomized, single-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in 64 high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia. The participants will be divided and randomly assigned into 2 groups of 32 individuals each. Participants will consume 2 cups of either yogurt with spirulina (2 g of spirulina in each cup) or conventional yogurt (without spirulina) daily for 8 weeks as an addition to their usual dietary intake. 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. Anthropometric measurements 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.

Official Title
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Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals

Conditions
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Overweight and Obesity, PreDiabetes, Hypertension, Dyslipidemias

Intervention / Treatment
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* Other: Spirulina yogurt
* Other: Conventional yogurt


Participation Criteria
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Eligibility Criteria
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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 Cancer Current spirulina intake

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina yogurt<br>2 cups of yogurt with spirulina each containing 2 g of spirulina | Other: Spirulina yogurt<br>* 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of yogurt with spirulina, each containing 2 g spirulina, daily for 8 weeks, without any other change in their dietary habits and physical activity.<br>|
| Active Comparator: Conventional yogurt<br>2 cups of conventional yogurt (without spirulina) | Other: Conventional yogurt<br>* 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of conventional yogurt (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood glucose concentrations | Clinically significant change in blood glucose concentrations (mg/dL) | 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy intake | Clinically significant change in energy intake (kcal/day) | 8 weeks, 12 weeks | 
| Change in blood lipid levels | Clinically significant change in triglycerides (mg/dL), total cholesterol mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl) | 8 weeks, 12 weeks | 
| Change in blood insulin concentrations | Clinically significant change in blood insulin concentrations (μU/L) | 8 weeks, 12 weeks | 
| Change in basal metabolic rate (BMR) | Clinically significant change in basal metabolic rate (kcal/day) | 8 weeks, 12 weeks | 
| Change in central aortic blood pressure | Clinically significant change in central pressure (mmHg) | 8 weeks, 12 weeks | 
| Change in body weight | Clinically significant change in body weight (kg) | 8 weeks, 12 weeks | 
| Change in gut microbiome | The microbial composition in fecal samples will be measured via taxonomic profiling by 16S (V3-V4 region) ribosomal RNA gene amplicon sequencing using the MiSeq Illumina platform (v3 300bp pair-end sequencing) to identify a wide diversity of microbes | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spirulina, yogurt, cardiometabolic risk factors