Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

Agricultural University of Athens64 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overweight and Obesity PreDiabetes Hypertension Dyslipidemias

Interventions

Spirulina yogurtOTHER

High cardiometabolic risk volunteers will be asked to consume 2 yogurts with spirulina, each containing 2 g spirulina, daily for 8 weeks, without any other change in their dietary habits and physical activity.

Conventional yogurtOTHER

High cardiometabolic risk volunteers will be asked to consume 2 conventional yogurts (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Agricultural University of Athens

Athens, Attica, Greece

Outcomes

Primary Outcomes

Change in Fasting Blood Glucose Levels

Blood glucose levels were determined at baseline, end of study, and at 12 weeks

Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)

Change in Total Cholesterol Levels

Total cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention

Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)

Change in HDL-cholesterol Levels

HDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention

Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)

Change in LDL-cholesterol Levels

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

Time frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)

Systolic Blood Pressure

Systolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention

Time frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)

Change in Triglyceride Levels

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

Time frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)

Diastolic Blood Pressure

Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in energy intake

Change in energy intake (kcal/day) over the course of the study

Time frame: Baseline to 12 weeks (3 months)

Change in Blood Insulin Levels

Blood insulin levels were determined before diet intervention, at 8 weeks, and at 12 weeks after diet intervention

Time frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)

Oral Glucose Tolerance Test (OGGT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)

Pharmacokinetic outcome measures: Determination of insulin resistance with OGGT testing. Before and after oral consumption of 75 g of glucose, capillary glucose concentrations were measured at the following times: 0 min - before oral consumption of 75 g glucose, 30 min, 60 min, 90 min, and 120 min after oral consumption of 75 g glucose

Time frame: Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)

Change in basal metabolic rate (BMR)

Change in basal metabolic rate (kcal/day) over the course of the study

Time frame: Baseline to 12 weeks (3 months)

Change in central aortic blood pressure

Significant change in central pressure (mmHg)

Time frame: Baseline to 8 weeks and to 12 weeks (3 months)

Change in body weight

Change in body weight over the course of the study

Time frame: Baseline to 12 weeks (3 months)

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

Time frame: Baseline to 8 weeks (2 months)

Time in target glucose range

Time spent in target glucose range of 70 to 180 mg/dL using FreeStyle Libre Continuous Glucose Monitor System

Time frame: Baseline to 8 weeks (2 months)

Glucose management indicator

Continuous glucose measurement (CGM) metric that indicates average blood glucose

Time frame: Baseline to 8 weeks (2 months)

Co-efficient of variation of glucose

CGM metric that measures variability in CGM values

Time frame: Baseline to 8 weeks (2 months)

Physical activity measures

Number of minutes of physical activity in the past week before visit

Time frame: Baseline to 12 weeks (3 months)

Change in Pulse Wave Velocity (PWV)

PWV using a noninvasive device was measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)

Change in C-reactive Protein levels

C-reactive Protein levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)

Change in interleukin-6 (IL-6) levels

IL-6 levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)

Change in vitamin D levels

vitamin D levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)

Change in serum iron levels

Serum iron levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)

Change in ferritin levels

Ferritin levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention

Time frame: Baseline to 12 weeks (3 months)