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Completed

NCT Number: NCT06114563

Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

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

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Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agricultural University of Athens

Athens, Attica, 11855, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina yogurt

Other

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 yogurt

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Change in energy intake

    Time frame: Baseline to 12 weeks (3 months)

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

  2. Change in Blood Insulin Levels

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

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

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

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

    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

  4. Change in basal metabolic rate (BMR)

    Time frame: Baseline to 12 weeks (3 months)

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

  5. Change in central aortic blood pressure

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

    Significant change in central pressure (mmHg)

  6. Change in body weight

    Time frame: Baseline to 12 weeks (3 months)

    Change in body weight over the course of the study

  7. Change in gut microbiome

    Time frame: Baseline to 8 weeks (2 months)

    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. Time in target glucose range

    Time frame: Baseline to 8 weeks (2 months)

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

  9. Glucose management indicator

    Time frame: Baseline to 8 weeks (2 months)

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

  10. Co-efficient of variation of glucose

    Time frame: Baseline to 8 weeks (2 months)

    CGM metric that measures variability in CGM values

  11. Physical activity measures

    Time frame: Baseline to 12 weeks (3 months)

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

  12. Change in Pulse Wave Velocity (PWV)

    Time frame: Baseline to 12 weeks (3 months)

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

  13. Change in C-reactive Protein levels

    Time frame: Baseline to 12 weeks (3 months)

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

  14. Change in interleukin-6 (IL-6) levels

    Time frame: Baseline to 12 weeks (3 months)

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

  15. Change in vitamin D levels

    Time frame: Baseline to 12 weeks (3 months)

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

  16. Change in serum iron levels

    Time frame: Baseline to 12 weeks (3 months)

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

  17. Change in ferritin levels

    Time frame: Baseline to 12 weeks (3 months)

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

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Collaborators

  • Hellenic Agricultural Organization DEMETER

Registry information

Official study title

Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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