Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

NCT ID: NCT06114563

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-09-15

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.

Conditions

Overweight and Obesity; PreDiabetes; Hypertension; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Spirulina yogurt

2 yogurts with spirulina each containing 2 g of spirulina

Group Type: EXPERIMENTAL

Spirulina yogurt

Intervention Type: 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

2 conventional yogurts (without spirulina)

Group Type: ACTIVE_COMPARATOR

Conventional yogurt

Intervention Type: 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.

Interventions

Spirulina yogurt

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.

Intervention Type: OTHER

Conventional yogurt

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Agricultural Organization DEMETER

UNKNOWN

Sponsor Role: collaborator

Agricultural University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Aimilia Papakonstantinou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

Agricultural University of Athens

Athens, Attica, Greece

Countries

Greece

Other Identifiers

HRBD 41/26.05.2023

Identifier Type: -

Identifier Source: org_study_id