Clinical trial NCT06114563: Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers
Official title: Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
PreDiabetes
Hypertension
Dyslipidemias
Keywords: spirulina
yogurt
cardiometabolic risk factors
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Hellenic Agricultural Organization DEMETER
First posted: 2023-11-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Fasting Blood Glucose Levels
timeFrame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
measure: Change in Total Cholesterol Levels
timeFrame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
measure: Change in HDL-cholesterol Levels
timeFrame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
measure: Change in LDL-cholesterol Levels
timeFrame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
measure: Systolic Blood Pressure
timeFrame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
measure: Change in Triglyceride Levels
timeFrame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
measure: Diastolic Blood Pressure
timeFrame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Secondary outcomes:
measure: Change in energy intake
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in Blood Insulin Levels
timeFrame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
measure: Oral Glucose Tolerance Test (OGGT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
timeFrame: Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)
measure: Change in basal metabolic rate (BMR)
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in central aortic blood pressure
timeFrame: Baseline to 8 weeks and to 12 weeks (3 months)
measure: Change in body weight
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in gut microbiome
timeFrame: Baseline to 8 weeks (2 months)
measure: Time in target glucose range
timeFrame: Baseline to 8 weeks (2 months)
measure: Glucose management indicator
timeFrame: Baseline to 8 weeks (2 months)
measure: Co-efficient of variation of glucose
timeFrame: Baseline to 8 weeks (2 months)
measure: Physical activity measures
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in C-reactive Protein levels
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in interleukin-6 (IL-6) levels
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in vitamin D levels
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in serum iron levels
timeFrame: Baseline to 12 weeks (3 months)
measure: Change in ferritin levels
timeFrame: Baseline to 12 weeks (3 months)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References: