Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

Hypertension Clinical Trial

Official title:

Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114563
• Other study ID #: HRBD 41/26.05.2023
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2024
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 15, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension
• Overweight
• Overweight and Obesity
• PreDiabetes

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
Agricultural University of Athens	Hellenic Agricultural Organization DEMETER

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fasting Blood Glucose Levels	Blood glucose levels were determined at baseline, end of study, and at 12 weeks	Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Primary	Change in Total Cholesterol Levels	Total cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention	Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Primary	Change in HDL-cholesterol Levels	HDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention	Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Primary	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	Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Primary	Systolic Blood Pressure	Systolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention	Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Primary	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	Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Primary	Diastolic Blood Pressure	Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention	Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Secondary	Change in energy intake	Change in energy intake (kcal/day) over the course of the study	Baseline to 12 weeks (3 months)
Secondary	Change in Blood Insulin Levels	Blood insulin levels were determined before diet intervention, at 8 weeks, and at 12 weeks after diet intervention	Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Secondary	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	Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)
Secondary	Change in basal metabolic rate (BMR)	Change in basal metabolic rate (kcal/day) over the course of the study	Baseline to 12 weeks (3 months)
Secondary	Change in central aortic blood pressure	Significant change in central pressure (mmHg)	Baseline to 8 weeks and to 12 weeks (3 months)
Secondary	Change in body weight	Change in body weight over the course of the study	Baseline to 12 weeks (3 months)
Secondary	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	Baseline to 8 weeks (2 months)
Secondary	Time in target glucose range	Time spent in target glucose range of 70 to 180 mg/dL using FreeStyle Libre Continuous Glucose Monitor System	Baseline to 8 weeks (2 months)
Secondary	Glucose management indicator	Continuous glucose measurement (CGM) metric that indicates average blood glucose	Baseline to 8 weeks (2 months)
Secondary	Co-efficient of variation of glucose	CGM metric that measures variability in CGM values	Baseline to 8 weeks (2 months)
Secondary	Physical activity measures	Number of minutes of physical activity in the past week before visit	Baseline to 12 weeks (3 months)
Secondary	Change in Pulse Wave Velocity (PWV)	PWV using a noninvasive device was measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Secondary	Change in C-reactive Protein levels	C-reactive Protein levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Secondary	Change in interleukin-6 (IL-6) levels	IL-6 levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Secondary	Change in vitamin D levels	vitamin D levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Secondary	Change in serum iron levels	Serum iron levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Secondary	Change in ferritin levels	Ferritin levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)