Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias; PreDiabetes; Overweight and Obesity
• Intervention / Treatment: Other: Spirulina yogurt; Other: Conventional yogurt

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11855
      • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spirulina yogurt; 2 yogurts with spirulina each containing 2 g of spirulina	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.
Active Comparator: Conventional yogurt; 2 conventional yogurts (without spirulina)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in energy intake	Change in energy intake (kcal/day) over the course of the study	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	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	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	Baseline to 12 weeks (3 months)
Change in central aortic blood pressure	Significant change in central pressure (mmHg)	Baseline to 8 weeks and to 12 weeks (3 months)
Change in body weight	Change in body weight over the course of the study	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	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	Baseline to 8 weeks (2 months)
Glucose management indicator	Continuous glucose measurement (CGM) metric that indicates average blood glucose	Baseline to 8 weeks (2 months)
Co-efficient of variation of glucose	CGM metric that measures variability in CGM values	Baseline to 8 weeks (2 months)
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)
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)
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)
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)
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)
Change in ferritin levels	Ferritin levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention	Baseline to 12 weeks (3 months)
Physical activity measures	Number of minutes of physical activity in the past week before visit	Baseline to 12 weeks (3 months)

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Collaborators: Hellenic Agricultural Organization DEMETER
• Investigators: Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: yogurt; cardiometabolic risk factors; spirulina
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Dyslipidemias; Overweight
• Other Study ID Numbers: HRBD 41/26.05.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No