Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

Sponsor

Agricultural University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT06114563

Collaborator

(none)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity PreDiabetes Hypertension Dyslipidemias	Other: Spirulina yogurt Other: Conventional yogurt	N/A

Detailed Description

This randomized, single-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in 64 high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia. The participants will be divided and randomly assigned into 2 groups of 32 individuals each. Participants will consume 2 cups of either yogurt with spirulina (2 g of spirulina in each cup) or conventional yogurt (without spirulina) daily for 8 weeks as an addition to their usual dietary intake. 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. Anthropometric measurements 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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single-blind

Primary Purpose:

Treatment

Official Title:

Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals

Actual Study Start Date :

Feb 1, 2023

Actual Primary Completion Date :

Jul 31, 2023

Actual Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spirulina yogurt 2 cups of yogurt with spirulina each containing 2 g of spirulina	Other: Spirulina yogurt 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of yogurt 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 cups of conventional yogurt (without spirulina)	Other: Conventional yogurt 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of conventional yogurt (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.

Arm

Intervention/Treatment

Experimental: Spirulina yogurt

2 cups of yogurt with spirulina each containing 2 g of spirulina

Other: Spirulina yogurt

32 high cardiometabolic risk volunteers will be asked to consume 2 cups of yogurt 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 cups of conventional yogurt (without spirulina)

Other: Conventional yogurt

32 high cardiometabolic risk volunteers will be asked to consume 2 cups of conventional yogurt (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.

Outcome Measures

Primary Outcome Measures

Change in blood glucose concentrations [8 weeks, 12 weeks]
Clinically significant change in blood glucose concentrations (mg/dL)

Secondary Outcome Measures

Change in energy intake [8 weeks, 12 weeks]
Clinically significant change in energy intake (kcal/day)
Change in blood lipid levels [8 weeks, 12 weeks]
Clinically significant change in triglycerides (mg/dL), total cholesterol mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)
Change in blood insulin concentrations [8 weeks, 12 weeks]
Clinically significant change in blood insulin concentrations (μU/L)
Change in basal metabolic rate (BMR) [8 weeks, 12 weeks]
Clinically significant change in basal metabolic rate (kcal/day)
Change in central aortic blood pressure [8 weeks, 12 weeks]
Clinically significant change in central pressure (mmHg)
Change in body weight [8 weeks, 12 weeks]
Clinically significant change in body weight (kg)
Change in gut microbiome [8 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agricultural University of Athens	Athens	Attica	Greece	11855

Sponsors and Collaborators

Agricultural University of Athens

Investigators

Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens

ClinicalTrials.gov Identifier:

NCT06114563

Other Study ID Numbers:

HRBD 41/26.05.2023

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens

spirulina

yogurt

cardiometabolic risk factors

Additional relevant MeSH terms:

Overweight

Dyslipidemias

Study Results

No Results Posted as of Nov 3, 2023