Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers

NCT06114563 | Completed DMC

• 1 other identifier: HRBD 41/26.05.2023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight and Obesity; PreDiabetes; Hypertension; Dyslipidemias

Keywords

spirulina; yogurt; cardiometabolic risk factors

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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 Outcomes (17)

• Change in energy intake

  Baseline to 12 weeks (3 months)

• Change in Blood Insulin Levels

  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)

  Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)

• Change in basal metabolic rate (BMR)

  Baseline to 12 weeks (3 months)

• Change in central aortic blood pressure

  Baseline to 8 weeks and to 12 weeks (3 months)

Study Arms (2)

Spirulina yogurt

EXPERIMENTAL

2 yogurts with spirulina each containing 2 g of spirulina

Other: Spirulina yogurt

Conventional yogurt

ACTIVE COMPARATOR

2 conventional yogurts (without spirulina)

Other: Conventional yogurt

Interventions

Spirulina yogurt 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.

Spirulina yogurt

Conventional yogurt 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.

Conventional yogurt

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Total cholesterol \> 200 mg/dL, and/or LDL-C \> 100 mg/dL, and/or triglycerides \> 150 mg/dL\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead
• Hellenic Agricultural Organization DEMETER: collaborator

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Officials

• Emilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: February 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: September 15, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)