Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT05343858
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.

Detailed Description

A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).

The investigators included 30 participants between 18 and 65 years (BMI ≥25 and \<40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-06
• Study Start: 2019-09-09
• Primary Completion: 2019-10-09
• Study Completion: 2021-01-31
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women from 18 to 65 years old.
• Body Mass Index (BMI) ≥25 and <40 kg/m2.
• Cardiovascular risk <10%
• Adequate cultural level and understanding
• Agree to participate in the study

Exclusion Criteria

• Subjects with BMI ≥40 or <25 kg /m2
• Subjects diagnosed with Diabetes Mellitus.
• Subjects with dyslipidemia on pharmacological treatment
• Subjects with hypertension on pharmacological treatment
• Subjects with established diagnosis of eating disorder
• Smokers or those subjects with high alcohol consumption
• Subjects under pharmacological treatment
• Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
• Subjects with sensory problems
• Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
• Pregnant or breastfeeding women
• Women with menstrual irregularities
• Subjects with intense physical activity
• Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
• Subjects with a diagnosis of celiac disease or a gluten intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum cholesterol	Change from baseline at 30 days	Biomarker of metabolic syndrome
Serum HDL	Change from baseline at 30 days	Biomarker of lipid profile quality
Serum LDL syndrome biomarker	Change from baseline at 30 days	Biomarker of lipid profile quality
Apolipoprotein B	Change from baseline at 30 days	Metabolic syndrome biomarker
Triglycerides (TAG)	Change from baseline at 30 days	Biomarker of lipid profile quality
Apolipoprotein A	Change from baseline at 30 days	Metabolic syndrome biomarker

Secondary Outcome Measures

Name	Time	Method
Body weight	Change from baseline at 30 days	Changes on anthropometric characteristics
Calcium	Change from baseline at 30 days	Concentration of minerals
Dietary intake	Change from baseline at 30 days	Changes in diet composition through 24-hour dietary record
Blood count	Change from baseline at 30 days	Concentration of blood
Tolerance	Change from baseline at 30 days	Occurrence and frequency of gastrointestinal symptoms
Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro	Change from baseline at 30 days	Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness
Glucose	Change from baseline at 30 days	Concentration of glucose
Urate	Change from baseline at 30 days	Concentration of safety marker
Creatinine	Change from baseline at 30 days	Concentration of creatinine
Body Mass Index	Change from baseline at 30 days	Changes on anthropometric characteristics
Waist circumference	Change from baseline at 30 days	Changes on anthropometric characteristics
Adherence	Change from baseline at 30 days	Changes in the number of consumed pills

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain