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

Metabolic Syndrome Clinical Trial

— ALGAENERGY  

Official title:

Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343858
• Other study ID #: HULP 5296
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2019
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2021
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Experimental: Group 1: Spirulina platensis
16 g/day (two doses of 8g)
• Experimental: Group 2: Chlorella vulgaris
16 g/day (two doses of 8g)
• Placebo Comparator: Group 3: Control
16 g/day (two doses of 8g)

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	AlgaEnergy, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum cholesterol	Biomarker of metabolic syndrome	Change from baseline at 30 days
Primary	Serum HDL	Biomarker of lipid profile quality	Change from baseline at 30 days
Primary	Serum LDL syndrome biomarker	Biomarker of lipid profile quality	Change from baseline at 30 days
Primary	Triglycerides (TAG)	Biomarker of lipid profile quality	Change from baseline at 30 days
Primary	Apolipoprotein A	Metabolic syndrome biomarker	Change from baseline at 30 days
Primary	Apolipoprotein B	Metabolic syndrome biomarker	Change from baseline at 30 days
Secondary	Blood count	Concentration of blood	Change from baseline at 30 days
Secondary	Body weight	Changes on anthropometric characteristics	Change from baseline at 30 days
Secondary	Tolerance	Occurrence and frequency of gastrointestinal symptoms	Change from baseline at 30 days
Secondary	Body Mass Index	Changes on anthropometric characteristics	Change from baseline at 30 days
Secondary	Waist circumference	Changes on anthropometric characteristics	Change from baseline at 30 days
Secondary	Adherence	Changes in the number of consumed pills	Change from baseline at 30 days
Secondary	Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro	Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness	Change from baseline at 30 days
Secondary	Dietary intake	Changes in diet composition through 24-hour dietary record	Change from baseline at 30 days
Secondary	Glucose	Concentration of glucose	Change from baseline at 30 days
Secondary	Urate	Concentration of safety marker	Change from baseline at 30 days
Secondary	Creatinine	Concentration of creatinine	Change from baseline at 30 days
Secondary	Calcium	Concentration of minerals	Change from baseline at 30 days