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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Experimental: Group 1: Spirulina platensis; Dietary supplement: Experimental: Group 2: Chlorella vulgaris; Dietary supplement: Placebo Comparator: Group 3: Control

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Spirulina platensis; 10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis	Dietary supplement: Experimental: Group 1: Spirulina platensis; 16 g/day (two doses of 8g)
Experimental: Group 2: Chlorella vulgaris; 10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris	Dietary supplement: Experimental: Group 2: Chlorella vulgaris; 16 g/day (two doses of 8g)
Placebo Comparator: Group 3: Control; 10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement	Dietary supplement: Placebo Comparator: Group 3: Control; 16 g/day (two doses of 8g)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood count	Concentration of blood	Change from baseline at 30 days
Body weight	Changes on anthropometric characteristics	Change from baseline at 30 days
Tolerance	Occurrence and frequency of gastrointestinal symptoms	Change from baseline at 30 days
Body Mass Index	Changes on anthropometric characteristics	Change from baseline at 30 days
Waist circumference	Changes on anthropometric characteristics	Change from baseline at 30 days
Adherence	Changes in the number of consumed pills	Change from baseline at 30 days
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
Dietary intake	Changes in diet composition through 24-hour dietary record	Change from baseline at 30 days
Glucose	Concentration of glucose	Change from baseline at 30 days
Urate	Concentration of safety marker	Change from baseline at 30 days
Creatinine	Concentration of creatinine	Change from baseline at 30 days
Calcium	Concentration of minerals	Change from baseline at 30 days

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: AlgaEnergy, S.A.
• Investigators: Principal Investigator: Carmen Gómez-Candela, La Paz University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: metabolic syndrome; lipid profile; microalgae; pilot
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: HULP 5296

Drug and device information, study documents

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