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

Instituto de Investigación Hospital Universitario La Paz30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Experimental: Group 1: Spirulina platensisDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Experimental: Group 2: Chlorella vulgarisDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Placebo Comparator: Group 3: ControlDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute for Health Research IdiPAZ

Madrid, Spain