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

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Placebo Comparator: Group 3: Control; Dietary Supplement: Experimental: Group 2: Chlorella vulgaris; Dietary Supplement: Experimental: Group 1: Spirulina platensis

Study type: Interventional

Funder types: Other

Identifiers

NCT05343858

HULP 5296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Group 1: Spirulina platensis

Experimental group

Description:

10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis

Treatment:

Dietary Supplement: Experimental: Group 1: Spirulina platensis

Group 2: Chlorella vulgaris

Experimental group

Description:

10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris

Treatment:

Dietary Supplement: Experimental: Group 2: Chlorella vulgaris

Group 3: Control

Placebo Comparator group

Description:

10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement

Treatment:

Dietary Supplement: Placebo Comparator: Group 3: Control