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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Experimental: Group 1: Spirulina platensis
* Dietary Supplement: Experimental: Group 2: Chlorella vulgaris
* Dietary Supplement: Placebo Comparator: Group 3: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microalgae, lipid profile, metabolic syndrome, pilot