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| Name | Class |
|---|---|
| AlgaEnergy, S.A. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Spirulina platensis | Experimental | 10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis |
|
| Group 2: Chlorella vulgaris | Experimental | 10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris |
|
| Group 3: Control | Placebo Comparator | 10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Group 1: Spirulina platensis | Dietary Supplement | 16 g/day (two doses of 8g) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez-Candela | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research IdiPAZ | Madrid | 28046 | Spain |
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| Experimental: Group 2: Chlorella vulgaris | Dietary Supplement | 16 g/day (two doses of 8g) |
|
| Placebo Comparator: Group 3: Control | Dietary Supplement | 16 g/day (two doses of 8g) |
|
| 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 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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