Metabolic Syndrome
Conditions
Keywords
microalgae, lipid profile, metabolic syndrome, pilot
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTExperimental: Group 1: Spirulina platensis
16 g/day (two doses of 8g)
DIETARY_SUPPLEMENTExperimental: Group 2: Chlorella vulgaris
16 g/day (two doses of 8g)
DIETARY_SUPPLEMENTPlacebo Comparator: Group 3: Control
16 g/day (two doses of 8g)
Sponsors
AlgaEnergy, S.A.
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cholesterol | Change from baseline at 30 days | Biomarker of metabolic syndrome |
| Serum HDL | Change from baseline at 30 days | Biomarker of lipid profile quality |
| Serum LDL syndrome biomarker | Change from baseline at 30 days | Biomarker of lipid profile quality |
| Triglycerides (TAG) | Change from baseline at 30 days | Biomarker of lipid profile quality |
| Apolipoprotein A | Change from baseline at 30 days | Metabolic syndrome biomarker |
| Apolipoprotein B | Change from baseline at 30 days | Metabolic syndrome biomarker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro | Change from baseline at 30 days | Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness |
| Dietary intake | Change from baseline at 30 days | Changes in diet composition through 24-hour dietary record |
| Glucose | Change from baseline at 30 days | Concentration of glucose |
| Blood count | Change from baseline at 30 days | Concentration of blood |
| Creatinine | Change from baseline at 30 days | Concentration of creatinine |
| Calcium | Change from baseline at 30 days | Concentration of minerals |
| Urate | Change from baseline at 30 days | Concentration of safety marker |
| Body weight | Change from baseline at 30 days | Changes on anthropometric characteristics |
| Tolerance | Change from baseline at 30 days | Occurrence and frequency of gastrointestinal symptoms |
| Body Mass Index | Change from baseline at 30 days | Changes on anthropometric characteristics |
| Waist circumference | Change from baseline at 30 days | Changes on anthropometric characteristics |
| Adherence | Change from baseline at 30 days | Changes in the number of consumed pills |
Countries
Spain
Outcome results
None listed