Status:
COMPLETED
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
AlgaEnergy, S.A.
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
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 choles...
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05343858
Start Date
September 9 2019
End Date
January 31 2021
Last Update
May 11 2022
Active Locations (1)
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1
Institute for Health Research IdiPAZ
Madrid, Spain, 28046