Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
NCT ID: NCT05343858
Last Updated: 2022-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-09-09
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Spirulina platensis
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis
Experimental: Group 1: Spirulina platensis
16 g/day (two doses of 8g)
Group 2: Chlorella vulgaris
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris
Experimental: Group 2: Chlorella vulgaris
16 g/day (two doses of 8g)
Group 3: Control
10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement
Placebo Comparator: Group 3: Control
16 g/day (two doses of 8g)
Interventions
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Experimental: Group 1: Spirulina platensis
16 g/day (two doses of 8g)
Experimental: Group 2: Chlorella vulgaris
16 g/day (two doses of 8g)
Placebo Comparator: Group 3: Control
16 g/day (two doses of 8g)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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AlgaEnergy, S.A.
UNKNOWN
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Carmen Gómez-Candela
Role: PRINCIPAL_INVESTIGATOR
La Paz University Hospital
Locations
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Institute for Health Research IdiPAZ
Madrid, , Spain
Countries
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Other Identifiers
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HULP 5296
Identifier Type: -
Identifier Source: org_study_id
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