Food Supplement Effect on Overweight or Moderate Obesity
NCT ID: NCT05178667
Last Updated: 2022-12-16
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
129 participants
INTERVENTIONAL
2022-01-06
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
High dose
Food supplements are consumed during 3 months by healthy volunteers.
Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
Low dose
Food supplements are consumed during 3 months by healthy volunteers.
Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
Maltodextrin
Food supplements are consumed during 3 months by healthy volunteers.
Interventions
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High dose
Food supplements are consumed during 3 months by healthy volunteers.
Low dose
Food supplements are consumed during 3 months by healthy volunteers.
Maltodextrin
Food supplements are consumed during 3 months by healthy volunteers.
Eligibility Criteria
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Inclusion Criteria
* Having a fat mass (measured by impedance balance in kg) according to the following table:
Men 18-29 years : ≥ 21.2 kg; Men 30-49 years : ≥ 21.6 kg; Men 50-65 years : ≥ 23.8 kg; Women 18-29 years : ≥ 31.4 kg; Women30-49 years : ≥ 31.8 kg; Women 50-65 years : ≥ 33.9 kg.
* Willing to observe dietetic plan in accordance with dietitian evaluation,
* Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
* Affiliated with a social security scheme.
Exclusion Criteria
* Fasting total cholesterol ≥ 3.0 g / L
* Fasting triglycerides\> 2.5 g / L
* with heterozygous familial hypercholesterolemia,
* Diabetes treated or not with medication,
* With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,
* TSH abnormal or not stable for at least 3 months,
* History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,
* With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,
* Taking drugs known to have an impact on weight management (corticosteroids, neuroleptics, anti-HIV triple therapy, etc.) in the month preceding inclusion and / or likely to consume them during the test,
* Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
* Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,
* Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,
* Non stable weight during the last 6 months (\>5% change in total weight),
* With metal implant (to allow DEXA measurement),
* Blood donation in the month before the start of the study and during the study,
* Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and / or likely to take during the test,
* Following or having followed a hypocaloric diet (energy intake \<1,500 kCal / day) in the month preceding inclusion and / or likely to undertake this diet during the test,
* Following a particular diet (vegan),
* Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
* Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,
* Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,
* Bariatric surgery or who has a gastroplasty ring,
* Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,
* Consuming illicit drugs,
* Using topical anti-cellulite treatments,
* For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,
* Known allergy to one of the component of the supplement (carrot and rose hip),
* Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,
* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
* Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
* Presenting a psychological or linguistic incapability to sign the informed consent,
* Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
20 Years
65 Years
ALL
Yes
Sponsors
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Institut Pasteur de Lille
OTHER
Responsible Party
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Jean-Michel Lecerf
Principal investigator
Principal Investigators
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Jean-Michel Lecerf, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur de Lille - NutrInvest
Locations
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NutrInvest - Institut Pasteur de Lille
Lille, Nord, France
Institute of Cardiometabolism And Nutrition
Paris, , France
Countries
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Other Identifiers
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2021-A02422-39
Identifier Type: -
Identifier Source: org_study_id