Clinical trial NCT05178667: Food Supplement Effect on Overweight or Moderate Obesity
Official title: Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.


Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 35 kg / m² (limits excluded),
* 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:

* Dyslipidemia or hyperlipidemia:

  * 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.

Primary outcomes:
measure: Change from Baseline weight at 3 months
timeFrame: 0 month (inclusion), 3 months
Secondary outcomes:
measure: Body mass composition by DEXA (dual energy x-ray absorptiometry)
timeFrame: 0 month (inclusion), 3 months
measure: Anthropometric parameters
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Fasting glycemia
timeFrame: 0 month (inclusion), 3 months
measure: Insulinemia
timeFrame: 0 month (inclusion), 3 months
measure: HbA1c
timeFrame: 0 month (inclusion), 3 months
measure: HOMA index
timeFrame: 0 month (inclusion), 3 months
measure: Lipid metabolism
timeFrame: 0 month (inclusion), 3 months
measure: Free fatty acids
timeFrame: 0 month (inclusion), 3 months
measure: Hepatic metabolism
timeFrame: 0 month (inclusion), 3 months
measure: Transaminases
timeFrame: 0 month (inclusion), 3 months
measure: Sedimentation rate
timeFrame: 0 month (inclusion), 3 months
measure: Blood count
timeFrame: 0 month (inclusion), 3 months
measure: Thyroid Stimulating Hormone
timeFrame: 0 month (inclusion), 3 months
measure: High sensible C-reactive protein
timeFrame: 0 month (inclusion), 3 months
measure: Heart rate
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Blood pressure
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Body mass composition by impedancemetry
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Weight
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Height
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
measure: Body Mass Index
timeFrame: 0 month (inclusion), 1 month, 2 months, 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
city: Paris
country: France
facility: Institute of Cardiometabolism And Nutrition
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References: