Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)

This is an interventional prevention trial for Obesity Read More

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.