Clinical trial: Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers (NCT02246699)

Eligibility criteria:
Inclusion Criteria:

          -  Males and females volunteers, able to read and write.

          -  Subject with 25 ≤ Body Mass Index ≤ 35 kg/m².

          -  Subject with a good physical condition based on the subject's interview and the
             clinical exam performed by the Investigator.

          -  Subject with stable body weight (< 5% variation) within the last 3 months prior to
             screening (based on interview).

          -  Written informed consent provided prior to screening, after receiving and
             understanding the subject information.

          -  Subject willing to lose weight.

          -  Subject accepting to follow diet and lifestyle instructions throughout the study.

          -  Subject willing to take study capsules three times a day for 3 months and 1 week and
             undergo other study-related procedures.

          -  Registered with the French Social Security, in agreement with the French law on
             biomedical experimentation.

        Exclusion Criteria:

          -  Smoker or former smoker having stopped within 2 months prior to screening visit.

          -  Subject with a history of alcohol or drug abuse.

          -  Subject with physical activity more than 3 hours per week.

          -  Subject with any sensitivity or allergy to any of the products used within this
             clinical trial.

          -  Subject with history of eating disorder (anorexia nervosa, bulimia nervosa).

          -  Subject having used weight reduction treatments or products during the last 3 months
             prior to screening visit.

          -  Subject with significant gastrointestinal disease (e.g. coeliac disease,
             pancreatitis), signs of intestinal obstruction or medical history of constipation.

          -  Intake of chronic medication which could interfere with study parameters (weight,
             appetite, satiety, lipid blood levels, glycemia, gastrointestinal function), having an
             effect on digestion or absorption of nutrients, excepted oestroprogestative or
             progestative contraception started at least three months before the screening visit.

          -  Female subject planning a pregnancy, pregnant or breastfeeding.

          -  Female subject without efficient contraceptive method.

          -  Subject with history of bariatric surgery.

          -  Subject with known systemic disease such as cancer, human immunodeficiency virus (HIV)
             seropositivity.

          -  Subject with type 1 or type 2 diabetes mellitus.

          -  Subject with history of significant medical or surgical event requiring
             hospitalization during the 3 months prior the screening visit.

          -  Subject having, had or scheduling to have an exam that uses barium, a radioisotope
             injection, or oral or intravenous contrast material within 2 weeks prior screening
             visit and during the study.

          -  Participation to any other clinical trial simultaneously and/or within 1 month prior
             the screening visit.

          -  Subject who has donated blood or blood products within the previous month prior to
             screening or who plans to donate blood or blood products at any time during the trial
             and in the 3 months following the end of the study.

          -  Subject judged unlikely to comply with study product intake (screening compliance <
             80%) and with diet and lifestyle instructions.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction