Efficacy and Safety of Zenoctil in Reducing Body Weight
Condition: Overweight
MeSH terms: Overweight; Body Weight
Intervention: Zenoctil; Placebo
Intervention description: 3 tablets 2 times daily; 3 tablets 2 times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: overweight; weight loss; body fat; waist circumference; satiety; appetite

Summary:

      The intention of the study is to evaluate the safety and potential body weight and body fat
      loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind,
      placebo-controlled, parallel study conducted in Caucasian subjects.

      This study will also include a diet plan for each subject, calculated based on gender, age,
      and energy requirements; and adjusted to be slightly hypocaloric.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian males and females, age 18 to 60 years

          -  25 kg/m2 ≤ BMI ≤32 kg/m2

          -  Expressed desire for weight loss

          -  Accustomed to 3 main meals a day

          -  Consistent and stable body weight 3 months prior to study enrollment

          -  Commitment to avoid the use of other weight loss products/programs during the study

          -  Commitment to adhere to diet recommendation

          -  Females' agreement to use appropriate birth control methods during the active study
             period

          -  Subject declares in writing his/her consent to participate, understands requirements
             of the study and is willing to comply

        Exclusion Criteria:

          -  Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of
             Lythraceae family), caffeine, tannins

          -  History of diabetes mellitus or other endocrine disorders

          -  Fasting blood glucose >7 mmol/L

          -  Treatment with systemic corticosteroids within the last 12 months

          -  Current use of antidepressants

          -  Uncontrolled hypertension (>160/110) or other uncontrolled cardiac, pulmonary, renal,
             or liver disease, determined to be clinically significant by the investigator

          -  Presence of acute or history of chronic gastrointestinal disease

          -  Schizophrenia or other diagnosed psychiatric disorders

          -  Any other acute or chronic disease or any other medical condition which, in the
             investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)

          -  Bariatric surgery

          -  Abdominal surgery within the last 6 months

          -  History of eating disorders like bulimia, anorexia nervosa

          -  Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3
             months

          -  Pregnancy or nursing

          -  Any medication or use of products for the treatment of obesity (e.g., fat binder,
             carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the
             last 6 weeks

          -  More than 3 hours strenuous sport activity per week

          -  History of abuse of drugs, alcohol or medication

          -  Smoking cessation within the 6 months prior to this study

          -  Incompliance due to language difficulties

          -  Participation in another study during the last 4 weeks

          -  Clinically relevant excursions of safety parameters