Efficacy and Safety of Zenoctil in Reducing Body Weight

• Difference in mean loss of body weight (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Difference in mean loss of body fat (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

• Proportion of subjects who lost at least 3% and 5% of baseline body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Changes in waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Changes in hip circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Changes in waist-hip-ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Changes in body fat content (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Changes in hunger, eating, and food-craving related items from the Control of Eating Questionnaire (COEQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Subjects' global feeling of satiety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = "no"; 1 = "slightly", 2 = "moderate" and 3 = "strong".
• Changes in body fat free mass (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Global evaluation of safety by investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
• Global evaluation of safety by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
• Global evaluation of efficacy by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

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.

• Dietary Supplement: Zenoctil
  3 tablets 2 times daily
• Other: Placebo
  3 tablets 2 times daily

• Active Comparator: Zenoctil
  Intervention: Dietary Supplement: Zenoctil
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

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