Efficacy and Safety of Zenoctil in Reducing Body Weight

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Zenoctil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zenoctil<br> | Dietary Supplement: Zenoctil<br>* 3 tablets 2 times daily<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 3 tablets 2 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Body Weight (kg) | Change in mean body weight at week 12 compared to baseline. | 12 weeks | 
| Change in Mean Body Fat (kg) | Change in mean body fat at week 12 compared to baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Lost at Least 3% of Baseline Body Weight |  | 12 weeks | 
| Changes in Waist Circumference (cm) |  | 12 weeks | 
| Changes in Hip Circumference |  | 12 weeks | 
| Changes in Waist-hip-ratio |  | 12 weeks | 
| Changes in Body Fat Content (%) |  | 12 weeks | 
| Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ) |  | 12 weeks | 
| Subjects' Global Feeling of Satiety | 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. | 12 weeks | 
| Changes in Body Fat Free Mass (kg) |  | 12 weeks | 
| Global Evaluation of Safety by Investigators | The investigators evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor. | 12 weeks | 
| Global Evaluation of Safety by Subjects | The subjects evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor. | 12 weeks | 
| Global Evaluation of Efficacy by Subjects | The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, weight loss, body fat, waist circumference, satiety, appetite