Phase 3
Completed N=92
Efficacy and Safety of Zenoctil in Reducing Body Weight
Source: ClinicalTrials.gov NCT01423617 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Change in Mean Body Weight (kg) — -2.26; -0.56 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Body Weight (kg) |
-2.26; -0.56 | — |
| PRIMARY Change in Mean Body Fat (kg) |
-1.12; 0.37 | — |
| SECONDARY Number of Subjects Who Lost at Least 3% of Baseline Body Weight |
24; 8 | — |
| SECONDARY Changes in Waist Circumference (cm) |
-2.00; -0.69 | — |
| SECONDARY Changes in Hip Circumference |
-1.54; 0.64 | — |
| SECONDARY Changes in Waist-hip-ratio |
— | — |
| SECONDARY Changes in Body Fat Content (%) |
— | — |
| SECONDARY Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ) |
— | — |
| SECONDARY Subjects' Global Feeling of Satiety |
— | — |
| SECONDARY Changes in Body Fat Free Mass (kg) |
— | — |
| SECONDARY Global Evaluation of Safety by Investigators |
— | — |
| SECONDARY Global Evaluation of Safety by Subjects |
— | — |
| SECONDARY Global Evaluation of Efficacy by Subjects |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01423617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.