Efficacy and Safety of Zenoctil in Reducing Body Weight

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Zenoctil; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Barbara Grube

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 3 tablets 2 times daily
Active Comparator: Zenoctil	Dietary supplement: Zenoctil; 3 tablets 2 times daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Barbara Grube, MD

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 5, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: overweight; appetite; weight loss; satiety; body fat; waist circumference
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: INQ/005611