Efficacy and Safety of Zenoctil in Reducing Body Weight

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423617
• Other study ID #: INQ/005611
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2011
• Last updated: April 5, 2015
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Overweight

Intervention

Dietary Supplement:
• Zenoctil
3 tablets 2 times daily

Other:
• Placebo
3 tablets 2 times daily

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Body Weight (kg)	Change in mean body weight at week 12 compared to baseline.	12 weeks	No
Primary	Change in Mean Body Fat (kg)	Change in mean body fat at week 12 compared to baseline	12 weeks	No
Secondary	Number of Subjects Who Lost at Least 3% of Baseline Body Weight		12 weeks	No
Secondary	Changes in Waist Circumference (cm)		12 weeks	No
Secondary	Changes in Hip Circumference		12 weeks	No
Secondary	Changes in Waist-hip-ratio		12 weeks	No
Secondary	Changes in Body Fat Content (%)		12 weeks	No
Secondary	Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)		12 weeks	No
Secondary	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	No
Secondary	Changes in Body Fat Free Mass (kg)		12 weeks	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No