Efficacy and Safety of Zenoctil in Reducing Body Weight

NCT ID: NCT01423617

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

Brief 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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zenoctil

Group Type: ACTIVE_COMPARATOR

Zenoctil

Intervention Type: DIETARY_SUPPLEMENT

3 tablets 2 times daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

3 tablets 2 times daily

Interventions

Zenoctil

3 tablets 2 times daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

3 tablets 2 times daily

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Grube, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Barbara Grube

Berlin, , Germany

Countries

Germany

Other Identifiers

INQ/005611

Identifier Type: -

Identifier Source: org_study_id