Efficacy and Safety of Zenoctil in Reducing Body Weight - Full Text View

Purpose

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.

Condition	Intervention	Phase
Overweight	Dietary Supplement: Zenoctil Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects

Further study details as provided by InQpharm Group:

Primary Outcome Measures:

Difference in mean loss of body weight (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Difference in mean loss of body fat (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who lost at least 3% and 5% of baseline body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in hip circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in waist-hip-ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in body fat content (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Changes in hunger, eating, and food-craving related items from the Control of Eating Questionnaire (COEQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Subjects' global feeling of satiety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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".
Changes in body fat free mass (kg) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global evaluation of safety by investigators [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Global evaluation of safety by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Global evaluation of efficacy by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

Enrollment:	92
Study Start Date:	July 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Zenoctil	Dietary Supplement: Zenoctil 3 tablets 2 times daily
Placebo Comparator: Placebo	Other: Placebo 3 tablets 2 times daily

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423617

Locations

Germany
Barbara Grube
Berlin, Germany

Sponsors and Collaborators

InQpharm Group

Investigators

Principal Investigator:

Barbara Grube, MD

More Information

No publications provided

Responsible Party:	InQpharm Group
ClinicalTrials.gov Identifier:	NCT01423617 History of Changes
Other Study ID Numbers:	INQ/005611
Study First Received:	August 24, 2011
Last Updated:	January 12, 2012
Health Authority:	Germany: Not applicable

Keywords provided by InQpharm Group:

overweight
weight loss
body fat

waist circumference
satiety
appetite

Additional relevant MeSH terms:

Body Weight
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013