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Efficacy and Safety of Zenoctil in Reducing Body Weight

Primary Purpose

Overweight

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Zenoctil
Placebo
Sponsored by
InQpharm Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, weight loss, body fat, waist circumference, satiety, appetite

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barbara Grube

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zenoctil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Mean Body Weight (kg)
Change in mean body weight at week 12 compared to baseline.
Change in Mean Body Fat (kg)
Change in mean body fat at week 12 compared to baseline

Secondary Outcome Measures

Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Changes in Waist Circumference (cm)
Changes in Hip Circumference
Changes in Waist-hip-ratio
Changes in Body Fat Content (%)
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
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".
Changes in Body Fat Free Mass (kg)
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".
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".
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".

Full Information

First Posted
August 24, 2011
Last Updated
April 5, 2015
Sponsor
InQpharm Group
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1. Study Identification

Unique Protocol Identification Number
NCT01423617
Brief Title
Efficacy and Safety of Zenoctil in Reducing Body Weight
Official Title
Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
overweight, weight loss, body fat, waist circumference, satiety, appetite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zenoctil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Zenoctil
Intervention Description
3 tablets 2 times daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 tablets 2 times daily
Primary Outcome Measure Information:
Title
Change in Mean Body Weight (kg)
Description
Change in mean body weight at week 12 compared to baseline.
Time Frame
12 weeks
Title
Change in Mean Body Fat (kg)
Description
Change in mean body fat at week 12 compared to baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects Who Lost at Least 3% of Baseline Body Weight
Time Frame
12 weeks
Title
Changes in Waist Circumference (cm)
Time Frame
12 weeks
Title
Changes in Hip Circumference
Time Frame
12 weeks
Title
Changes in Waist-hip-ratio
Time Frame
12 weeks
Title
Changes in Body Fat Content (%)
Time Frame
12 weeks
Title
Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)
Time Frame
12 weeks
Title
Subjects' Global Feeling of Satiety
Description
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".
Time Frame
12 weeks
Title
Changes in Body Fat Free Mass (kg)
Time Frame
12 weeks
Title
Global Evaluation of Safety by Investigators
Description
The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Time Frame
12 weeks
Title
Global Evaluation of Safety by Subjects
Description
The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Time Frame
12 weeks
Title
Global Evaluation of Efficacy by Subjects
Description
The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Grube, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Grube
City
Berlin
Country
Germany

12. IPD Sharing Statement

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Efficacy and Safety of Zenoctil in Reducing Body Weight

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