Efficacy and Safety of Zenoctil in Reducing Body Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01423617
First received: August 24, 2011
Last updated: January 12, 2012
Last verified: January 2012
  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 April 17, 2014