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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014