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Litramine for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02488356
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
InQpharm Group

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 2, 2015
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
Change in body weight from baseline [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Litramine for Weight Loss
Official Title  ICMJE Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study
Brief Summary Safety and Efficacy of Litramine in weight loss.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE Dietary Supplement: Litramine
Other Name: IQP G-002AS
Study Arms  ICMJE
  • Experimental: Litramine
    Patented fibre complex from Opuntia ficus-indica (Litramine)
    Intervention: Dietary Supplement: Litramine
  • Placebo Comparator: Placebo
    Inert fillers that is manufactured to look and taste the same as verum
    Intervention: Dietary Supplement: Litramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2015)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects ≥18 and ≤ 60 years of age
  • Body mass index (BMI) ≥ 25 and ≤35 kg/m2
  • Judged by the Investigator to be in general good health on the basis of medical history
  • Judged by the Investigator to be motivated to lose weight
  • Accustomed to 3 main meals per day
  • Consistent and stable body weight 3 months prior to study enrollment (±5%)
  • Consistent regular physical activity
  • Agree to stop all medications and supplements during the entire length of the study
  • Commitment to adhere to diet and lifestyle recommended for the study
  • Females of child bearing potential must agree to use appropriate birth control methods during the entire study period
  • Stable concomitant medications
  • Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

Exclusion Criteria:

  • Presence of any active gastrointestinal disease

    • Malabsorption disorders
    • Pancreatitis
    • Stenosis in the GI tract
    • Bariatric surgery/Lapband and bypass surgery
    • Abdominal surgery within 6 months prior to the study
  • Subjects whose weight increases 1.5 pounds from screening to the baseline visit
  • History of eating disorders like bulimia, anorexia nervosa, binge-eating
  • Renal conditions / disease, history of nephrolithiasis
  • Cardiac diseases requiring drug therapy
  • Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases
  • Osteoporosis or on medications for osteoporosis
  • Known sensitivity to the ingredients of the study medication
  • Vegetarian or Vegan
  • Daily use of dietary supplement (2 week washout is allowed)
  • Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start)
  • Subjects who are pregnant or lactating
  • Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.)
  • Subjects who are currently on carbohydrate and protein diet, or low fat diet
  • More than 3 hours of strenuous physical activity per week
  • History of abuse of drugs, alcohol or medication
  • Smoking cessation within the 6 months prior to this study
  • Subjects unable to understand or follow the study protocol
  • Participation in similar study or weight loss program within 6 months prior to this study
  • Participation in other studies with in the last 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02488356
Other Study ID Numbers  ICMJE INQP1200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party InQpharm Group
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InQpharm Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InQpharm Group
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP