We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Safety and Efficacy of Litramine in weight loss.

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Litramine Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study
Study Start Date : September 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Litramine
Patented fibre complex from Opuntia ficus-indica (Litramine)
 Dietary Supplement: Litramine
Other Name: IQP G-002AS
Placebo Comparator: Placebo
Inert fillers that is manufactured to look and taste the same as verum
 Dietary Supplement: Litramine
Other Name: IQP G-002AS


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in body weight from baseline [ Time Frame: 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT02488356    
Other Study ID Numbers: INQP1200
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Loss
Body Weight Changes