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

Brief Summary:
Safety and Efficacy of Litramine in weight loss.

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

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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


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




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


Information from the National Library of Medicine

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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

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Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT02488356     History of Changes
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:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes