Litramine for Weight Loss

• ClinicalTrials.gov Identifier: NCT02488356
• Recruitment Status: Completed
• First Posted: July 2, 2015
• Last Update Posted: August 26, 2015
• Sponsor: InQpharm Group
• Information provided by (Responsible Party): InQpharm Group

Tracking Information

• First Submitted Date: June 30, 2015
• First Posted Date: July 2, 2015
• Last Update Posted Date: August 26, 2015
• Study Start Date: September 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 1, 2015): Change in body weight from baseline [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Litramine for Weight Loss
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Weight Loss

Intervention

Dietary Supplement: Litramine

Other Name: IQP G-002AS

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2015): 99
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02488356
• Other Study ID Numbers: INQP1200
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: InQpharm Group
• Original Responsible Party: Same as current
• Current Study Sponsor: InQpharm Group
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: InQpharm Group
• Verification Date: August 2015