Litramine for Weight Loss

Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study

Safety and Efficacy of Litramine in weight loss.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Litramine

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight from baseline	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: INQP1200