Litramine for Weight Loss

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Litramine

• Registration Number: NCT02488356
• Lead Sponsor: InQpharm Group

Brief Summary

Safety and Efficacy of Litramine in weight loss.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Litramine	Inert fillers that is manufactured to look and taste the same as verum
Litramine	Litramine	Patented fibre complex from Opuntia ficus-indica (Litramine)

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline	12 weeks