Litramine for Weight Loss

NCT ID: NCT02488356

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-05-31

Brief Summary

Safety and Efficacy of Litramine in weight loss.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Litramine

Patented fibre complex from Opuntia ficus-indica (Litramine)

Group Type: EXPERIMENTAL

Litramine

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Inert fillers that is manufactured to look and taste the same as verum

Group Type: PLACEBO_COMPARATOR

Litramine

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Litramine

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

IQP G-002AS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

INQP1200

Identifier Type: -

Identifier Source: org_study_id