Litramine for Weight Loss

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488356
• Other study ID #: INQP1200
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: August 25, 2015
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and Efficacy of Litramine in weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Loss

Intervention

Dietary Supplement:
• Litramine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline		12 weeks	No