Clinical trial NCT02488356: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Litramine in weight loss.


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

Primary outcomes:
measure: Change in body weight from baseline
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: