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Litramine for Weight Loss

Primary Purpose

Weight Loss

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Litramine

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Litramine

Placebo

Arm Description

Patented fibre complex from Opuntia ficus-indica (Litramine)

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

Outcomes

Primary Outcome Measures

Change in body weight from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT02488356

First Posted

June 30, 2015

Last Updated

August 25, 2015

Sponsor

InQpharm Group

1. Study Identification

Unique Protocol Identification Number

NCT02488356

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InQpharm Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Safety and Efficacy of Litramine in weight loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Litramine

Arm Type

Experimental

Arm Description

Patented fibre complex from Opuntia ficus-indica (Litramine)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Litramine

Other Intervention Name(s)

IQP G-002AS

Primary Outcome Measure Information:

Title

Change in body weight from baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

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Litramine for Weight Loss

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