Litramine for Weight Loss

NCT02488356 | Completed

• 1 other identifier: INQP1200
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety and Efficacy of Litramine in weight loss.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in body weight from baseline

  12 weeks

Study Arms (2)

Litramine

EXPERIMENTAL

Patented fibre complex from Opuntia ficus-indica (Litramine)

Dietary Supplement: Litramine

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Litramine

Interventions

Litramine DIETARY_SUPPLEMENT

Also known as: IQP G-002AS

Litramine; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• InQpharm Group: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 26, 2015

Record last verified: 2015-08