Safety and Efficacy of Litramine in Overweight and Obese Subjects

Obesity Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233349
• Other study ID #: INQ/K/00310
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2010
• Last updated: October 12, 2011
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2011
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: State Ministry of labor protection, health protection and technical safety Berlin (Landesamt für Arbeitsschutz, Gesundheitsschutz und technische Sicherheit Berlin), Germany:
• Study type: Interventional

Clinical Trial Summary

Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.

Therefore, the rationale for this study is to confirm that Litramineʼs proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 25 = BMI = 35

• Expressed desire for weight loss

• Accustomed to 3 main meals/day

• Consistent and stable body weight 3 months prior to study enrolment

• Commitment to avoid the use of other weight loss products during study

• Commitment to adhere to diet recommendation

• Females' agreement to use appropriate birth control methods during the active study period

• Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

• Known sensitivity to the ingredients of the device

• Presence of any active gastrointestinal disease

• Malabsorption disorders (e.g. Coeliac disease)

• Pancreatitis

• Stenosis in the GI tract

• Bariatric surgery

• Abdominal surgery within the last 6 months prior to the study

• History of eating disorders like bulimia, anorexia nervosa

• History of renal disease

• History of nephrolithiasis

• History of cardiac diseases

• Osteoporosis

• Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus

• Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start)

• Pregnancy or nursing

• Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.)

• More than 3 hours serious sport activity per week

• History of abuse of drugs, alcohol or medication

• Smoking cessation within the 6 months prior to this study

• Inability to comply due to language difficulties

• Participation in similar studies or weight loss programs within the 6 months prior to this study

• Participation in other studies within the last 4 weeks

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Device:
• Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
• Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss (kg)		after 12 weeks	No
Secondary	body fat content and fat free mass		after 12 weeks	No
Secondary	hemogram, clinical chemistry parameter, and lipid profile		after 12 weeks	Yes
Secondary	Proportion of subjects who lost at least 5% and 10% of baseline body weight		after 12 weeks	No
Secondary	Subjects global feeling of satiety		every 4 weeks	No
Secondary	Global evaluation of the incidence of food cravings		every 4 weeks	No
Secondary	Changes in waist circumference (cm)		every 4 weeks	No
Secondary	blood pressure		every 4 weeks	Yes
Secondary	adverse events		every 4 weeks	Yes
Secondary	Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)		after 8 and 12 weeks	Yes
Secondary	Global evaluation of safety/tolerability	by subjects and investigators - based on rating scales	after 12 weeks	Yes