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Completed

NCT Number: NCT01233349

Safety and Efficacy of Litramine in Overweight and Obese Subjects

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 Litramine's 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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barbara Grube

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Litramine

Device

2 tablets 3 times daily (oral consumption, 30 minutes after meal)

PLACEBO

Device

2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Primary outcomes

  1. weight loss (kg)

    Time frame: after 12 weeks

Secondary outcomes

  1. body fat content and fat free mass

    Time frame: after 12 weeks

  2. hemogram, clinical chemistry parameter, and lipid profile

    Time frame: after 12 weeks

  3. Proportion of subjects who lost at least 5% and 10% of baseline body weight

    Time frame: after 12 weeks

  4. Subjects global feeling of satiety

    Time frame: every 4 weeks

  5. Global evaluation of the incidence of food cravings

    Time frame: every 4 weeks

  6. Changes in waist circumference (cm)

    Time frame: every 4 weeks

  7. blood pressure

    Time frame: every 4 weeks

  8. adverse events

    Time frame: every 4 weeks

  9. Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)

    Time frame: after 8 and 12 weeks

  10. Global evaluation of safety/tolerability

    Time frame: after 12 weeks

    by subjects and investigators - based on rating scales

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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