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Completed

NCT Number: NCT01505387

Litramine in Weight Maintenance

The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barbara Grube

Berlin, State of Berlin, 10709, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
  • BMI 25-35 before initial weight loss
  • Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens

Exclusion criteria

  • Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
  • BMI < 18.5
  • Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Treatment and study plan

Litramine

Dietary Supplement

Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)

Placebo

Dietary Supplement

Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)

Primary outcomes

  1. Mean Change in Body Weight From Baseline to End of 24 Weeks

    Time frame: 24 weeks

    Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction

Secondary outcomes

  1. Waist and Hip Circumference (cm)

    Time frame: 24 weeks

    Changes from baseline to end of study

  2. Body Mass Index (kg/m^2)

    Time frame: 24 weeks

    Changes from baseline to end of study

  3. Full Blood Count

    Time frame: 24 weeks

    Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)

  4. Blood Pressure

    Time frame: 24 weeks

    Measured in mm Hg

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
Jun 1, 2015

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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