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Completed

NCT Number: NCT01590667

Effect of Litramine on Fat Excretion

The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weißenseer Weg 111

Berlin, State of Berlin, 10369, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 20-30 kg/m2
  • Accustomed to 3 main meals/day
  • Commitment to avoid the use of other weight management products during study
  • Females' agreement to use appropriate birth control methods during the active study period
  • Self-reported regular bowel movement (1-2 times per day)
  • 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
  • Diabetes mellitus (type 1 or 2)
  • History or clinical signs of endocrine disorders
  • Clinically relevant excursions of safety parameter
  • Current use of anti-depressants
  • Presence of acute or chronic gastrointestinal disease
  • Uncontrolled hypertension (more than 160/110 mm Hg)
  • Stenosis in the gastrointestinal tract
  • Bariatric surgery
  • Abdominal surgery within the last 6 months prior to enrollment
  • History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
  • Other serious organ or systemic diseases such as cancer
  • Any medication that could influence gastrointestinal functions
  • Pregnancy or nursing
  • Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment
  • History of abuse of drugs, alcohol or medication
  • Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation

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. Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention

    Time frame: 7 days per intervention

    The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA)

Secondary outcomes

  1. Full blood count

    Time frame: Approximately 45 days

    Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes

  2. Clinical chemistry

    Time frame: Approximately 45 days

    Liver function, renal function, protein metabolism, lipid metabolism

  3. Blood pressure

    Time frame: Approximately 45 days

    Sitting blood pressure and heart rate will be measured using standard devices

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 3, 2012
Registry last updated
Jul 27, 2012

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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