NCT01590667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

May 1, 2012

Last Update Submit

July 25, 2012

Conditions

Healthy Subjects

Keywords

Fat excretion

Outcome Measures

Primary Outcomes (1)

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

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

    7 days per intervention

Secondary Outcomes (3)

  • Full blood count

    Approximately 45 days

  • Clinical chemistry

    Approximately 45 days

  • Blood pressure

    Approximately 45 days

Study Arms (2)

Litramine

ACTIVE COMPARATOR

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

Device: Litramine

Placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

LitramineDEVICE

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

Litramine
PlaceboDEVICE

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weißenseer Weg 111

Berlin, State of Berlin, 10369, Germany

Location

Related Publications (1)

  • Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW. Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation. Curr Ther Res Clin Exp. 2014 Jun 21;76:39-44. doi: 10.1016/j.curtheres.2014.02.001. eCollection 2014 Dec.

    PMID: 25067985DERIVED

Study Officials

  • Regina Busch, MD

    analyze & realize AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 3, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

DE(1)