Healthy SubjectsPhase 4NCT01590667
Effect of Litramine on Fat Excretion
A Phase 4 study testing Litramine in people with Healthy Subjects, run by InQpharm Group at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Litramine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects
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.
- Conditions
- Healthy Subjects
- Being tested
- Litramine, Placebo
- Keywords
- Fat excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitramineDevice
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
PlaceboDevice
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
| Study group | Role | What they receive |
|---|---|---|
| Litramine | Active comparator | 2 tablets 3 times daily (oral consumption, 30 minutes after meal) Receives: Device: Litramine |
| Placebo | Placebo comparator | 2 tablets 3 times daily (oral consumption, 30 minutes after meal) Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days per intervention
Secondary outcomes (3)
Full blood count
Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes
Measured: Approximately 45 days
Clinical chemistry
Liver function, renal function, protein metabolism, lipid metabolism
Measured: Approximately 45 days
Blood pressure
Sitting blood pressure and heart rate will be measured using standard devices
Measured: Approximately 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Regina Busch, MD, Principal investigator, analyze & realize AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590667
- Sponsor's protocol ID
- INQ/028711
- Status last verified
- Jul 2012
- First submitted
- 1 May 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25067985
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01590667
- Acronym / sponsor ID
- INQ/028711
- Conditions
- Healthy Subjects
- Keywords
- Fat excretion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Litramine | Active comparator | Device: Litramine2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
| Placebo | Placebo comparator | Device: Placebo2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Litramine2 tablets 3 times daily (oral consumption, 30 minutes after meal) | Device | Litramine |
| Placebo2 tablets 3 times daily (oral consumption, 30 minutes after meal) | Device | Placebo |
Primary outcome
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)
3 secondary outcomes
Full blood count
Time frame: Approximately 45 days
Clinical chemistry
Time frame: Approximately 45 days
Blood pressure
Time frame: Approximately 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Derived from this study: PubMed 25067985Uebelhack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Busch, MD principal investigator
analyze & realize AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Litramine in people with Healthy Subjects, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention (time frame: 7 days per intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.