Weight MaintenancePhase 4NCT01505387
Litramine in Weight Maintenance
A Phase 4 study testing Litramine in people with Weight Maintenance and Overweight, run by InQpharm Group at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Maintenance, Overweight, Obese
- What is being tested?
- Litramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Weight Maintenance, Overweight, Obese
- Being tested
- Litramine, Placebo
- Keywords
- Weight maintenance, Overweight, Obese, Weight management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitramineDietary supplement
Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
PlaceboDietary supplement
Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Receives: Dietary Supplement: Placebo |
| Litramine | Experimental | Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal) Receives: Dietary Supplement: Litramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Body Weight From Baseline to End of 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
Measured: 24 weeks
Secondary outcomes (4)
Waist and Hip Circumference (cm)
Changes from baseline to end of study
Measured: 24 weeks
Body Mass Index (kg/m^2)
Changes from baseline to end of study
Measured: 24 weeks
Full Blood Count
Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)
Measured: 24 weeks
Blood Pressure
Measured in mm Hg
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight MaintenanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505387
- Sponsor's protocol ID
- INQ/024511
- Status last verified
- May 2015
- First submitted
- 4 Jan 2012
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grube B, Chong PW, Alt F, Uebelhack R. Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study. J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7.
PubMed 26435849
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01505387
- Acronym / sponsor ID
- INQ/024511
- Conditions
- Weight Maintenance, Overweight, Obese
- Keywords
- Weight maintenance, Overweight, Obese, Weight management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Posted 3 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical to Litramine 2 tablets 3 times daily (oral consumption, after meal) |
| Litramine | Experimental | Dietary Supplement: LitramineFibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| LitramineFibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) | Dietary supplement | Litramine |
| PlaceboIdentical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Waist and Hip Circumference (cm)
Time frame: 24 weeks
Body Mass Index (kg/m^2)
Time frame: 24 weeks
Full Blood Count
Time frame: 24 weeks
Blood Pressure
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26435849Grube B, Chong PW, Alt F, Uebelhack R. Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study. J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weight Maintenance and Overweight, 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 3 inclusion and 3 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 1 Jun 2015. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Body Weight From Baseline to End of 24 Weeks (time frame: 24 weeks). 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 NCT01505387, 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 1 Jun 2015.