Weight LossNCT02488356
Litramine for Weight Loss
A study testing Litramine in people with Weight Loss, run by InQpharm Group.
Trial summary
Safety and Efficacy of Litramine in weight loss. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Litramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to May 2013
- Phase
- Interventional
- 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
- Healthy subjects ≥18 and ≤ 60 years of age
- Body mass index (BMI) ≥ 25 and ≤35 kg/m2
- Judged by the Investigator to be in general good health on the basis of medical history
- Judged by the Investigator to be motivated to lose weight
- Accustomed to 3 main meals per day
- Consistent and stable body weight 3 months prior to study enrollment (±5%)
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- Consistent regular physical activity
- Agree to stop all medications and supplements during the entire length of the study
- Commitment to adhere to diet and lifestyle recommended for the study
- Females of child bearing potential must agree to use appropriate birth control methods during the entire study period
- Stable concomitant medications
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
Who cannot join
- Presence of any active gastrointestinal disease
- Malabsorption disorders
- Pancreatitis
- Stenosis in the GI tract
- Bariatric surgery/Lapband and bypass surgery
- Abdominal surgery within 6 months prior to the study
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- Subjects whose weight increases 1.5 pounds from screening to the baseline visit
- History of eating disorders like bulimia, anorexia nervosa, binge-eating
- Renal conditions / disease, history of nephrolithiasis
- Cardiac diseases requiring drug therapy
- Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases
- Osteoporosis or on medications for osteoporosis
- Known sensitivity to the ingredients of the study medication
- Vegetarian or Vegan
- Daily use of dietary supplement (2 week washout is allowed)
- Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start)
- Subjects who are pregnant or lactating
- Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.)
- Subjects who are currently on carbohydrate and protein diet, or low fat diet
- More than 3 hours of strenuous physical activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within the 6 months prior to this study
- Subjects unable to understand or follow the study protocol
- Participation in similar study or weight loss program within 6 months prior to this study
- Participation in other studies with in the last 4 weeks
About this study
Official title: Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study
Safety and Efficacy of Litramine in weight loss.
- Conditions
- Weight Loss
- Being tested
- Litramine
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitramineDietary supplement
Also called IQP G-002AS
| Study group | Role | What they receive |
|---|---|---|
| Litramine | Experimental | Patented fibre complex from Opuntia ficus-indica (Litramine) Receives: Dietary Supplement: Litramine |
| Placebo | Placebo comparator | Inert fillers that is manufactured to look and taste the same as verum Receives: Dietary Supplement: Litramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 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
- NCT02488356
- Sponsor's protocol ID
- INQP1200
- Status last verified
- Aug 2015
- First submitted
- 30 Jun 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT02488356
- Acronym / sponsor ID
- INQP1200
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Jul 2015 (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.
Safety and Efficacy of Litramine in weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Litramine | Experimental | Dietary Supplement: LitraminePatented fibre complex from Opuntia ficus-indica (Litramine) |
| Placebo | Placebo comparator | Dietary Supplement: LitramineInert fillers that is manufactured to look and taste the same as verum |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy subjects ≥18 and ≤ 60 years of age
- Body mass index (BMI) ≥ 25 and ≤35 kg/m2
- Judged by the Investigator to be in general good health on the basis of medical history
- Judged by the Investigator to be motivated to lose weight
- Accustomed to 3 main meals per day
Key exclusion criteria (25 listed)
- Presence of any active gastrointestinal disease
- Subjects whose weight increases 1.5 pounds from screening to the baseline visit
- History of eating disorders like bulimia, anorexia nervosa, binge-eating
- Renal conditions / disease, history of nephrolithiasis
- Cardiac diseases requiring drug therapy
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 |
|---|---|---|
| LitramineAlso: IQP G-002AS | Dietary supplement | Litramine, Placebo |
Primary outcome
Change in body weight from baseline
Time frame: 12 weeks
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 26 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Litramine in people with Weight Loss, run by InQpharm Group.
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 12 inclusion and 25 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Change in body weight from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2015; AzTrials last refreshed its copy on 1 Nov 2026.