OverweightPhase 3NCT01233349
Safety and Efficacy of Litramine in Overweight and Obese Subjects
A Phase 3 study testing Litramine in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial summary
Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Weight Loss
- 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
- 125 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Jan 2011
- Phase
- Phase 3
- 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
- 25 ≤ BMI ≤ 35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Consistent and stable body weight 3 months prior to study enrolment
- Commitment to avoid the use of other weight loss products during study
- Commitment to adhere to diet recommendation
- Females' agreement to use appropriate birth control methods during the active study period
- 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
- Presence of any active gastrointestinal disease
- Malabsorption disorders (e.g. Coeliac disease)
- Pancreatitis
- Stenosis in the GI tract
- Bariatric surgery
Show all 22Show fewer
- Abdominal surgery within the last 6 months prior to the study
- History of eating disorders like bulimia, anorexia nervosa
- History of renal disease
- History of nephrolithiasis
- History of cardiac diseases
- Osteoporosis
- Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus
- Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start)
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.)
- More than 3 hours serious sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within the 6 months prior to this study
- Inability to comply due to language difficulties
- Participation in similar studies or weight loss programs within the 6 months prior to this study
- Participation in other studies within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects
Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.
Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.
- Conditions
- Overweight, Obesity, Weight Loss
- Being tested
- Litramine, Placebo
- Keywords
- overweight, obesity, weight loss, body fat, waist circumference, satiety
- Medical subject headings
- Overweight, Obesity, Weight Loss
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 | Experimental | Not described Receives: Device: Litramine |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss (kg)
Measured: after 12 weeks
Secondary outcomes (10)
body fat content and fat free mass
Measured: after 12 weeks
hemogram, clinical chemistry parameter, and lipid profile
Measured: after 12 weeks
Proportion of subjects who lost at least 5% and 10% of baseline body weight
Measured: after 12 weeks
Subjects global feeling of satiety
Measured: every 4 weeks
Global evaluation of the incidence of food cravings
Measured: every 4 weeks
Changes in waist circumference (cm)
Measured: every 4 weeks
blood pressure
Measured: every 4 weeks
adverse events
Measured: every 4 weeks
Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)
Measured: after 8 and 12 weeks
Global evaluation of safety/tolerability
by subjects and investigators - based on rating scales
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Grube, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233349
- Sponsor's protocol ID
- INQ/K/00310
- Status last verified
- Oct 2011
- First submitted
- 2 Nov 2010
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.
PubMed 24006357Grube B, Chong PW, Lau KZ, Orzechowski HD. A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study. Obesity (Silver Spring). 2013 Jan;21(1):58-64. doi: 10.1002/oby.20244.
PubMed 23505169
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01233349
- Acronym / sponsor ID
- INQ/K/00310
- Conditions
- Overweight, Obesity, Weight Loss
- Keywords
- overweight, obesity, weight loss, body fat, waist circumference, satiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Nov 2010 (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.
Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.
Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.
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 | Device: Litramine |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 25 ≤ BMI ≤ 35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Consistent and stable body weight 3 months prior to study enrolment
- Commitment to avoid the use of other weight loss products during study
Key exclusion criteria (22 listed)
- Known sensitivity to the ingredients of the device
- Presence of any active gastrointestinal disease
- Malabsorption disorders (e.g. Coeliac disease)
- Pancreatitis
- Stenosis in the GI tract
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
weight loss (kg)
Time frame: after 12 weeks
10 secondary outcomes
body fat content and fat free mass
Time frame: after 12 weeks
hemogram, clinical chemistry parameter, and lipid profile
Time frame: after 12 weeks
Proportion of subjects who lost at least 5% and 10% of baseline body weight
Time frame: after 12 weeks
Subjects global feeling of satiety
Time frame: every 4 weeks
Global evaluation of the incidence of food cravings
Time frame: every 4 weeks
Changes in waist circumference (cm)
Time frame: every 4 weeks
blood pressure
Time frame: every 4 weeks
adverse events
Time frame: every 4 weeks
Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)
Time frame: after 8 and 12 weeks
Global evaluation of safety/tolerability
Time frame: after 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 13 Oct 2011.
- Derived from this study: PubMed 24006357Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.
- Derived from this study: PubMed 23505169Grube B, Chong PW, Lau KZ, Orzechowski HD. A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study. Obesity (Silver Spring). 2013 Jan;21(1):58-64. doi: 10.1002/oby.20244.
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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.
Barbara Grube, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Litramine in people with Overweight and Obesity, 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 8 inclusion and 22 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 13 Oct 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
weight loss (kg) (time frame: after 12 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 NCT01233349, which also lists 2 linked publications.
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 13 Oct 2011.