OverweightPhase 4NCT01435278
Efficacy and Safety of Glucosanol in Maintaining Body Weight
A Phase 4 study testing Glucosanol in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial summary
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese… 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
- What is being tested?
- Glucosanol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to 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
- Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
- Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
- BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
- Expressed desire for weight maintenance
- Accustomed to 3 main meals per day
- Commitment to avoid the use of other weight loss products during study
- 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 (Phaseolus vulgaris or members of the Fabaceae family)
- History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
- History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- Clinically relevant excursions of safety parameter
- Current use of anti-depressants
- Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
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- Uncontrolled hypertension (more than 160/110 mm Hg)
- Stenosis in the GI tract
- Bariatric surgery
- Abdominal surgery within the last 6 months prior to enrollment
- History of eating disorders like bulimia, anorexia nervosa within the past 12 months
- Other serious organ or systemic diseases such as cancer
- Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
- More than 3 hours strenuous sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within 6 months prior to enrolment
- Inability to comply due to language difficulties
- 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: Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
- Conditions
- Overweight, Obesity
- Being tested
- Glucosanol
- Keywords
- Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucosanolDevice
2 tablets taken 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Glucosanol | Active comparator | 2 tablets 3 times a day Receives: Device: Glucosanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured in kg using a calibrated scale
Measured: 24 weeks
Secondary outcomes (12)
Waist and hip circumference (cm)
Changes from baseline to end of study
Measured: 24 weeks
Body mass index, BMI (kg/m2)
Changes from baseline to end of study
Measured: 24 weeks
Body fat content and fat free mass
Changes from baseline to end of study
Measured: 24 weeks
Effect on appetite, hunger and food cravings
The Control of Eating Questionnaire (COEQ) is used
Measured: 24 weeks
Feeling of satiety
A 4-point categorical scale is used
Measured: 24 weeks
Evaluation of the efficacy of Glucosanol by the subjects
A 4-point categorical scale is used
Measured: 24 weeks
Full blood count
Done at baseline and end of study
Measured: 24 weeks
Clinical chemistry parameter
Done at baseline and end of study
Measured: 24 weeks
Blood pressure
Measured in mm Hg
Measured: 24 weeks
Global evaluation of the safety of Glucosanol by the subjects
A 4-point categorical scale is used.
Measured: 24 weeks
Global evaluation of the safety of Glucosanol by the investigators
A 4-point categorical scale is used
Measured: 24 weeks
Occurrence of adverse events
All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms
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 posted16 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT01435278
- Sponsor's protocol ID
- INQ/017011
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2011
- Last updated
- 27 Jul 2012
- 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 24006357
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
- Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01435278
- Acronym / sponsor ID
- INQ/017011
- Conditions
- Overweight, Obesity
- Keywords
- Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Sep 2011 (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.
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucosanol | Active comparator | Device: Glucosanol2 tablets 3 times a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
- Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
- BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
- Expressed desire for weight maintenance
- Accustomed to 3 main meals per day
Key exclusion criteria (20 listed)
- Known sensitivity to the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
- History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
- History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland 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 |
|---|---|---|
| Glucosanol2 tablets taken 3 times a day. | Device | Glucosanol |
Primary outcome
Body weight
Time frame: 24 weeks
Measured in kg using a calibrated scale
12 secondary outcomes
Waist and hip circumference (cm)
Time frame: 24 weeks
Body mass index, BMI (kg/m2)
Time frame: 24 weeks
Body fat content and fat free mass
Time frame: 24 weeks
Effect on appetite, hunger and food cravings
Time frame: 24 weeks
Feeling of satiety
Time frame: 24 weeks
Evaluation of the efficacy of Glucosanol by the subjects
Time frame: 24 weeks
Full blood count
Time frame: 24 weeks
Clinical chemistry parameter
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Global evaluation of the safety of Glucosanol by the subjects
Time frame: 24 weeks
Global evaluation of the safety of Glucosanol by the investigators
Time frame: 24 weeks
Occurrence of adverse events
Time frame: 24 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 27 Jul 2012.
- 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.
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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 Glucosanol 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 20 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. 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?
Body weight (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 NCT01435278, 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.