Overweight and ObesityNCT02930668
Efficacy and Safety of Glucosanol™ in Body Weight Reduction
A study testing Glucosanol 350mg and Glucosanol 500mg in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial summary
It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Glucosanol 350mg and Glucosanol 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Nov 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25 kg/m2 - 34,9 kg/m2
- Generally in good health• Desire to lose weight
- Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
- Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)• Readiness to take IP as recommended
- Readiness to avoid the use of other weight loss and/or management products and/or programs during the study
- Readiness to adhere to diet recommendation during the study
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- Readiness to keep the habitual level of physical activity as prior to the study during the study
- Readiness and ability to complete the subject diary and study questionnaires
- Negative pregnancy testing (beta HCG-test in urine) at V1 in women of childbearing potential
- Women of childbearing potential: commitment to use contraception methods
Who cannot join
- Known allergy or hypersensitivity to the components of the investigational products
- Known allergy or hypersensitivity to members of the Fabaceae family
- Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
- Significant disorders:
- untreated or unstable thyroid gland disorder
- untreated or unstable hypertension (>140/90 mm Hg)
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- acute or chronic gastrointestinal (GI) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator)
- Significant surgery within the last 6 months prior to V1:
- GI surgery
- liposuction
- History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1
- Clinically relevant excursions of safety laboratoryparameters
- Any electronic medical implant
- Regular use of anticoagulants
- Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:
- that could influence body weight (e.g. systemic corticosteroids)
- that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement
- for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
- Consumption of food supplements or natural health products for the duration of the study
- Diet to lose and/or manage weight (except ac-cording to the study protocol)
- Vegetarian, vegan or macrobiotic diet
- Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
- Pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Inability to comply with study requirements
- Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
- Participation in another clinical study in the 30 days prior to V1 and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects
It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population.
- Conditions
- Overweight and Obesity
- Being tested
- Glucosanol 350mg, Glucosanol 500mg, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosanol 350mgDietary supplement
Glucosanol 500mgDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose.
Subjects will take 2 capsules three times a day, 30 mins before meals. Receives: Dietary Supplement: Placebo |
| Low dose (Glucosanol 350mg) | Experimental | Each capsule contains Glucosanol / Phaselite 350mg
Subjects will take 2 capsules three times a day, 30 mins before meals. Receives: Dietary Supplement: Glucosanol 350mg |
| High dose (Glucosanol 500mg) | Experimental | Each capsule contains Glucosanol / Phaselite 500mg
Subjects will take 2 capsules three times a day, 30 mins before meals. Receives: Dietary Supplement: Glucosanol 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo
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 posted12 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
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 Overweight and ObesityStudies 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, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, MD, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930668
- Sponsor's protocol ID
- INQ/024115
- Status last verified
- Jul 2023
- First submitted
- 10 Oct 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jager R, Abou Sawan S, Purpura M, Grube B, Roske Y, De Costa P, Chong PW. Proprietary alpha-amylase inhibitor formulation from white kidney bean (Phaseolus vulgaris L.) promotes weight and fat loss: a 12-week, double-blind, placebo-controlled, randomized trial. Sci Rep. 2024 Jun 3;14(1):12685. doi: 10.1038/s41598-024-63443-8.
PubMed 38830962
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects
- ClinicalTrials.gov ID
- NCT02930668
- Acronym / sponsor ID
- INQ/024115
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Oct 2016 (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.
It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose. Subjects will take 2 capsules three times a day, 30 mins before meals. |
| Low dose (Glucosanol 350mg) | Experimental | Dietary Supplement: Glucosanol 350mgEach capsule contains Glucosanol / Phaselite 350mg Subjects will take 2 capsules three times a day, 30 mins before meals. |
| High dose (Glucosanol 500mg) | Experimental | Dietary Supplement: Glucosanol 500mgEach capsule contains Glucosanol / Phaselite 500mg Subjects will take 2 capsules three times a day, 30 mins before meals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- BMI 25 kg/m2 - 34,9 kg/m2
- Generally in good health• Desire to lose weight
- Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
- Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)• Readiness to take IP as recommended
- Readiness to avoid the use of other weight loss and/or management products and/or programs during the study
Key exclusion criteria (28 listed)
- Known allergy or hypersensitivity to the components of the investigational products
- Known allergy or hypersensitivity to members of the Fabaceae family
- Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
- Significant disorders:
- Significant surgery within the last 6 months prior to V1:
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 |
|---|---|---|
| Glucosanol 350mg | Dietary supplement | Low dose (Glucosanol 350mg) |
| Glucosanol 500mg | Dietary supplement | High dose (Glucosanol 500mg) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo
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 27 Jul 2023.
- Derived from this study: PubMed 38830962Jager R, Abou Sawan S, Purpura M, Grube B, Roske Y, De Costa P, Chong PW. Proprietary alpha-amylase inhibitor formulation from white kidney bean (Phaseolus vulgaris L.) promotes weight and fat loss: a 12-week, double-blind, placebo-controlled, randomized trial. Sci Rep. 2024 Jun 3;14(1):12685. doi: 10.1038/s41598-024-63443-8.
- Individual participant dataSharing planned: No
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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.
Ralf Uebelhack, MD principal investigator
analyze & realize GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosanol 350mg and Glucosanol 500mg 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 10 inclusion and 28 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 2023. 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.
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 in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo (time frame: 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 NCT02930668, 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 2023.