Hyperglycemia, PostprandialNCT02930681
Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects
A study testing Glucosanol 500mg in people with Hyperglycemia, Postprandial, run by InQpharm Group at 1 site in Germany.
Trial summary
Glucosanol had previously been proven to be effective in aiding weight loss and weight loss maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was effective in aiding weight loss and also has evidence on reducing post-prandial glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial
- What is being tested?
- Glucosanol 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Aug 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
- Caucasian males and females, 18 to 65 years old
- Body mass index (BMI) 25.0-29.9 kg/m2
- Generally in good health
- Normal fasting blood glucose (FBG) 3.9- <5.6 mmol/L (70- <100 mg/dL) and glycated hemoglobin HbA1c of 4- <5.7 %
- Readiness to adhere to consumption of test meals and defined restrictions prior to test meals (refer to section 11.8 for details)
- Readiness to adhere to habitual lifestyle during the study, in particular to:
Show all 15Show fewer
- maintain the same level of physical activity during the study, including non-strenuous transportation to the study visits
- if smoking, regular smoking at the same level as prior
- to the study and no smoking on days of test meals
- prior and during the visit
- Stable body weight in the last 3 months prior to V1 (≤5% self-reported change)
- Stable concomitant medications (if any) for at least last 3 months prior to V1
- Women of child-bearing potential only:
- negative pregnancy testing (ß-HCG in urine at V1)
- commitment to use reliable contraception methods
Who cannot join
- Known sensitivity to any ingredients / excipients of the IP
- Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
- Clinically relevant excursions of safety parameters
- Digestion/absorption disorders in gastrointestinal (GI) tract (e.g. inflammatory bowel disease)
- Uncontrolled hypertension >140/90 mmHg at V1
- Uncontrolled thyroid disorder at V1
Show all 20Show fewer
- Any serious condition or disease that renders subjects ineligible
- Change in daily dose of any treatment and/or use of supplements with a possible impact on glycemic control in the last 3 months prior to V1 and throughout the study (refer to section 10 for details)
- Use of any anti-diabetic treatment or use of treatment and/or supplementation, for reduction of blood glucose levels within the last 4 weeks before V1 and throughout the study
- Use of medications or dietary supplements that may influence body weight ≤4 weeks and gastrointestinal functions ≤2 weeks prior to V1 and during the study
- Antibiotic and cortisone therapy ≤2 weeks prior to V1 and during the study
- Vegetarians and subjects with self-reported diet high in fat or protein
- Strenuous exercise within one day prior to each blood glucose sampling (including V1)
- History of bariatric surgery, small bowel resection or extensive bowel resection
- Recent blood donation within ≤1 month prior to study
- Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) and any alcohol consumption within 24 h before blood glucose sampling
- Inability to comply with study procedures
- Pregnancy or nursing
- Participation in another study during the last 30 days of the screening visit (V1)
- Any other reason deemed suitable for exclusion, per investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Placebo-controlled, 3-way Cross-over Study to Evaluate the Benefit of Two Glucosanol™ Dosages to Reduce Post-prandial Glucose Levels in Overweight Subjects
Glucosanol had previously been proven to be effective in aiding weight loss and weight loss maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was effective in aiding weight loss and also has evidence on reducing post-prandial glucose levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose effects of Glucosanol
- Conditions
- Hyperglycemia, Postprandial
- Being tested
- Glucosanol 500mg, Placebo
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosanol 500mgDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Four capsules of placebo to be taken 30 mins before each test meal at the investigator's site Receives: Dietary Supplement: Placebo |
| Glucosanol 1000mg | Experimental | Two capsules of placebo and two capsules of Glucosanol 500mg capsules to be taken 30 mins before each test meal at the investigator's site Receives: Dietary Supplement: Glucosanol 500mg; Dietary Supplement: Placebo |
| Glucosanol 2000mg | Experimental | Four capsules of Glucosanol 500mg to be taken 30 mins before each test meal at the investigator's site Receives: Dietary Supplement: Glucosanol 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm
Change defined as incremental AUC0 - AUC120min in mmol/(L*min)
Measured: 120 mins
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 startAug 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.
- Other trials for Hyperglycemia, PostprandialStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 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
- NCT02930681
- Sponsor's protocol ID
- INQ/024515
- Status last verified
- Feb 2017
- First submitted
- 10 Oct 2016
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, 3-way Cross-over Study to Evaluate the Benefit of Two Glucosanol™ Dosages to Reduce Post-prandial Glucose Levels in Overweight Subjects
- ClinicalTrials.gov ID
- NCT02930681
- Acronym / sponsor ID
- INQ/024515
- Conditions
- Hyperglycemia, Postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 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.
Glucosanol had previously been proven to be effective in aiding weight loss and weight loss maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was effective in aiding weight loss and also has evidence on reducing post-prandial glucose levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose effects of Glucosanol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFour capsules of placebo to be taken 30 mins before each test meal at the investigator's site |
| Glucosanol 1000mg | Experimental | Dietary Supplement: Glucosanol 500mg, Dietary Supplement: PlaceboTwo capsules of placebo and two capsules of Glucosanol 500mg capsules to be taken 30 mins before each test meal at the investigator's site |
| Glucosanol 2000mg | Experimental | Dietary Supplement: Glucosanol 500mgFour capsules of Glucosanol 500mg to be taken 30 mins before each test meal at the investigator's site |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Caucasian males and females, 18 to 65 years old
- Body mass index (BMI) 25.0-29.9 kg/m2
- Generally in good health
- Normal fasting blood glucose (FBG) 3.9- <5.6 mmol/L (70- <100 mg/dL) and glycated hemoglobin HbA1c of 4- <5.7 %
- Readiness to adhere to consumption of test meals and defined restrictions prior to test meals (refer to section 11.8 for details)
Key exclusion criteria (20 listed)
- Known sensitivity to any ingredients / excipients of the IP
- Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
- Clinically relevant excursions of safety parameters
- Digestion/absorption disorders in gastrointestinal (GI) tract (e.g. inflammatory bowel disease)
- Uncontrolled hypertension >140/90 mmHg at 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 500mg | Dietary supplement | Glucosanol 1000mg, Glucosanol 2000mg |
| Placebo | Dietary supplement | Glucosanol 1000mg, Placebo |
Primary outcome
Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm
Time frame: 120 mins
Change defined as incremental AUC0 - AUC120min in mmol/(L*min)
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 8 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia, Postprandial
Active, not recruiting
How Fig Polyphenols Affect Blood Sugar and Insulin Levels After Eating in Adults at Risk for Diabetes
Pre Diabetic
Enrolling by invitation
Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats
Postprandial Hyperglycemia, Type 2 Diabetes
Active, not recruiting
Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults
Postprandial Hyperglycemia, Hyperinsulinemia
Recruiting
Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring
Postprandial Glucose, Glucose Levels
Not yet recruiting
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (Prediabetes)
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 500mg in people with Hyperglycemia, Postprandial, 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 15 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 8 Feb 2017. 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?
Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm (time frame: 120 mins). 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 8 Feb 2017.