Overweight and ObesityPhase 4NCT01407393
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
A Phase 4 study testing Glucosanol in people with Overweight and Obesity, run by InQpharm Group at 1 site in Germany.
Trial summary
Glucosanol™, the medical device to be investigated contains a proprietary plant extract that is a natural inhibitor of alpha-amylase and can reduce starch digestion. The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Glucosanol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Dec 2011
- 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
- Age 18 to 60 years
- BMI between 25 and 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
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- 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
- History of Diabetes mellitus
- Fasting blood glucose >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
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- Presence of acute or chronic gastrointestinal disease (e.g., IBD, coeliac disease. pancreatitis)
- Uncontrolled hypertension (>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 such as 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 antidiarrheals (e.g., loperamide; must have stopped 1 months before study start)
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity
- 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
- Participation in similar studies or weight loss programs within 3 months prior to enrolment
- Participation in other studies within 4 weeks prior to enrollment
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 Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Glucosanol™, the medical device to be investigated contains a proprietary plant extract that is a natural inhibitor of alpha-amylase and can reduce starch digestion.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
Read the detailed description
Preparations that reduce absorption of calories from dietary carbohydrates could be decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be used as a tool for the treatment of obesity and weight management through reduced carbohydrate absorption.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
The specific hypotheses to be accepted or rejected by statistical data from the clinical investigation are beneficial effects of the device on weight loss (kg) and body fat content.
- Conditions
- Overweight and Obesity
- Being tested
- Glucosanol, Placebo
- Keywords
- overweight, obesity, weight loss, body fat, waste cirumference, satiety, appetite
- 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.
GlucosanolDevice
2 tablets 3x daily for 12 weeks
PlaceboDevice
2 tablets 3x daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Glucosanol | Experimental | Glucosanol Receives: Device: Glucosanol |
| Placebo | Placebo comparator | Placebo Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
The primary endpoint of this randomized, double-blind, placebo-controlled bicen-tric study is to assess the weight loss effect of Glucosanol™ (kg), in combination with a weight loss program in overweight and obese subjects.
Measured: 12 weeks
Secondary outcomes (10)
Proportion body weight
To assess the efficacy of Glucosanol™ to increase the proportions of subjects who lose at least 3% and 5% of baseline body weight
Measured: 12 weeks
waist circumference
Changes in waist circumference
Measured: 12 weeks
hip circumference
Changes in hip circumference
Measured: 12 weeks
waist-hip-ratio
Changes in waist-hip-ratio
Measured: 12 weeks
BMI
Changes in BMI
Measured: 12 weeks
body fat
Changes in body fat (% and kg) and fat free mass (kg)
Measured: 12 weeks
hunger
Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire
Measured: 12 weeks
Global evaluation of feeling of satiety
This parameter will be assessed by a 4 points categorical scale
Measured: 12 weeks
Global evaluation of the efficacy
This parameter will be assessed by a 4 points categorical scale
Measured: 12 weeks
Global evaluation of safety
This will be assessed by both investigators and subjects by a 4 points categorical scale.
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 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 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
- NCT01407393
- Sponsor's protocol ID
- INQ/K/003411
- Status last verified
- Oct 2013
- First submitted
- 30 Jun 2011
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. 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 Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01407393
- Acronym / sponsor ID
- INQ/K/003411
- Conditions
- Overweight and Obesity
- Keywords
- overweight, obesity, weight loss, body fat, waste cirumference, satiety, appetite
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Aug 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.
Glucosanol™, the medical device to be investigated contains a proprietary plant extract that is a natural inhibitor of alpha-amylase and can reduce starch digestion.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
Detailed description
Preparations that reduce absorption of calories from dietary carbohydrates could be decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be used as a tool for the treatment of obesity and weight management through reduced carbohydrate absorption.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
The specific hypotheses to be accepted or rejected by statistical data from the clinical investigation are beneficial effects of the device on weight loss (kg) and body fat content.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosanol | Experimental | Device: GlucosanolGlucosanol |
| Placebo | Placebo comparator | Device: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 60 years
- BMI between 25 and 35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Consistent and stable body weight 3 months prior to study enrolment
Key exclusion criteria (22 listed)
- Known sensitivity to the ingredients of the device
- History of Diabetes mellitus
- Fasting blood glucose >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
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 3x daily for 12 weeks | Device | Glucosanol |
| Placebo2 tablets 3x daily for 12 weeks | Device | Placebo |
Primary outcome
weight loss
Time frame: 12 weeks
The primary endpoint of this randomized, double-blind, placebo-controlled bicen-tric study is to assess the weight loss effect of Glucosanol™ (kg), in combination with a weight loss program in overweight and obese subjects.
10 secondary outcomes
Proportion body weight
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
hip circumference
Time frame: 12 weeks
waist-hip-ratio
Time frame: 12 weeks
BMI
Time frame: 12 weeks
body fat
Time frame: 12 weeks
hunger
Time frame: 12 weeks
Global evaluation of feeling of satiety
Time frame: 12 weeks
Global evaluation of the efficacy
Time frame: 12 weeks
Global evaluation of safety
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 8 Oct 2013.
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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 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 9 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 8 Oct 2013. 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 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?
weight loss (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 8 Oct 2013.