- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02930681
Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects
February 7, 2017 updated by: InQpharm Group
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, D-13467
- analyze & realize GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Four capsules of placebo to be taken 30 mins before each test meal at the investigator's site
|
|
EXPERIMENTAL: Glucosanol 1000mg
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
|
|
EXPERIMENTAL: Glucosanol 2000mg
Four capsules of Glucosanol 500mg to be taken 30 mins before each test meal at the investigator's site
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
120 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
October 10, 2016
First Posted (ESTIMATE)
October 12, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
February 8, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INQ/024515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperglycemia, Postprandial
-
San Diego State UniversityRecruitingPostprandial Hyperglycemia | Postprandial Glycemic Response | Postprandial InsulinUnited States
-
University of LeedsCompletedEffect of Food on Postprandial HyperglycemiaUnited Kingdom
-
San Diego State UniversityCompletedPostprandial Hyperglycemia | Postprandial InsulinUnited States
-
Clinica Universidad de Navarra, Universidad de...CompletedLipid Profile | Hyperglycemia, Postprandial | Feeding Behaviors | Antioxidant | PostprandialSpain
-
Loughborough UniversityUniversity of BedfordshireCompletedPostprandial HyperglycemiaUnited Kingdom
-
Addis Ababa UniversityCompletedHyperglycemia, Postprandial
-
University of Eastern FinlandFinnsugar LtdCompletedHyperglycemia, PostprandialFinland
-
Harokopio UniversityNational and Kapodistrian University of AthensCompleted
-
University of SharjahCompletedPostprandial HyperglycemiaUnited Arab Emirates
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompletedHyperglycemia, PostprandialPortugal
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States