Clinical trial NCT02930681: Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia, Postprandial
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. This study is to enrich the existing evidence on dose-dependent post-prandial glucose effects of Glucosanol


Eligibility criteria: 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:

  1. maintain the same level of physical activity during the study, including non-strenuous transportation to the study visits
  2. 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:

  1. negative pregnancy testing (ß-HCG in urine at V1)
  2. 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

Primary outcomes:
measure: Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm
timeFrame: 120 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack, MD
role: PRINCIPAL_INVESTIGATOR
References: