Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02930681
• Date of registration: 10/10/2016
• Prospective Registration: No
• Primary sponsor: InQpharm Group
• Public title: Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects
• Scientific 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
• Date of first enrolment: August 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02930681
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Ralf Uebelhack, MD
• Affiliation: analyze & realize GmbH

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperglycemia, Postprandial

Intervention(s)

Dietary Supplement: Glucosanol 500mg

Dietary Supplement: Placebo

Primary Outcome(s)

Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm [Time Frame: 120 mins]

Secondary ID(s)

INQ/024515

Source(s) of Monetary Support

Please refer to primary and secondary sponsors