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

NCT02930681 | Completed

• 1 other identifier: INQ/024515
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperglycemia, Postprandial

Outcome Measures

Primary Outcomes (1)

• 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)

  120 mins

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Four capsules of placebo to be taken 30 mins before each test meal at the investigator's site

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

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

Dietary Supplement: Glucosanol 500mg

Interventions

Glucosanol 500mg DIETARY_SUPPLEMENT

Glucosanol 1000mg; Glucosanol 2000mg

Placebo DIETARY_SUPPLEMENT

Glucosanol 1000mg; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

analyze & realize GmbH

Berlin, State of Berlin, D-13467, Germany

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ralf Uebelhack, MD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)