Clinical trial NCT02541344: Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
Official title: Double-blind, Randomised, Placebo-controlled, Three-way Crossover Clinical Investigation to Evaluate the Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prediabetes
Hyperglycemia
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.


Eligibility criteria: Inclusion Criteria:

* Caucasian
* BMI between ≥ 25 and \< 30 kg/m2
* Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
* Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
* Willing to maintain same level of physical activity during the study
* Willing to arrive at the study site with the same, non-strenuous means of transportation during the study
* Negative pregnancy testing (beta hCG) for women of childbearing potential during screening
* Women of child-bearing potential have to agree to use appropriate birth control methods during the study period
* Written informed consent of the subject to participate is a prerequisite for study participation

Exclusion Criteria:

* Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
* Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
* Use of anti-diabetic medication
* Strenuous exercise within one day prior to blood glucose sampling (including screening).
* History of bariatric surgery, small bowel resection, or extensive bowel resection
* Difficult veins
* Recent blood donation in the last 1 month prior to study
* Pregnancy or nursing
* Clinically relevant excursions of safety parameters
* Any other serious condition or disease that renders subjects ineligible
* Smoking
* Exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling
* All vegetarians and subjects with self-reported diet high in fat or protein
* Subjects are not able to communicate with local study staff
* Recent antibiotic and cortisone use up to one week and during the study
* Participation in another study during the last 30 days of the screening visit (V1)

Primary outcomes:
measure: Percentage change in raised postprandial glucose (PPG) AUC levels of the verum groups (dose D1 and dose D2) compared against the placebo among normal to prediabetic overweight Caucasian subjects.
timeFrame: 120 minutes
Secondary outcomes:
measure: Change in incremental PPG AUC level (mmol/L)
timeFrame: 120 minutes
measure: Change in total and incremental PPG AUC level (mmol/L)
timeFrame: 180 minutes
measure: Changes in PPG concentration
timeFrame: 180 minutes
measure: Dose response of PPG level
timeFrame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
measure: Change in total and incremental AUC insulin level (mmol/L)
timeFrame: 180 minutes
measure: Dose response of insulin level
timeFrame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
measure: Change in total and incremental AUC triglyceride level
timeFrame: 180 minutes
measure: Global evaluation of tolerability both by investigator and subjects
timeFrame: Throughout the study (8-14 days)
measure: Incidence of adverse events (Safety parameters evaluation)
timeFrame: Throughout the study period (8-14 days)
measure: Reported adverse events
timeFrame: Throughout the whole study period (8-14 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
Study officials:
affiliation: Charite
name: Ralf Uebelhack, PhD
role: PRINCIPAL_INVESTIGATOR
References: