Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Prediabetes
• Intervention / Treatment: Device: Dose 1 of IQP-VV-102; Device: Dose 2 of IQP-VV-102; Device: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • analyze & realize GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dose 1 of IQP-VV-102; Total 4 tablets (2 tablets with active ingredients and 2 placebo tablets) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.	Device: Dose 1 of IQP-VV-102; Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
Active Comparator: Dose 2 of IQP-VV-102; Total 4 tablets (4 tablets with active ingredients) to be taken, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.	Device: Dose 2 of IQP-VV-102; Dose 2 (D2) group will take 4 tablets with active ingredients.
Placebo Comparator: Placebo; Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.	Device: Placebo; Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in incremental PPG AUC level (mmol/L)	Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.	120 minutes
Change in total and incremental PPG AUC level (mmol/L)	Measured from 0th minute, to 60th, 90th and 180th minute after intake of verum or placebo on subjects on each of the 3 visit days.	180 minutes
Changes in PPG concentration	Measured at 15, 30, 45, 60, 90, and 120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.	180 minutes
Dose response of PPG level		Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC insulin level (mmol/L)	Measured from 0th minute to 120th and 180th minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.	180 minutes
Dose response of insulin level		Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Change in total and incremental AUC triglyceride level	Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.	180 minutes
Global evaluation of tolerability both by investigator and subjects	Global scaled evaluation with "very good", "good", "moderate" and "poor"	Throughout the study (8-14 days)
Incidence of adverse events (Safety parameters evaluation)	Eg. Liver Function Test, Lipid parameters, Renal Function Tests.	Throughout the study period (8-14 days)
Reported adverse events	For any adverse event, the term of the event, intensity, duration, seriousness, frequency, outcome and assessment of causality with the investigational product will be documented in the Case Report Form (CRF)	Throughout the whole study period (8-14 days)

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Ralf Uebelhack, PhD, Charité

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperglycemia; Overweight
• Other Study ID Numbers: INQ/024613