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

Primary Purpose

Prediabetes, Hyperglycemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dose 1 of IQP-VV-102
Dose 2 of IQP-VV-102
Placebo
Sponsored by
InQpharm Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • analyze & realize GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dose 1 of IQP-VV-102

Dose 2 of IQP-VV-102

Placebo

Arm Description

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.

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.

Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Dose response of PPG level
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.
Dose response of insulin level
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.
Global evaluation of tolerability both by investigator and subjects
Global scaled evaluation with "very good", "good", "moderate" and "poor"
Incidence of adverse events (Safety parameters evaluation)
Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
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)

Full Information

First Posted
August 24, 2015
Last Updated
November 9, 2015
Sponsor
InQpharm Group
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1. Study Identification

Unique Protocol Identification Number
NCT02541344
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Hyperglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 of IQP-VV-102
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dose 2 of IQP-VV-102
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Total 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
Intervention Type
Device
Intervention Name(s)
Dose 1 of IQP-VV-102
Intervention Description
Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
Intervention Type
Device
Intervention Name(s)
Dose 2 of IQP-VV-102
Intervention Description
Dose 2 (D2) group will take 4 tablets with active ingredients.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102.
Primary Outcome Measure Information:
Title
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.
Description
Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Change in incremental PPG AUC level (mmol/L)
Description
Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Time Frame
120 minutes
Title
Change in total and incremental PPG AUC level (mmol/L)
Description
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.
Time Frame
180 minutes
Title
Changes in PPG concentration
Description
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.
Time Frame
180 minutes
Title
Dose response of PPG level
Time Frame
Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Title
Change in total and incremental AUC insulin level (mmol/L)
Description
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.
Time Frame
180 minutes
Title
Dose response of insulin level
Time Frame
Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Title
Change in total and incremental AUC triglyceride level
Description
Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.
Time Frame
180 minutes
Title
Global evaluation of tolerability both by investigator and subjects
Description
Global scaled evaluation with "very good", "good", "moderate" and "poor"
Time Frame
Throughout the study (8-14 days)
Title
Incidence of adverse events (Safety parameters evaluation)
Description
Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
Time Frame
Throughout the study period (8-14 days)
Title
Reported adverse events
Description
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)
Time Frame
Throughout the whole study period (8-14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Uebelhack, PhD
Organizational Affiliation
Charite
Official's Role
Principal Investigator
Facility Information:
Facility Name
analyze & realize GmbH
City
Berlin
ZIP/Postal Code
10369
Country
Germany

12. IPD Sharing Statement

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

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