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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prediabetes, Hyperglycemia

Intervention / Treatment
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* Device: Dose 1 of IQP-VV-102
* Device: Dose 2 of IQP-VV-102
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |