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Completed

NCT Number: NCT02541344

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

analyze & realize GmbH

Berlin, State of Berlin, 10369, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dose 1 of IQP-VV-102

Device

Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.

Dose 2 of IQP-VV-102

Device

Dose 2 (D2) group will take 4 tablets with active ingredients.

PLACEBO

Device

Placebo group will take 4 placebo tablets.

The placebo is designed to be identical to IQP-VV-102.

Primary outcomes

  1. 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.

    Time frame: 120 minutes

    Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit

Secondary outcomes

  1. Change in incremental PPG AUC level (mmol/L)

    Time frame: 120 minutes

    Measured from 0-120 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.

  2. Change in total and incremental PPG AUC level (mmol/L)

    Time frame: 180 minutes

    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.

  3. Changes in PPG concentration

    Time frame: 180 minutes

    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.

  4. Dose response of PPG level

    Time frame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.

  5. Change in total and incremental AUC insulin level (mmol/L)

    Time frame: 180 minutes

    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.

  6. Dose response of insulin level

    Time frame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.

  7. Change in total and incremental AUC triglyceride level

    Time frame: 180 minutes

    Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days.

  8. Global evaluation of tolerability both by investigator and subjects

    Time frame: Throughout the study (8-14 days)

    Global scaled evaluation with "very good", "good", "moderate" and "poor"

  9. Incidence of adverse events (Safety parameters evaluation)

    Time frame: Throughout the study period (8-14 days)

    Eg. Liver Function Test, Lipid parameters, Renal Function Tests.

  10. Reported adverse events

    Time frame: Throughout the whole study period (8-14 days)

    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)

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
First posted
Sep 4, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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