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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
27
Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
Dose 2 (D2) group will take 4 tablets with active ingredients.
Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102.
analyze & realize GmbH
Berlin, State of Berlin, Germany
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
Time frame: 120 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 180 minutes
Dose response of PPG level
Time frame: 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.
Time frame: 180 minutes
Dose response of insulin level
Time frame: Measured after intake of verum or placebo on recruited subjects on each of the 3 visit days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 180 minutes
Global evaluation of tolerability both by investigator and subjects
Global scaled evaluation with "very good", "good", "moderate" and "poor"
Time frame: Throughout the study (8-14 days)
Incidence of adverse events (Safety parameters evaluation)
Eg. Liver Function Test, Lipid parameters, Renal Function Tests.
Time frame: 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)
Time frame: Throughout the whole study period (8-14 days)