Hyperglycemia, Prediabetes
Conditions
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.
Interventions
DEVICEDose 1 of IQP-VV-102
Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
DEVICEDose 2 of IQP-VV-102
Dose 2 (D2) group will take 4 tablets with active ingredients.
DEVICEPlacebo
Placebo group will take 4 placebo tablets. The placebo is designed to be identical to IQP-VV-102.
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 120 minutes | Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in incremental PPG AUC level (mmol/L) | 120 minutes | 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) | 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. |
| Changes in PPG concentration | 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. |
| Dose response of PPG level | Measured 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 | Throughout the study (8-14 days) | Global scaled evaluation with very good, good, moderate and poor |
| 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 | 180 minutes | Measured from 0-180 minutes after intake of verum or placebo on recruited subjects on each of the 3 visit days. |
| Incidence of adverse events (Safety parameters evaluation) | Throughout the study period (8-14 days) | Eg. Liver Function Test, Lipid parameters, Renal Function Tests. |
| Reported adverse events | 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) |
| Change in total and incremental AUC insulin level (mmol/L) | 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. |
Countries
Germany
Outcome results
None listed