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

InQpharm

Status and phase: Completed; Phase 3

Conditions: Prediabetes; Hyperglycemia

Treatments: Device: Placebo; Device: Dose 1 of IQP-VV-102; Device: Dose 2 of IQP-VV-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02541344

INQ/024613

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 3 patient groups, including a placebo group

Dose 1 of IQP-VV-102

Active Comparator group

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.

Treatment:

Device: Dose 1 of IQP-VV-102

Dose 2 of IQP-VV-102

Active Comparator group

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.

Treatment:

Device: Dose 2 of IQP-VV-102

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo