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

NCT ID: NCT02541344

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

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.

Conditions

Prediabetes; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dose 1 of IQP-VV-102

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.

Group Type: ACTIVE_COMPARATOR

Dose 1 of IQP-VV-102

Intervention Type: DEVICE

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

Dose 2 of IQP-VV-102

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.

Group Type: ACTIVE_COMPARATOR

Dose 2 of IQP-VV-102

Intervention Type: DEVICE

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Placebo group will take 4 placebo tablets.

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

Interventions

Dose 1 of IQP-VV-102

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

Intervention Type: DEVICE

Dose 2 of IQP-VV-102

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

Intervention Type: DEVICE

Placebo

Placebo group will take 4 placebo tablets.

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Uebelhack, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite

Locations

analyze & realize GmbH

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

INQ/024613

Identifier Type: -

Identifier Source: org_study_id