Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedNovember 10, 2015
November 1, 2015
1.3 years
August 24, 2015
November 9, 2015
Conditions
Outcome Measures
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.
Measures raised PPG AUC levels (mmol/L) from 0-120 minutes on each visit
120 minutes
Secondary Outcomes (10)
Change in incremental PPG AUC level (mmol/L)
120 minutes
Change in total and incremental PPG AUC level (mmol/L)
180 minutes
Changes in PPG concentration
180 minutes
Dose response of PPG level
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)
180 minutes
- +5 more secondary outcomes
Study Arms (3)
Dose 1 of IQP-VV-102
ACTIVE COMPARATORTotal 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.
Dose 2 of IQP-VV-102
ACTIVE COMPARATORTotal 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.
Placebo
PLACEBO COMPARATORTotal 4 placebo tablets, 15 minutes before test meals (on 3 treatment days at the study site) with 200mL of water.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
analyze & realize GmbH
Berlin, State of Berlin, 10369, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf Uebelhack, PhD
Charite
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
September 4, 2015
Study Start
June 1, 2014
Primary Completion
October 1, 2015
Last Updated
November 10, 2015
Record last verified: 2015-11