Impaired Glucose ToleranceGSE3NCT02254317
Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance
A study testing 300 mg GSE, 600 mg GSE and 900 mg GSE in people with Impaired Glucose Tolerance, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- 300 mg GSE, 600 mg GSE and 900 mg GSE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2014to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 40 to 65 years old male/female
- Body Mass Index (BMI) less than 35kg/m2
- Fasting blood sugar between 100-125 mg/dL
- Confirmed impaired glucose tolerance (IGT) upon 2 hr OGTT screening test (≥ 140 mg/dL < 200mg/dL)
- Non-smoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications or dietary supplements that would interfere with outcomes of the study.
Who cannot join
- Past smokers: abstinence for less than 2 years
- Men and women who smoke
- Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations ≥126 mg/dL
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
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- Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
- Men and women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (> 4 cups/day)
- Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-dependent Effect of Grape Seed Extract (GSE) on Glucose Control in People With Impaired Glucose Tolerance
The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT).
Read the detailed description
The proposed study is a single-center, placebo-controlled, randomized, 4-arm, crossover study that identify the lowest effective dose of GSE on glucose control in people with impaired glucose tolerance.
A planned sample size of 20 will be recruited into the study. This study will require one initial screening visit, pre-study visit, and 4 Oral Glucose Tolerance Test Days (OGTT) Days. This study will take 4-6weeks per subject to complete.
The trial will initiate with one screening visit, which will last for about 3-4 hours where the subjects' height, weight, BMI, waist circumference, fasting blood glucose, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed. OGTT procedure will be performed to confirm IGT.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first OGTT Day and for the duration of the study. A dinner meal will be provided the day before the OGTT Day to control the second meal effect from food and beverage intake of the night before the OGTT Day.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each OGTT Day will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw (baseline: -1h) in the fasting state. 3 test capsules with 0 mg GSE, 300 mg GSE, 600 mg GSE or 900 mg GSE (in forms of: 3 placebo, 2 placebo \& 1 GSE, 1 placebo \& 2 GSE or 3 GSE. Each GSE capsule containing 300 mg GSE) will be served. Thereafter, timers will be started and a glucose test drink (75g glucose mixed with 250ml water) will be given right after the 0h blood sampling (1 h after the consumption of capsules). Subject will be instructed to finish the drink in 5 minutes (min). From this point forward, blood sample will be collected at 30 min, 1h, 2hand 3h for assessment of changes in metabolic markers. The sequence of receiving the capsules treatment at each visit will be randomly assigned based on computer generated sequences.
OGTT Day visits will be placed at least 3 days apart as well.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- 0 mg placebo, 300 mg GSE, 600 mg GSE, 900 mg GSE
- Keywords
- Impaired Glucose Tolerance, Oral Glucose Tolerance Test, Grape Seed Extract
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 mg placeboDietary supplement
Also called Placebo Comparator
Not containing GSE (Placebo)
300 mg GSEDietary supplement
Also called Active Comparator1
300 mg GSE
600 mg GSEDietary supplement
Also called Active Comparator2
Containing 600 mg of GSE
900 mg GSEDietary supplement
Also called Active Comparator3
Containing 900 mg of GSE
| Study group | Role | What they receive |
|---|---|---|
| 0 mg placebo | Placebo comparator | Not containing GSE (Placebo) Receives: Dietary Supplement: 0 mg placebo |
| 300 mg GSE | Active comparator | Containing 300 mg of GSE Receives: Dietary Supplement: 300 mg GSE |
| 600 mg GSE | Active comparator | Containing 600 mg of GSE Receives: Dietary Supplement: 600 mg GSE |
| 900 mg GSE | Active comparator | Containing 900 mg of GSE Receives: Dietary Supplement: 900 mg GSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo.
plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT)
Measured: 4 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study start15 Sep 2014
- Primary completion27 Jun 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254317
- Sponsor's protocol ID
- 2014-074
- Acronym
- GSE3
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2014
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Effect of Grape Seed Extract (GSE) on Glucose Control in People With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT02254317
- Acronym / sponsor ID
- GSE3 / 2014-074
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Impaired Glucose Tolerance, Oral Glucose Tolerance Test, Grape Seed Extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 27 Jun 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT).
Detailed description
The proposed study is a single-center, placebo-controlled, randomized, 4-arm, crossover study that identify the lowest effective dose of GSE on glucose control in people with impaired glucose tolerance.
A planned sample size of 20 will be recruited into the study. This study will require one initial screening visit, pre-study visit, and 4 Oral Glucose Tolerance Test Days (OGTT) Days. This study will take 4-6weeks per subject to complete.
The trial will initiate with one screening visit, which will last for about 3-4 hours where the subjects' height, weight, BMI, waist circumference, fasting blood glucose, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed. OGTT procedure will be performed to confirm IGT.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first OGTT Day and for the duration of the study. A dinner meal will be provided the day before the OGTT Day to control the second meal effect from food and beverage intake of the night before the OGTT Day.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each OGTT Day will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw (baseline: -1h) in the fasting state. 3 test capsules with 0 mg GSE, 300 mg GSE, 600 mg GSE or 900 mg GSE (in forms of: 3 placebo, 2 placebo \& 1 GSE, 1 placebo \& 2 GSE or 3 GSE. Each GSE capsule containing 300 mg GSE) will be served. Thereafter, timers will be started and a glucose test drink (75g glucose mixed with 250ml water) will be given right after the 0h blood sampling (1 h after the consumption of capsules). Subject will be instructed to finish the drink in 5 minutes (min). From this point forward, blood sample will be collected at 30 min, 1h, 2hand 3h for assessment of changes in metabolic markers. The sequence of receiving the capsules treatment at each visit will be randomly assigned based on computer generated sequences.
OGTT Day visits will be placed at least 3 days apart as well.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mg placebo | Placebo comparator | Dietary Supplement: 0 mg placeboNot containing GSE (Placebo) |
| 300 mg GSE | Active comparator | Dietary Supplement: 300 mg GSEContaining 300 mg of GSE |
| 600 mg GSE | Active comparator | Dietary Supplement: 600 mg GSEContaining 600 mg of GSE |
| 900 mg GSE | Active comparator | Dietary Supplement: 900 mg GSEContaining 900 mg of GSE |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 40 to 65 years old male/female
- Body Mass Index (BMI) less than 35kg/m2
- Fasting blood sugar between 100-125 mg/dL
- Confirmed impaired glucose tolerance (IGT) upon 2 hr OGTT screening test (≥ 140 mg/dL < 200mg/dL)
- Non-smoker
Key exclusion criteria (13 listed)
- Past smokers: abstinence for less than 2 years
- Men and women who smoke
- Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations ≥126 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 mg placeboAlso: Placebo ComparatorNot containing GSE (Placebo) | Dietary supplement | 0 mg placebo |
| 300 mg GSEAlso: Active Comparator1300 mg GSE | Dietary supplement | 300 mg GSE |
| 600 mg GSEAlso: Active Comparator2Containing 600 mg of GSE | Dietary supplement | 600 mg GSE |
| 900 mg GSEAlso: Active Comparator3Containing 900 mg of GSE | Dietary supplement | 900 mg GSE |
Primary outcome
Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo.
Time frame: 4 hr
plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 mg GSE, 600 mg GSE and 900 mg GSE in people with Impaired Glucose Tolerance, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo. (time frame: 4 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.