Polyphenolic Compounds and MetabolismGSE2NCT01995643
Acute Effects of Grape Seed Extract on Insulin Sensitivity and Oxidative Stress and Inflammation Markers.
A study testing Active Capsule in people with Polyphenolic Compounds and Metabolism, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The proposed study aims to investigate that consumption of grape seed extract (GSE) would improve antioxidant status and impaired insulin action following consumption of a pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyphenolic Compounds and Metabolism
- What is being tested?
- Active Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 30 Aug 2014
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 20 to 65 years old
- Body Mass Index (BMI) range from 18.5 to 24.9 kg/m2; exception BMI 18.5 to 23 kg/m2 for Asian population
- Fasting blood glucose concentration < 110 mg/dL
- Fasting LDL-cholesterol <180 mg/dL
- Fasting Total cholesterol and Fasting Triglycerides < 250 mg/dL
- Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
Show all 11Show fewer
- Non-smokers
- 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, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
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 ≥110 mg/dL
- Men and women who have uncontrolled blood pressure >140 mmHg/90 mmHg
Show all 18Show fewer
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- 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 are taking blood pressure lowering medication that may interfere the outcomes of the study; e.g. diuretics.
- 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.
- Men and women who are vegetarians or vegans
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (> 4 cups/day)
- Men and women who do excessive exercise regularly or athlete
- 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
- Women who are lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Effect of Grape Seed Extract on Modulation of Oxidative Stress/ Inflammation/ Insulin Sensitivity Induced by High Fat-carbohydrate Meal in Healthy Human Subjects
The proposed study aims to investigate that consumption of grape seed extract (GSE) would improve antioxidant status and impaired insulin action following consumption of a pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.
Read the detailed description
This study is a single-center, double blind, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study
A planned sample size of 15 will be recruited into the study. This study will require one initial screening, one pre-study visit, two 6-hour study visits. The study will take 2-5 weeks per subject to complete.
The initial screening visit will provide subjects an Institutional Review Board approved consent document and determine subject eligibility through BMI calculated from height and weight measurements, vital signs, fasting blood glucose test (finger prick), lipid profiles (3 ml blood sampling via a butterfly needle device) and completion of a questionnaire related to general eating, health, and exercise habits.
If subjects are willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at the initial screening visit and collected at the pre-study visit to assess subjects' usual dietary intake pattern. After reviewing food records, subjects will be instructed to avoid any grapes, grape products, berries, berry products throughout the study and strictly follow a limited polyphenolic diet for 3 days prior to each 6-hr study visit, while maintaining their usual diet pattern and physical activity. Prior to each study visit, subject will be advised to have the same or similar dinner meal to control the second meal effect from food and beverage intake of the night before each study visit.
Subjects will arrive at the center after ~10 hours overnight fasting, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and fasting blood glucose test), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and collect fasting blood sample. During each study visit, subject will take one of the two capsules right after fasting blood draw), based on randomization sequences (either 1 grape seed extract capsule or 1 placebo capsule). One hour after administration of the assigned capsule, blood samples will be collected. And a standard high carbohydrate and high fat breakfast meal will be served and subject will have blood draws at designated time up to 5 hours.
- Conditions
- Polyphenolic Compounds and Metabolism
- Being tested
- Active Capsule, Placebo Capsule
- Keywords
- Grape seed extract, Polyphenols, Insulin, Oxidative stress Marker, Inflammatory marker, Healthy human
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CapsuleDietary supplement
GSE Capsule
Placebo CapsuleDietary supplement
Placebo Capsule
| Study group | Role | What they receive |
|---|---|---|
| Active Capsule | Active comparator | Grape Seed Extract Capsule: 300 mg Receives: Dietary Supplement: Active Capsule |
| Placebo Capsule | Placebo comparator | Placebo Capsule: Maltodextrin Receives: Dietary Supplement: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin and glucose concentrations over 6 hours after the Grape Seed Extract Capsule administration
The timing influence of the Grape Seed Extract administration on insulin and glucose concentrations in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)
Measured: 6 hours
Secondary outcomes (1)
Changes in oxidative stress markers and inflammatory markers over 6 hours after the Grape Seed Extract Capsule administration
The timing influence of grape seed extract administration on oxidative stress markers and inflammatory markers in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start1 Oct 2013
- Primary completion1 Aug 2014
- Study completion30 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyphenolic Compounds and MetabolismStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Indika Edirisinghe, Ph.D, Principal investigator, Institute for Food Safety and HealthBritt Burton-Freeman, Ph.D, MS, Study chair, Institute for Food Safety and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995643
- Sponsor's protocol ID
- 2013-114
- Acronym
- GSE2
- Status last verified
- Jul 2020
- First submitted
- 21 Nov 2013
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Grape Seed Extract on Modulation of Oxidative Stress/ Inflammation/ Insulin Sensitivity Induced by High Fat-carbohydrate Meal in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01995643
- Acronym / sponsor ID
- GSE2 / 2013-114
- Conditions
- Polyphenolic Compounds and Metabolism
- Keywords
- Grape seed extract, Polyphenols, Insulin, Oxidative stress Marker, Inflammatory marker, Healthy human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 30 Aug 2014 (actual)
- First posted
- 26 Nov 2013 (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 proposed study aims to investigate that consumption of grape seed extract (GSE) would improve antioxidant status and impaired insulin action following consumption of a pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.
Detailed description
This study is a single-center, double blind, placebo-controlled, randomized, 2-arm, 2-sequence, crossover study
A planned sample size of 15 will be recruited into the study. This study will require one initial screening, one pre-study visit, two 6-hour study visits. The study will take 2-5 weeks per subject to complete.
The initial screening visit will provide subjects an Institutional Review Board approved consent document and determine subject eligibility through BMI calculated from height and weight measurements, vital signs, fasting blood glucose test (finger prick), lipid profiles (3 ml blood sampling via a butterfly needle device) and completion of a questionnaire related to general eating, health, and exercise habits.
If subjects are willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at the initial screening visit and collected at the pre-study visit to assess subjects' usual dietary intake pattern. After reviewing food records, subjects will be instructed to avoid any grapes, grape products, berries, berry products throughout the study and strictly follow a limited polyphenolic diet for 3 days prior to each 6-hr study visit, while maintaining their usual diet pattern and physical activity. Prior to each study visit, subject will be advised to have the same or similar dinner meal to control the second meal effect from food and beverage intake of the night before each study visit.
Subjects will arrive at the center after ~10 hours overnight fasting, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and fasting blood glucose test), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and collect fasting blood sample. During each study visit, subject will take one of the two capsules right after fasting blood draw), based on randomization sequences (either 1 grape seed extract capsule or 1 placebo capsule). One hour after administration of the assigned capsule, blood samples will be collected. And a standard high carbohydrate and high fat breakfast meal will be served and subject will have blood draws at designated time up to 5 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Capsule | Active comparator | Dietary Supplement: Active CapsuleGrape Seed Extract Capsule: 300 mg |
| Placebo Capsule | Placebo comparator | Dietary Supplement: Placebo CapsulePlacebo Capsule: Maltodextrin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged between 20 to 65 years old
- Body Mass Index (BMI) range from 18.5 to 24.9 kg/m2; exception BMI 18.5 to 23 kg/m2 for Asian population
- Fasting blood glucose concentration < 110 mg/dL
- Fasting LDL-cholesterol <180 mg/dL
- Fasting Total cholesterol and Fasting Triglycerides < 250 mg/dL
Key exclusion criteria (18 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 ≥110 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 |
|---|---|---|
| Active CapsuleGSE Capsule | Dietary supplement | Active Capsule |
| Placebo CapsulePlacebo Capsule | Dietary supplement | Placebo Capsule |
Primary outcome
Changes in insulin and glucose concentrations over 6 hours after the Grape Seed Extract Capsule administration
Time frame: 6 hours
The timing influence of the Grape Seed Extract administration on insulin and glucose concentrations in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)
1 secondary outcome
Changes in oxidative stress markers and inflammatory markers over 6 hours after the Grape Seed Extract Capsule administration
Time frame: 6 hours
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 27 Jul 2021.
Related trials for Polyphenolic Compounds and Metabolism
Recruiting
Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements
Healthy Adult Participants, ADME
Enrolling by invitation
Bioavailability From Chickpea Meals in Ileostomists?
Nutrition, Absorption
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.
Indika Edirisinghe, Ph.D principal investigator
Institute for Food Safety and Health
Britt Burton-Freeman, Ph.D, MS study chair
Institute for Food Safety and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Capsule in people with Polyphenolic Compounds and Metabolism, 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 11 inclusion and 18 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 27 Jul 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 insulin and glucose concentrations over 6 hours after the Grape Seed Extract Capsule administration (time frame: 6 hours). 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 27 Jul 2021.