Acute Effects of Grape Seed Extract on Insulin Sensitivity and Oxidative Stress and Inflammation Markers. (GSE2)
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|ClinicalTrials.gov Identifier: NCT01995643|
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Polyphenolic Compounds and Metabolism||Dietary Supplement: Active Capsule Dietary Supplement: Placebo Capsule||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 1, 2013|
|Actual Primary Completion Date :||August 1, 2014|
|Actual Study Completion Date :||August 30, 2014|
Active Comparator: Active Capsule
Grape Seed Extract Capsule: 300 mg
Dietary Supplement: Active Capsule
Placebo Comparator: Placebo Capsule
Placebo Capsule: Maltodextrin
Dietary Supplement: Placebo Capsule
- 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)
- Changes in oxidative stress markers and inflammatory markers over 6 hours after the Grape Seed Extract Capsule administration [ Time Frame: 6 hours ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995643
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Indika Edirisinghe, Ph.D||Institute for Food Safety and Health|
|Study Chair:||Britt Burton-Freeman, Ph.D, MS||Institute for Food Safety and Health|