Chardonnay Grape Pomace Study |
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Health Effects of Chardonnay Grape Pomace Powder
Who is conducting the study?
Nancy L. Keim, PhD, from the Western Human Nutrition Research Center (WHNRC) and Department of Nutrition, at the University of California, Davis.
Where is the study being conducted?
WHNRC, 430 West Health Sciences Drive, University of California, Davis, California, 95616 Directions
What is the purpose of this study?
We hope to learn if the addition of grape pomace powder to your daily diet will result in certain health benefits such as reducing blood levels of cholesterol or triglycerides. The grape pomace powder will be provided in capsule form so that the amount provided can be controlled.
Who can participate in this study?
Overweight adult men and women between the ages of 35 and 65 years who have blood lipid levels at the upper end of normal or mildly elevated.
What would exclude me from participating in the study?
- BMI <25 and >39.9kg/m2
- Chronic diseases such as type 2 diabetes, cardiovascular disease
- High blood pressure
- Gastrointestinal disorders
- Pregnant or planning a pregnancy
- Current use of tobacco products
What can I expect to happen during the study?
If qualified, and you decide to participate, you will be enrolled in the study for a period of 16 weeks. There are three different treatments of the grape seed flour each one lasting for 3 weeks: none (the placebo), a low amount, and a higher amount. Each volunteer will go through all three treatments, in a random order. The study design includes two breaks in the study schedule after the first treatment (week 4) and again after the second treatment (week 10), so you are actively engaged in the study for a total of 10 weeks. Below is a brief description of what happens during the study.
Volunteers will be screened for eligibility first with a 20-minute telephone interview and then with a separate 2-hour visit to the WHNRC. The screening visit requires that you fast overnight with nothing to eat or drink (except water) for about 12 hours before your appointment. At this appointment we will:
- Go through the consent process by reviewing, discussing, and signing the consent
- Height and weight measurements
- Waist circumference measurements
- Blood pressure and pulse measurements
- Blood sample obtained
- Complete health history and physical activity questionnaires
Results of the data collected will determine eligibility into the main study. Only qualified volunteers will be asked to participate in the remaining study visits.
During the first week of the study:
- Orientation (3-hour visit)
Volunteers will come to the WHNRC for a 3-h visit to review study schedule, take vitals and body composition measurements, and receive training for at home data collections including the 24-hour dietary recalls and fecal collections. Volunteers will also go through an orientation to procedures that will be done on the study test days.
- Collection of fecal sample (at home)
This sample will provide baseline values.
During study weeks 2-4, 8-10, and 14-16:
- Weekly visits (15-20 minutes)
Volunteers will come to WHNRC each week to pick up the grape seed flour capsules, turn in capsule logs, and fill out GI symptoms questionnaire.
- 24-hour dietary recalls
Volunteers will complete 21 separate recalls that are scheduled randomly during these weeks. On average, you can expect to do these 2 or 3 times per week.
During study weeks 4, 10, and 16:
- Test days (6-hour visit)
Volunteers will come to WHNRC for testing that includes measurements of vital signs, weight and body composition, assessment of blood vessel function, collection of blood and breath samples before and after eating a standard test meal, rating your appetite, and a series of mental tasks.
- Collection of fecal sample (at home)
These samples will provide values representing the three different treatments of grape pomace powder.
What is your compensation from this study?
If the study is completed the total compensation is $600. Volunteers will be compensated only for the portions of the study completed.
What should I do if I have questions or want to participate in the study?
For questions, contact the study coordinator, Fanny Lee, at 530-754-7781 or fanlee@ucdavis.edu.
To begin the screening process, please call 530-752-5177 #2.