The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome).
This study will involve a 2-week "run-in" period and two 4-week "intervention" phases separated by a 3 week "washout" non-intervention phase (for a total of 13 weeks). At the start of each 4-week intervention period, subjects will be asked to participate in a "postprandial challenge" test. Subjects will be asked to first follow a 2-week run-in control period consuming habitual diets but refraining from consuming polyphenol-rich foods/beverages, including tea, berries, grapes, juices, and wine. Subjects will then be asked to consume 60 g of grape powder or placebo in random order, each for a 4-week intervention period, separated by a 3-week washout period. Subjects will be asked to prepare powder by mixing with water at breakfast (30 g) and dinner (30 g) and consume immediately after mixing (or within 30 minutes). During each 4-week intervention period, subjects will be asked to refrain from consuming polyphenol-rich foods/beverages. During the washout period subjects will not be asked to consume the powder, but should abstain from consuming polyphenol-rich foods/beverages. The grape powder is made from a composite of fresh red, green and black California grapes, based on actual consumption patterns of consumers. It is a mix of seeded and seedless varieties that have been frozen, ground with food-quality dry ice, freeze-dried, and re-ground. Subjects will also be asked to maintain normal diet and exercise habits throughout the study, with the exception being the consumption of polyphenol-rich foods/beverages. Subjects will be asked to complete a 5-day dietary record (including 1 weekend day) and a 7-day physical activity diary at the baseline and end of each intervention period. Subjects will come to the University of Connecticut Nutrition Department once every other week (biweekly) to pick up the powder (in packets), which needs to be kept frozen until consumption. For the postprandial challenge tests, subjects will be asked to fast overnight (12 hours) and then will be given a coconut oil-based lactose-free milkshake (1 g fat/kg body weight), containing 60 g of either placebo or grape powder. Subjects will be asked to spend the test day in the laboratory in a rested state and, with the exception of water, will not be permitted to consume any additional food or beverages during the 6 hours after consuming the milkshake. Subjects will be asked to abstain from alcohol and strenuous physical activity 24-hours prior to the postprandial test. To standardize short-term fat intake, subjects will be given recipes and instructed to consume a low-fat evening meal (\< 10 g fat) the night prior to postprandial tests. Subjects will also be asked to complete a 1-day food record for the day prior to the postprandial tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
60 g of whole grape powder for 4 weeks
60 g of grape powder placebo for 4 weeks
University of Connecticut
Storrs, Connecticut, United States
Fasted HDL-cholesterol
Measurement of plasma HDL-cholesterol (mg/dL) at the end of each 4-week intervention arms.
Time frame: 13 weeks
Fasted apolipoprotein B-depleted serum cholesterol efflux capacity
Measurement of fasted apolipoprotein B-depleted serum cholesterol efflux capacity (% cholesterol efflux) from macrophages loaded with tritium(3H)-labeled-cholesterol at the end of each 4-week intervention arms. Results will be expressed as percent efflux calculated as disintegrations per minute of \[3H\]-cholesterol in medium ÷ (\[3H\]-cholesterol in medium + \[3H\]-cholesterol remaining in cells) x 100.
Time frame: 13 weeks
Postprandial HDL anti-inflammatory activity
Adhesion molecule expression (micrograms/L) will be measured after incubation of human endothelial cells with HDL isolated from pre-test meal (baseline), 3 hours post-test meal, and 6 hours post-test meal time points.
Time frame: On first day of each intervention arm up to 6 hours after test meal
Postprandial HDL antioxidant activity
Paraoxonase-1 enzyme activity towards phenyl acetate (kU/L) measured in serum from pre-test meal (baseline), 3 hours post-test meal, and 6 hours post-test meal time points.
Time frame: On first day of each intervention arm up to 6 hours after test meal
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