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Effects of Blueberry Consumption on Vascular Function, Physical Activity, and Cognition in Sedentary Older Adults
Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as physical activity and cognitive function, in sedentary older adults (\>60 years). We will compare these effects to the same outcomes with a control group consuming a blueberry placebo (P-EX) at 0, 4, 8 and 12 weeks.
A 12-week randomized, double-blind, placebo-controlled physical activity intervention will be administered in sedentary older (\>60 years) women and men randomized to either lyophilized blueberry powder, rehydrated and consumed as a beverage twice daily with meals (BB-EX; n = 25), or an indistinguishable placebo powder, taken in the same manner (placebo control; P-EX; n = 25). Vascular function (primary outcome), 24-hr ambulatory blood pressure, cognitive performance, and related secondary measures will be assessed at 0 and 12 weeks; berry and nutrient intake and function are assessed every 4 weeks; and physical activity as step counts will be continuously monitored using a mobile device (Garmin). Blood, urine (24-hr), and stool samples will be collected at 0 and 12 weeks and archived for later analysis. The 12-week study duration is based upon the timing of vascular responses seen in other trials, as well as the minimal time needed to expect a change in cognitive performance in an older adult population. The blueberry dose of 36 grams per day in a split dose consumed with meals is based on (1) a 33% increase in dose over that previously used in a longer (6-month) trial; (2) delivering the most effective dose of blueberry bioactives; and (3) reduced likelihood of any gastrointestinal symptoms.
Age
60 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Duke University Medical Center
Durham, North Carolina, United States
Start Date
September 20, 2019
Primary Completion Date
November 22, 2022
Completion Date
November 22, 2022
Last Updated
January 20, 2023
84
ACTUAL participants
Blueberry Plus Exercise (BB-EX)
DIETARY_SUPPLEMENT
Blueberry Placebo Plus Exercise (P-EX)
DIETARY_SUPPLEMENT
Lead Sponsor
Duke University
Collaborators
NCT07482930
NCT07324902
Data Source & Attribution
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