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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Pre-packaged blueberry powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
Pre-packaged placebo powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
Duke University Medical Center
Durham, North Carolina, United States
Change from baseline in pulse wave velocity at 12 weeks
Change in carotid-femoral pulse wave velocity will be assessed using applanation tonometry, (SphygmoCor Pulse Wave Velocity System)
Time frame: 0 to 12 weeks
Change from baseline in cognitive flexibility at 12 weeks
Change in cognitive performance will be assessed using a computerized task-switching test in which participants predictably alternate between two discrimination tasks.
Time frame: 0 to 12 weeks
Change from baseline in physical activity at 12 weeks
Change in physical activity will be measured using a commercial activity monitor, which will be worn 24 hr/d to capture total daily steps as the measure of physical activity.
Time frame: 0 to 12 weeks
Change from baseline in ambulatory blood Pressure at 12 weeks
Change in ambulatory blood pressure will be measured using an Ambulatory BP Monitor, with readings taken every 30 min. during the day and 60 min. at night, over a 24-hour period.
Time frame: 0 to 12 weeks
Change from baseline in total calories at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in macronutrient intake at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline in micronutrient intake at 4, 8 and 12 weeks
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline aerobic endurance at 4, 8, and 12 weeks
Change in aerobic endurance will be determined by a 6-minute walk where subjects walk as many laps as possible in 6 minutes between cones placed 100 feet apart.
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
Change from baseline hand grip strength at 4, 8 and 12 weeks
Change in maximal upper body strength will be determined using hydraulic isometric hand dynamometer.
Time frame: 0 to 12 weeks (0, 4, 8 and 12 weeks)
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