Effects of Blueberry Consumption on Vascular Function, Physical Activity, and Cognition in Sedentary Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change from baseline in pulse wave velocity at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 and older
- •Overweight (BMI ≥25 to 35 kg/m2)
- •Well-controlled blood pressure (< 150/90 mmHg)
- •Able to speak and understand spoken and written English
- •Cognitively normal (Mini-Cog score 3-5)
- •Able to walk independently
- •Social security number (required for compensation)
- •Own a smartphone or other mobile device capable of downloading the Garmin Connect app
排除标准
- •Exercise > 150 minutes/week
- •Unwillingness or inability to be randomized to any one of two intervention groups without knowing which (double-blind), submit to all study testing, or continuously participate in a randomly assigned diet and exercise intervention for six months.
- •Unwilling to restrict consumption of anthocyanin-rich foods
- •Unwillingness to abstain from mood altering drugs (including marijuana but excluding CBDs) for 7 days prior to baseline and endpoint testing.
- •Self-reported vegetarian or vegan.
- •Inability to complete written recording forms including journals of eating and exercise behaviors.
- •Inability to complete written and computerized cognitive tasks (presented in English).
- •Allergy or intolerance to blueberry or placebo powder ingredients Placebo ingredients include: maltodextrin, fructose, artificial blueberry flavor, natural blueberry flavor, artificial purple color (water, FD&C Red #40, FD&C Blue #1, malic acid, sodium benzoate) citric acid, and artificial red color (water, FD&C Red #40, malic acid, sodium benzoate, silica dioxide).
- •Gastrointestinal disorders that influence digestion and absorption of food, e.g., IBD
- •History of frequent urinary tract or Clostridium difficile infections
- •Presence of unstable, acutely symptomatic, or life-limiting illness.
- •Regular use of medication that interferes with the measurement of study outcomes as determined by the study physician.
- •Unstable use of medications, other than statins, for conditions associated with metabolic syndrome (hypertension, diabetes, dyslipidemia) during the prior 6 months or during the study.
- •Antibiotic use in the last 3 months.
- •Cigarette smoking, chewing, or use of nicotine replacement products in the past 3 months or during the course of the study.
- •Colonoscopy in last 2 months.
- •History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure effecting absorption.
- •History of significant weight instability (defined as > 10 pounds weight gain or loss over one month prior to study participation).
- •History of cancer treatment (other than melanoma skin cancer) and not "cancer-free" for at least 1 year.
- •History of anti-hormonal therapy (eg., for breast or prostate cancer) within the last 6 months.
结局指标
主要结局
Change from baseline in pulse wave velocity at 12 weeks
时间窗: 0 to 12 weeks
Change in carotid-femoral pulse wave velocity will be assessed using applanation tonometry, (SphygmoCor Pulse Wave Velocity System)
次要结局
- Change from baseline in ambulatory blood Pressure at 12 weeks(0 to 12 weeks)
- Change from baseline in macronutrient intake at 4, 8 and 12 weeks(0 to 12 weeks (0, 4, 8 and 12 weeks))
- Change from baseline in total calories at 4, 8 and 12 weeks(0 to 12 weeks (0, 4, 8 and 12 weeks))
- Change from baseline in micronutrient intake at 4, 8 and 12 weeks(0 to 12 weeks (0, 4, 8 and 12 weeks))
- Change from baseline in physical activity at 12 weeks(0 to 12 weeks)
- Change from baseline aerobic endurance at 4, 8, and 12 weeks(0 to 12 weeks (0, 4, 8 and 12 weeks))
- Change from baseline in cognitive flexibility at 12 weeks(0 to 12 weeks)
- Change from baseline hand grip strength at 4, 8 and 12 weeks(0 to 12 weeks (0, 4, 8 and 12 weeks))