Status:
COMPLETED
Blueberry Enhances Activity and Cognition Through Increased Vascular Efficiency
Lead Sponsor:
Duke University
Collaborating Sponsors:
U.S. Highbush Blueberry Council
Conditions:
Sedentary Lifestyle
Blood Pressure
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 powd...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04049162
Start Date
September 20 2019
End Date
November 22 2022
Last Update
January 20 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710