Clinical trial NCT01515098: Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline
Official title: The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Decline
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 123
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.

Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.

Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.

Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).

Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.


Eligibility criteria: Inclusion Criteria:

* Men and women age 65 and older
* BMI between 18.5 and 34.5
* Close individual to report memory decline

Exclusion Criteria:

* History of central nervous system or psychiatric disorders
* Dementia or Alzheimer's diagnosis
* Diabetes
* Smoking \>20 cigarettes/day
* Gastrointestinal/digestive disorders
* Uncontrolled chronic disease

Primary outcomes:
measure: Change in cognitive test performance
timeFrame: Baseline, 180 days
measure: Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
timeFrame: Baseline, 180 days
Secondary outcomes:
measure: Change in body mass distribution
timeFrame: Baseline, 180 days
measure: Change in oxidative stress and inflammatory markers as measured in blood and urine
timeFrame: Baseline, 180 days
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carol L Cheatham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheatham CL, Canipe LG 3rd, Millsap G, Stegall JM, Chai SC, Sheppard KW, Lila MA. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial. Nutr Neurosci. 2023 Oct;26(10):1019-1033. doi: 10.1080/1028415X.2022.2117475. Epub 2022 Sep 6.
citation: Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.