NCT01515098: BERRY

The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline

Completed NA Last updated 6 March 2022

What this trial tests

NA trial testing Freeze-dried blueberries in Mild Cognitive Decline in 123 participants. Completed in 1 March 2015.

Timeline

1 January 2012

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	123
Start date	1 January 2012
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	1 location across United States

Drugs / interventions tested

• Freeze-dried blueberries
• Dextrose Placebo

Conditions studied

• Mild Cognitive Decline — all drugs for Mild Cognitive Decline →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 65 to 79, any sex, with Mild Cognitive Decline. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in cognitive test performance
  Time frame: Baseline, 180 days
  Measured by CANTAB
• Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
  Time frame: Baseline, 180 days
  Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Sheppard KW, Cheatham CL. · · 2018 · cited 52× · PMID 29523147 · DOI 10.1186/s12944-018-0693-9
2. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial.
   Cheatham CL, Canipe LG, Millsap G, Stegall JM, et al · · 2023 · cited 19× · PMID 36066009 · DOI 10.1080/1028415x.2022.2117475