NCT01515098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

January 18, 2012

Last Update Submit

March 6, 2022

Conditions

Mild Cognitive Decline

Outcome Measures

Primary Outcomes (2)

  • Change in cognitive test performance

    Measured by CANTAB

    Baseline, 180 days

  • Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)

    Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)

    Baseline, 180 days

Secondary Outcomes (2)

  • Change in body mass distribution

    Baseline, 180 days

  • Change in oxidative stress and inflammatory markers as measured in blood and urine

    Baseline, 180 days

Study Arms (3)

Blueberry Group

EXPERIMENTAL

37 grams of dehydrated blueberries daily for 6 months

Dietary Supplement: Freeze-dried blueberries

Placebo Group

PLACEBO COMPARATOR

37 grams of dextrose powder daily for 6 months

Dietary Supplement: Dextrose Placebo

Reference Group

NO INTERVENTION

No intervention

Interventions

Freeze-dried blueberriesDIETARY_SUPPLEMENT

Wild blueberries, freeze-dried and pulverized

Blueberry Group
Dextrose PlaceboDIETARY_SUPPLEMENT

Placebo developed to closely match blueberry powder.

Placebo Group

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (2)

  • 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.

    PMID: 36066009DERIVED

  • 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.

    PMID: 29523147DERIVED

Study Officials

  • Carol L Cheatham, Ph.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations

US(1)