NCT04654936

Brief Summary

This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

November 5, 2020

Last Update Submit

December 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Tests used for this study were spatial working memory (SWM), spatial span (SSP), pattern recognition memory (PRM) and reaction time (RTI). These tests are computerised and measure the length of time it takes to complete task in milliseconds.

    12 weeks

Secondary Outcomes (3)

  • Mood

    12 weeks

  • World Health Organisation Bref Quality of life

    12 weeks

  • Capability, opportunity, motivation and behaviour model

    12 weeks

Study Arms (3)

MIND diet with support

EXPERIMENTAL

This intervention group are to follow the MIND diet guidelines for 12 weeks with the support of a 12 week online theory driven website and resources

Behavioral: MIND diet

MIND diet no support

EXPERIMENTAL

This group are to follow the MIND diet guidelines with no website support

Behavioral: MIND diet with no support

Control

NO INTERVENTION

The group follow usual diet

Interventions

MIND dietBEHAVIORAL

12 week MIND diet study: Participants access a website that is theory driven using the Behaviour Change Wheel to help motivate and promote MIND diet adherence. Participants are to consume MIND diet foods daily and meet MIND diet weekly recommendations

MIND diet with support

Participants are to consume MIND diet food recommendations over a 12 week period with no support except for a self-monitoring resource and MIND diet guidelines

MIND diet no support

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female aged 40-55 living in NI

You may not qualify if:

  • Anyone on a specific dietary pattern (veganism, vegetarian, Atkins)
  • Anyone on a specific diet recommended by their Doctor (eating disorder)
  • Specific illnesses such as high cholesterol, diabetes, heart disease, dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life and Health Science

Londonderry, United Kingdom

Location

Related Publications (1)

  • Timlin D, McCormack JM, Kerr M, Keaver L, Simpson EEA. The MIND diet, cognitive function, and well-being among healthy adults at midlife: a randomised feasibility trial. BMC Nutr. 2025 Mar 25;11(1):59. doi: 10.1186/s40795-025-01020-6.

Study Officials

  • Liz Simpson, PhD

    Ulster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: This study includes 2 intervention arms and one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 5, 2020

First Posted

December 4, 2020

Study Start

May 16, 2019

Primary Completion

November 6, 2019

Study Completion

November 6, 2019

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations