NCT05397990

Brief Summary

The NeuroFit study will be investigating the impact of exercise on global cognition, hippocampus-dependent memory function and the gut microbiota in a middle-aged population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

January 7, 2026

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

May 20, 2022

Last Update Submit

January 5, 2026

Conditions

Cognitive Decline

Keywords

CognitionPattern separationMemory functionGut microbiotaExerciseNeurogenesisLifestyle

Outcome Measures

Primary Outcomes (2)

  • Mnemonic Similarity Task

    Pattern separation and recognition memory

    Change from baseline pattern separation and recognition memory at 12 weeks

  • Mnemonic Similarity Task

    Pattern separation and recognition memory

    Change from baseline pattern separation and recognition memory at 24 weeks

Secondary Outcomes (13)

  • Patient Health Questionnaire 9

    Change from baseline mood at 12 weeks

  • Patient Health Questionnaire 9

    Change from baseline mood at 24 weeks

  • Gut microbiome composition

    Change from baseline composition at 12 weeks

  • Metabolomic profile - Serum

    Change from baseline profile at 12 weeks

  • Metabolomic profile - Gut microbiota

    Change from baseline profile at 12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

12 weeks exercise intervention. 3 times a week, 45 minutes per session, 30 minutes of exercise.

Behavioral: Exercise

Control

NO INTERVENTION

Continue with habitual routine. Take part in weekly online socials with others in the control group.

Interventions

ExerciseBEHAVIORAL

12 weeks of moderate intensity exercise, three times a week.

Exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • BMI 20 - 30.
  • Does less than 90 minutes of moderate to vigorous physical activity per week and does not have a regular exercise routine(captured by self-reported measures)

You may not qualify if:

  • Subject is unable to understand the participant information sheet.
  • Subject is unable to provide written informed consent.
  • Subject is unable to understand and/or completely perform the cognitive testing.
  • Impaired vision that is not corrected.
  • Subject is a smoker.
  • Does not agree to maintain their habitual dietary routine.
  • Unwilling to provide blood and stool samples.
  • Is not in general good health on the basis of medical history.
  • Unable to engage in a structured exercise program as determined by the physical activity readiness questionnaire (PARQ).
  • Unwilling to engage in the prescribed exercise program 3 times a week.
  • Subject is pregnant, lactating or planning pregnancy.
  • Recent history (previous 2 years) or currently diagnosed with a significant psychiatric disorder including major depressive disorder, anxiety, bipolar disorder, schizophrenia or any other Diagnostic Statistical Manual (DSM)-IV Axis I disorder.
  • Subject has significant acute or chronic co-existing cardiovascular, respiratory, gastrointestinal illness or liver disease.
  • Subject has had major GI surgery including bariatric surgery (excluding appendectomy and cholecystectomy).
  • History of cancer in the last 5 years (excluding melanoma).
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curie Kim

London, London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sandrine Thuret, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

  • Brendon Stubbs, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 31, 2022

Study Start

March 1, 2022

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

January 7, 2026

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Anonymised study data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GB(1)