NCT05152719

Brief Summary

Several lifestyle modifications, such as manipulating diet and exercise, have been shown to enhance cognitive function. This study aims to determine if a combination of Sprint Interval Training (SIT) and Time Restricted Eating (TRE) elicits greater enhancements in cognitive function than either of these interventions alone. SIT and TRE have both been proven to have high adherence rates and require minimal lifestyle changes, therefore the implementation of these may allow for a feasible method of improving cognition in healthy populations. A group of young adults will be randomized into either a SIT group, TRE group, or a SIT+TRE group. To assess the changes in cognitive function, cognitive tests will be performed at baseline and biweekly. Secondly, we will be monitoring the differences in the three groups in terms of body composition, which will be measured using a BodPod. It is hypothesized that the SIT+TRE group will display the greatest improvements in cognitive function and body composition versus the TRE only group and the SIT only group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 10, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

October 3, 2021

Last Update Submit

November 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stroop Performance

    Participants' performance on the Stroop test

    6 Weeks

Secondary Outcomes (1)

  • Corsi Block Performance

    6 Weeks

Other Outcomes (1)

  • Body Composition

    6 Weeks

Study Arms (3)

Sprint Interval Training (SIT) Protocol

EXPERIMENTAL

Participants in the SIT group will start with a 5 minute warm-up jogging at around 70-80% of their heart rate max. The SIT protocol consists of 30 second intervals of "all out" shuttle runs, seperated by 2 minutes of low pace walking active rest. This will be repeated between 4 times during the first 2 weeks, 5 times during the second 2 weeks, and 6 times during the third 2 weeks. Participants will be instructed to sprint the greatest possible distance in 30 seconds, starting by running to the 5m marker and back, then to the 10m marker and back, then to the 15m marker etc. The SIT session will finish with 2 minutes walking at a pace 50% of their heart rate max.

Behavioral: Cognitive Performance

Time Restricted Eating (TRE) Protocol

ACTIVE COMPARATOR

Participants will be asked to limit their food intake to the hours between 12pm to 8pm, and fast outside of these hours. During the fast, participants may consume zero calorie beverages with no caffeine or artificial sweetener. Participants are instructed to maintain their diet, with no restrictions on the type or amount of food consumed in the feeding window.

Behavioral: Cognitive Performance

Combined Sprint Interval Training (SIT) and Time Restricted Eating (TRE) Protocol

ACTIVE COMPARATOR

Participants will be asked to abide by the same eating regimen as the Time Restricted Eating Protocol Arm. Additionally, participants in this arm will perform the SIT protocol, in the fasted state. The SIT protocol will be identical to that listed in the Sprint Interval Training Protocol Arm.

Behavioral: Cognitive Performance

Interventions

Cognitive function will be measured biweekly 20 minutes after exercise, or at a matched time for the Time Restricted Eating Protocol arm. The Stroop test will be completed on Mondays and the Corsi block test will be completed on Wednesdays. Body composition will be measured on Fridays using a BodPod at baseline, week 3, and week 6.

Combined Sprint Interval Training (SIT) and Time Restricted Eating (TRE) ProtocolSprint Interval Training (SIT) ProtocolTime Restricted Eating (TRE) Protocol

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-39 years old
  • Sedentary (not meeting 50 minutes of moderate to vigorous physical activity per week)
  • Pass the Physical Activity Readiness (PARQ) questionnaire

You may not qualify if:

  • Have diabetes (self-reported)
  • Have a history of smoking (self-reported)
  • Take medication for weight loss (self-reported)
  • Are pregnant, become pregnant, or are breastfeeding during the study (self-reported)
  • Physical activity \>50 minutes of moderate to vigorous physical activity per week
  • Unstable weight during the 6 months prior to commencement of study (\>4kg weight loss/gain)
  • Have uncontrolled hypertension blood pressure \>160/90
  • Have a history of heart disease, previous myocardial infarction, or stroke
  • Have participated in a sprint interval training exercise program in the past 6 months
  • Have participated in regular intermittent fasting (≥2 weeks) in the past 6 months
  • Have BMI under 18.5 or over 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study will include participants aged 18-39, 3 conditions analyzed for cognitive function and body composition. It will involve 120 participants randomly assigned to one of three groups with either sprint interval training, time restricted eating, or both. The study will be 6 weeks in duration.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

December 10, 2021

Study Start

December 2, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 10, 2021

Record last verified: 2021-06

Locations