Effect of Sprint Interval Training and Intermittent Fasting on Cognitive Function

November 28, 2021 updated by: Western University, Canada
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will explore how a combination of a time restricted eating (TRE) strategy and a sprint interval training (SIT) exercise program will affect cognitive function. Both TRE and SIT have been shown to present significant brain challenges, and are both easily implemented lifestyle habits. Participants will be randomized into 3 groups of either SIT alone, TRE alone, or SIT + TRE. We will be assessing acute effects (single day of TRE, followed by a single session of SIT the next day), and the effects over a 6 week period. The SIT protocol consists of four 30 second sprinting bouts, separated by 2 minutes of recovery. An additional sprint bout will be added biweekly to maintain progressive overload. SIT will be performed 3 times a week for the treatment group. The TRE involves no restrictions on the type or amount of food consumed, however, food must be consumed between 12pm and 8pm. The SIT will occur in an unfed state towards the end of the fast. The study will involve sedentary young adults. To evaluate the success of the intervention, 2 cognitive tests (Stroop and Corsi block) will be performed at baseline and biweekly over a 6 week treatment period. Additionally, body composition testing will occur at baseline and once every three weeks using a BodPod. We hypothesize that the combination treatment group will have greater improvements in their cognitive function and body composition compared to either intervention alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Exercise Nutrition Laboratory (Western University)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sprint Interval Training (SIT) Protocol
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
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.
ACTIVE_COMPARATOR: Time Restricted Eating (TRE) Protocol
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
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.
ACTIVE_COMPARATOR: Combined Sprint Interval Training (SIT) and Time Restricted Eating (TRE) Protocol
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroop Performance
Time Frame: 6 Weeks
Participants' performance on the Stroop test
6 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corsi Block Performance
Time Frame: 6 Weeks
Participants' performance on the Corsi block test
6 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: 6 Weeks
Participants' body fat percentage as measured using a BodPod
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 119418

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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