- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05152719
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
120
Phase
- 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
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Ontario
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London, Ontario, Canada, N6A 3K7
- Exercise Nutrition Laboratory (Western University)
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
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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.
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|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroop Performance
Time Frame: 6 Weeks
|
Participants' performance on the Stroop test
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6 Weeks
|
Secondary Outcome Measures
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
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
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)
December 2, 2021
Primary Completion (ANTICIPATED)
June 30, 2022
Study Completion (ANTICIPATED)
June 30, 2022
Study Registration Dates
First Submitted
October 3, 2021
First Submitted That Met QC Criteria
November 28, 2021
First Posted (ACTUAL)
December 10, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2021
Last Update Submitted That Met QC Criteria
November 28, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID 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
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