Cognitive FunctionNCT05152719
Effect of Sprint Interval Training and Intermittent Fasting on Cognitive Function
A study testing Cognitive Performance in people with Cognitive Function, run by Western University, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Cognitive Performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Laboratory (Western University)
London, Ontario, N6A 3K7
About this study
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.
Read the 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.
- Conditions
- Cognitive Function
- Being tested
- Cognitive Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive PerformanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Cognitive Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Performance
Participants' performance on the Stroop test
Measured: 6 Weeks
Secondary outcomes (1)
Corsi Block Performance
Participants' performance on the Corsi block test
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start2 Dec 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152719
- Sponsor's protocol ID
- 119418
- Status last verified
- Jun 2021
- First submitted
- 3 Oct 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sprint Interval Training and Intermittent Fasting on Cognitive Function
- ClinicalTrials.gov ID
- NCT05152719
- Acronym / sponsor ID
- 119418
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 2 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sprint Interval Training (SIT) Protocol | Experimental | Behavioral: Cognitive PerformanceParticipants 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. |
| Time Restricted Eating (TRE) Protocol | Active comparator | Behavioral: Cognitive PerformanceParticipants 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. |
| Combined Sprint Interval Training (SIT) and Time Restricted Eating (TRE) Protocol | Active comparator | Behavioral: Cognitive PerformanceParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive PerformanceCognitive 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. | Behavioural | Combined Sprint Interval Training (SIT) and Time Restricted Eating (TRE) Protocol, Sprint Interval Training (SIT) Protocol, Time Restricted Eating (TRE) Protocol |
Primary outcome
Stroop Performance
Time frame: 6 Weeks
Participants' performance on the Stroop test
1 secondary outcome
Corsi Block Performance
Time frame: 6 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Performance in people with Cognitive Function, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop Performance (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.