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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05152719
Other study ID # 119418
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2, 2021
Est. completion date June 30, 2022

Study information

Verified date June 2021
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Exercise Nutrition Laboratory (Western University) London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Body Composition Participants' body fat percentage as measured using a BodPod 6 Weeks
Primary Stroop Performance Participants' performance on the Stroop test 6 Weeks
Secondary Corsi Block Performance Participants' performance on the Corsi block test 6 Weeks
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