- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704699
Effect of Early Eating and Stair Climbing on Body Composition
January 19, 2023 updated by: Peter Lemon, Western University, Canada
Effect of Early Time Restricted Eating and Brief Intense Stair Climbing on Body Composition
To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks.
There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days.
The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here.
The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults.
The eating window also began later in the morning at 1000h and finished at 1800h.
There also was no restriction on participants consuming caffeine during the fasting window.
The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition.
The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8.
The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window.
Furthermore, none of the studies mentioned above examined eTRE against eTRE with Brief Intense Stair Climbing (BISC) directly.
We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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 Contact
- Name: Reed Zehr, MSc
- Phone Number: 519-661-2111
- Email: rzehr2@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A3K7
- 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
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- sedentary- lightly physically active (<7,500 steps daily)
- BMI > 25 • 18-39 years old
Exclusion Criteria:
Have diabetes (self-reported)
- Have history of smoking (self-reported)
- Have history of cardiovascular disease (self-reported)
- Have BMI of <24.9
- Are pregnant or become pregnant during the study (self-reported)
- Take medication for weight loss (self-reported)
- Physical activity level > 7500 steps/day
- Unstable weight for 3 months prior to commencement of study (>4kg weight loss/gain) • Employed in a shift work position
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eTRE
participants allocated to this group are required to consume food during 0800h and 1600h.
|
eating between 0800h and 1600h daily
|
Active Comparator: eTRE with BISC
participants allocated to this group are required to consume food during 0800h and 1600h as well as complete 3 sessions of BISC per week.
|
eating between 0800h and 1600h daily and completing 3 sessions of BISC per week of study duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: less than 5 mins
|
fat mass vs. fat-free mass via BodPod
|
less than 5 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
upper body strength test
Time Frame: < 15 mins
|
3-rep max bench press
|
< 15 mins
|
lower body strength test
Time Frame: < 15 mins
|
3-rep max leg press
|
< 15 mins
|
health related quality of life questionnaire
Time Frame: < 10 mins
|
subjective feelings of well-being per participant
|
< 10 mins
|
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)
March 1, 2023
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Estimate)
January 30, 2023
Study Record Updates
Last Update Posted (Estimate)
January 30, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 122046
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.
Clinical Trials on eTRE (Early Time Restricted Eating)
-
Western University, CanadaNot yet recruitingeTRE (Early Time Restricted Eating) With BCAA | eTRE (Early Time Restricted Eating)Canada
-
Western University, CanadaUnknowneTRE (Early Time Restricted Eating) | lTRE (Late Time Restricted Eating)Canada
-
University of Mississippi, OxfordRecruitingTime Restricted EatingUnited States
-
University of OklahomaCompletedTime Restricted EatingUnited States
-
Western University, CanadaUnknown
-
University of DelawareRecruitingDiet, Healthy | Eating Behavior | Nutrition, Healthy | Time Restricted EatingUnited States
-
University of California, San DiegoSalk Institute for Biological StudiesCompleted
-
Federal University of Rio Grande do SulNot yet recruitingEffects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and ObesityObesity | Overweight and Obesity | Time Restricted Feeding | Intermittent Fasting | Time Restricted Eating
-
Medical University of GdanskActive, not recruitingWellbeing | Mental Health Wellness 1 | Biochemical Markers | Physical Exercise | Time Restricted EatingPoland
-
Children's Hospital Los AngelesRecruitingPediatric Obesity | Time Restricted Feeding | Time Restricted EatingUnited States
Clinical Trials on eTRE
-
First Affiliated Hospital Xi'an Jiaotong UniversityNot yet recruitingMetabolic Syndrome | Overweight and Obesity | Time Restricted Eating
-
Institut Investigacio Sanitaria Pere VirgiliNot yet recruiting
-
University College DublinSt. James's Hospital, IrelandRecruitingInflammation | Obesity | Liver Fat | Non-Alcoholic Fatty Liver DiseaseIreland