NCT05704699

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

January 19, 2023

Last Update Submit

January 19, 2023

Conditions

eTRE (Early Time Restricted Eating)eTRE With BISC (Brief Intense Stair Climbing)

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    fat mass vs. fat-free mass via BodPod

    less than 5 mins

Secondary Outcomes (3)

  • upper body strength test

    < 15 mins

  • lower body strength test

    < 15 mins

  • health related quality of life questionnaire

    < 10 mins

Study Arms (2)

eTRE

EXPERIMENTAL

participants allocated to this group are required to consume food during 0800h and 1600h.

Behavioral: eTRE

eTRE with BISC

ACTIVE COMPARATOR

participants allocated to this group are required to consume food during 0800h and 1600h as well as complete 3 sessions of BISC per week.

Behavioral: eTRE with BISC

Interventions

eTREBEHAVIORAL

eating between 0800h and 1600h daily

eTRE
eTRE with BISCBEHAVIORAL

eating between 0800h and 1600h daily and completing 3 sessions of BISC per week of study duration

eTRE with BISC

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary- lightly physically active (\<7,500 steps daily)
  • BMI \> 25 • 18-39 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory, Western University

London, Ontario, N6A3K7, Canada

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Central Study Contacts

Peter Lemon, PhD

CONTACT

519-661-2111plemon@uwo.ca

Reed Zehr, MSc

CONTACT

519-661-2111rzehr2@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Peter Lemon

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations

CA(1)