NCT03365544

Brief Summary

This study will examine the effect of eating timing on body composition. Previous studies have shown that restricting food intake to 8 hours a day can result in losses in body fat and an up-regulation of fat use. The purpose of this study is to assess changes in body composition when the eating window time is from 6am-2pm vs 2pm-10pm. Hypothesis: The 2-10pm eating window will result in significantly greater changes in body composition (i.e. decreased fat mass) and the 2pm-10pm window will result in better adherence. Methods: Body composition (fat and lean mass) will be assessed by air displacement densitometry (Bod Pod). Measures will be made over 4 weeks (pre-) and (post) dietary treatment. Adherence will also be assessed by a questionnaire to determine the ease/difficulty of the treatment.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1 month

First QC Date

November 27, 2017

Last Update Submit

December 1, 2017

Conditions

Time-Restricted Eating (16:8)Fasting

Outcome Measures

Primary Outcomes (1)

  • Change in Fat mass using "Bod Pod"

    Measuring the change in fat mass between the two groups using air displacement densitometry "Bod Pod"

    4 weeks

Secondary Outcomes (1)

  • Adherence using the dialysis diet and fluid non-adherence questionnaire.

    4 weeks

Study Arms (2)

6am-2pm eating window

EXPERIMENTAL

4 weeks of time restricted eating between 6am-2pm.

Other: Time-restricted eating

2pm-10pm eating window

EXPERIMENTAL

4 weeks of time restricted eating between 2pm-10pm.

Other: Time-restricted eating

Interventions

Time-restricted eatingOTHER

Groups will be required to only ingest calories in their designated 8 hour eating window.

Also known as: Intermittent Fasting
2pm-10pm eating window6am-2pm eating window

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • men and women

You may not qualify if:

  • Body mass index less than 26
  • No history of intermittent fasting in the past 6 months
  • No participants with diabetes
  • Are pregnant or become pregnant (self-reported)
  • Have symptoms or take medication for a respiratory, cardiovascular, neuromuscular, or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

Location

Related Publications (3)

  • Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.

    PMID: 27737674BACKGROUND

  • Rothschild J, Hoddy KK, Jambazian P, Varady KA. Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. Nutr Rev. 2014 May;72(5):308-18. doi: 10.1111/nure.12104. Epub 2014 Apr 16.

    PMID: 24739093BACKGROUND

  • Tinsley GM, La Bounty PM. Effects of intermittent fasting on body composition and clinical health markers in humans. Nutr Rev. 2015 Oct;73(10):661-74. doi: 10.1093/nutrit/nuv041. Epub 2015 Sep 15.

    PMID: 26374764BACKGROUND

MeSH Terms

Conditions

Intermittent FastingFasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Peter Lemon, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD

CONTACT

519-661-2111plemon@uwo.ca

Bryce Knapp

CONTACT

807-620-0441bknapp3@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group has their eating window between 6am-2pm and the other has their eating window between 2pm-10pm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of School of Kinesiology

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)