Acute Time-Restricted Eating in Young Healthy Males

March 24, 2022 updated by: William Mode, Nottingham Trent University

The Effect of Acute Time-Restricted Eating on Energy Intake, Subjective Appetite and Glycaemic Control in Young Healthy Males

This study compared the metabolic response to three different eating windows (morning fast,12pm-8pm; evening fast, 8am-4pm; control, 8am-8pm).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post-intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake, and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

Study Type

Interventional

Enrollment (Actual)

18

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 Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG2 5BL
        • Nottingham Trent 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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • recreationally active
  • non-smokers
  • non-dieting
  • weight stable (self-reported for >6 months)
  • were not consuming any medication known to affect appetite or physical activity

Exclusion Criteria:

  • Smokers
  • >10 hours per week physical activity
  • Have dieted within the past 6 months
  • Excessive alcohol consumption (>14 units/week)
  • Use of medication or supplements that may affect hormone concentrations.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evening Fasting
Participants will undertake acute evening fasting (feeding between 8am-4pm)
Behavioral: Evening Fasting
Participants will undertake acute evening fasting (feeding between 8am-4pm) for one day. After which they will attend the laboratory, following a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.
Experimental: Control
Participants will undertake an acute standard western feeding pattern (feeding between 8am-8pm).
Behavioral: Control
Participants will undertake an acute standard western feeding pattern (feeding between 8am-8pm). After which, participants will visit the laboratory the following day, after a 12 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.
Experimental: Morning Fasting
Participants will undertake an acute morning fasting trial (feeding between 12pm-8pm).
Behavioral: Morning Fasting
Participants will undertake an acute morning fasting trial (feeding between 12pm-8pm). After which, participants will visit the laboratory the following day, after a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic Control
Time Frame: 0 hour (Pre breakfast), 1 hour, 2 hour, 3.5 hour
A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.
0 hour (Pre breakfast), 1 hour, 2 hour, 3.5 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Intake
Time Frame: 3.5 hour following breakfast
Energy intake will be measured both during lab and outside of the laboratory when the participants are free-living. During lab, energy intake will be measured through ad-libitum feeding buffet where 20 minutes will be permitted to eat as much or as little as they desire, until 'comfortably full and satisfied', followed by post-feeding measurement of the remaining food.
3.5 hour following breakfast
Energy expenditure
Time Frame: Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit)
Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.
Activity recorded across day 1 standardisation and day 2 (lab visit and post lab visit)
Visual analogue scale for subjective ratings of appetite
Time Frame: 0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit)
Subjective appetite will be measured on mobile devices via a software which replicates a 100mm visual analogue scale. The scale is divided into subscales of different appetite perceptions including: hunger, fullness, desire to eat and prospective food consumption. This will be measured on a scale of 0-100 (0 - none at all) (100 - a lot).
0 hour (pre-breakfast), 1 hour, 2 hour, 3 hour, 4 hour (post breakfast during lab visit)
Acylated Ghrelin (Appetite hormone)
Time Frame: 0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast
Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.
0 hour (pre breakfast), 1 hour, 2 hour, and 3 hour post breakfast
PYY (Appetite hormone)
Time Frame: 0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast
Acylated Ghrelin will be measured from the venous samples taken during the post-prandial period following the standardised meal.
0 hour (pre-breakfast), 1 hour, 2 hour, and 3 hour post breakfast
Carbohydrate Oxidation
Time Frame: 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour post breakfast
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate carbohydrate oxidation.
0 hour (pre breakfast), 1 hour, 2 hour, 3 hour post breakfast
Fat Oxidation
Time Frame: 0 hour (pre breakfast), 1 hour, 2 hour, 3 hour
Investigators will be collecting expired air into Douglas bags, and measuring the VO2 and VCO2 concentration to calculate fat oxidation.
0 hour (pre breakfast), 1 hour, 2 hour, 3 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham Trent University

Collaborators

Loughborough University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 14, 2019

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WM_eFAST_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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