Acute Time-Restricted Eating in Young Healthy Males

Sponsor
Nottingham Trent University (Other)
Overall Status
Completed
CT.gov ID
NCT05309798
Collaborator
Loughborough University (Other)
18
1
3
10.9
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Evening Fasting
  • Behavioral: Morning Fasting
  • Behavioral: Control
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The study design is a randomised, controlled, crossover design in which participants undertake three conditions in a randomised order with at least one week in between trials.The study design is a randomised, controlled, crossover design in which participants undertake three conditions in a randomised order with at least one week in between trials.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Acute Time-Restricted Eating on Energy Intake, Subjective Appetite and Glycaemic Control in Young Healthy Males
Actual Study Start Date :
Jan 14, 2019
Actual Primary Completion Date :
Dec 13, 2019
Actual Study Completion Date :
Dec 13, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Glycaemic Control [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'.

Secondary Outcome Measures

  1. Energy Intake [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.

  2. Energy expenditure [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.

  3. Visual analogue scale for subjective ratings of appetite [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).

  4. Acylated Ghrelin (Appetite hormone) [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.

  5. PYY (Appetite hormone) [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.

  6. Carbohydrate Oxidation [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.

  7. Fat Oxidation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nottingham Trent University Nottingham Nottinghamshire United Kingdom NG2 5BL

Sponsors and Collaborators

  • Nottingham Trent University
  • Loughborough University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
William Mode, Principle Investigator, Nottingham Trent University
ClinicalTrials.gov Identifier:
NCT05309798
Other Study ID Numbers:
  • WM_eFAST_2020
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by William Mode, Principle Investigator, Nottingham Trent University

Study Results

No Results Posted as of Apr 4, 2022