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Completed

NCT Number: NCT05309798

Acute Time-Restricted Eating 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).

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Key information

Conditions

Obesity Prevention Behavior Fasting Feeding Behavior Intermittent Fasting

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham Trent University

Nottingham, Nottinghamshire, NG2 5BL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evening Fasting

Behavioral

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.

Morning Fasting

Behavioral

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.

Control

Behavioral

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.

Primary outcomes

  1. 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'.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Nottingham Trent University

Other

Collaborators

  • Loughborough University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2022
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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