Effect of Early Time-Restricted Eating on Appetite, Appetite-Regulatory Hormones and Energy Intake

NCT07500792 | Not Yet Recruiting

• 1 other identifier: 200250171
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised crossover study's primary aim is to investigate the effect of short-term fasting (eTRE) on subjective appetite and appetite-regulatory hormones (i.e., leptin, adiponectin, total glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP), total peptide YY (PYY), acylated ghrelin and Insulin). In addition, to examine if the one-day early time-restricted eating influences energy expenditure and ad libitum energy intake in the periods following the standard meal test. The researchers will compare normal eating with early Time-Restricted Eating (eTRE) in healthy men.

Conditions

Healthy Adult Male

Keywords

appetite-regulatory hormones; subjective appetite; early time-restricted eating; energy intake

Outcome Measures

Primary Outcomes (8)

• Change in Total Peptide-YY (PYY)

  The researchers will draw blood samples on day 2, at different time points during the trial, to measure the change in PYY levels. The area under the plasma concentration versus time curve (AUC) of PYY will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Acylated Ghrelin

  The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in acylated ghrelin levels. The area under the plasma concentration versus time curve (AUC) of acylated ghrelin will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Glucagon-Like Peptide-1 (GLP-1)

  The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in GLP-1 blood levels. Area under the plasma concentration versus time curve (AUC) of GLP-1 will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Leptin

  The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in Leptin levels. The area under the plasma concentration versus time curve (AUC) of Leptin will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Adiponectin

  The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in Adiponectin levels. The area under the plasma concentration versus time curve (AUC) of Adiponectin will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Gastric inhibitory polypeptide (GIP)

  The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in GIP levels. The area under the plasma concentration versus time curve (AUC) of GIP will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in Insulin

  The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in Insulin levels. The area under the plasma concentration versus time curve (AUC) of Insulin will be calculated using the trapezoidal rule.

  At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

• Change in subjective appetite sensations

  The researchers will assess the subjective appetite sensations using 100 mm visual analog scales (VAS) to measure appetite sensations (hunger, satiety, fullness, prospective food consumption, and desire to eat). The VAS are 100 mm long, with words anchored at each end expressing the most positive and negative ratings. Scores for each appetite construct range from 0-100.

  Will take place seven times over a two-hour period in Day1 and nine times in Day2 at 0 (baseline), 0.5, 1, 2, 3, 4, 5, 6 and 7 hours.

Secondary Outcomes (1)

• Energy Intake

  At 24 hours

Study Arms (2)

The normal diet experimental trial

EXPERIMENTAL

The participants will attend the lab in a fast state. They will have three meals in 12 hours, each providing 33% of their estimated energy needs.

Dietary Supplement: Normal diet; Other: instantaneous visual analogue scale (iVAS)

The eTRE diet experimental trial

EXPERIMENTAL

The participants will attend the lab in a fast state. They will have three meals in 16 hours, each providing 33% of their estimated energy needs.

Dietary Supplement: early Time-Restricted Eating (eTRE); Other: instantaneous visual analogue scale (iVAS)

Interventions

Normal diet DIETARY_SUPPLEMENT

The participants will consume three meals in 12 hours, each providing 33% of their estimated energy needs.

The normal diet experimental trial

early Time-Restricted Eating (eTRE) DIETARY_SUPPLEMENT

The participants will consume three meals in 6 hours, each providing 33% of their estimated energy needs.

The eTRE diet experimental trial

instantaneous visual analogue scale (iVAS) OTHER

Appetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be measured by visual analogue scales (VAS).

The eTRE diet experimental trial; The normal diet experimental trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18 years or older.
• BMI between 18.5 and 24.9 kg/m²
• Have stable body mass for at least three months (within ±2 kg).

You may not qualify if:

• Females
• People who are younger than 18 or older than 65 years old.
• Following a special diet (e.g. weight loss, vegetarian or vegan, etc.).
• Have food allergies related to the study.
• Smoking.
• Taking any medications.
• Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.

Sponsors & Collaborators

• University of Glasgow: lead
• University of Jazan: collaborator

Study Sites (1)

New Lister Building at Glasgow Royal Infirmary Glasgow, United Kingdom G31 2ER

Glasgow, G31 2ER, United Kingdom

Location

Study Officials

• James Dorling

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bothinah Jurabi

CONTACT

+447900334896; b.jurabi.1@research.gla.ac.uk

James Dorling

CONTACT

+441412016696; James.Dorling@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Human Nutrition, Principal Investigator

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available when the study is completed. Data will be preserved for 10 years.
• Access Criteria: Data will be shared via the repository deposit (Enlighten). Only signatories of end-user agreements can access and use shared data.

Locations

GB (1)