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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversity of Glasgow

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Normal diet

    Dietary supplement

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

  • early Time-Restricted Eating (eTRE)

    Dietary supplement

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

  • instantaneous visual analogue scale (iVAS)

    Other intervention

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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: The normal diet experimental trialExperimental treatment 2 interventions
Group B: The eTRE diet experimental trialExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

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

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.

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

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.

Time frame
At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
4

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.

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

Secondary outcomes

1

Energy Intake

To determine the amount of each food item consumed, the researchers will measure the difference in weight between before and after the meal. The researchers will use manufacturer details to determine energy consumption.

Time frame
At 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Glasgow

Lead sponsor

University of Jazan

Collaborator

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