Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07500792

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexMale

Healthy volunteersAccepted

ConditionHealthy Adult Male

Full registry criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Treatments and study arms

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

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

Primary outcomes

Change in Total Peptide-YY (PYY)At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

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.

Change in Acylated GhrelinAt 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

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.

Change in Glucagon-Like Peptide-1 (GLP-1)At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

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.

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

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.

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

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.

Change in Gastric inhibitory polypeptide (GIP)At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.

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.

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

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.

Change in subjective appetite sensationsWill 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.

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.

Study locations

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

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