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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Normal diet
Dietary supplementThe participants will consume three meals in 12 hours, each providing 33% of their estimated energy needs.
early Time-Restricted Eating (eTRE)
Dietary supplementThe participants will consume three meals in 6 hours, each providing 33% of their estimated energy needs.
instantaneous visual analogue scale (iVAS)
Other interventionAppetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be measured by visual analogue scales (VAS).
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
Sponsors and contacts
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University of Glasgow
Lead sponsor
University of Jazan
Collaborator
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