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Effect of Early Time-Restricted Eating on Appetite, Appetite-Regulatory Hormones and Energy Intake. 12 Crossover Design Short-Term
Clinical Trial NCT07500792 is an interventional study for Healthy Adult Male and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 12 participants. Led by University of Glasgow, this study is expected to complete by November 30, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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 an...Show More
Detailed Description
Screening visit At the screening visit, the participant will firstly meet with a researcher involved in the study. They will then be directed to the laboratory before being asked to sign the informed consent form followed by the Health Screening questionnaire. Further, participants will have height and weight measured by a researcher, and BMI will be subsequently calculated. Those who are eligible to participate will...Show More
Official Title
Effect of One Day Early Time-Restricted Eating (eTRE) on Appetite, Appetite-Regulatory Hormones and Energy Intake in Healthy Men Without Obesity.
Conditions
Healthy Adult MaleOther Study IDs
- 200250171
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-11-30
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
appetite-regulatory hormones
subjective appetite
early time-restricted eating
energy intake
subjective appetite
early time-restricted eating
energy intake
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalThe normal diet experimental trial 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. | Normal diet The participants will consume three meals in 12 hours, each providing 33% of their estimated energy needs. instantaneous visual analogue scale (iVAS) Appetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be measured by visual analogue scales (VAS). |
ExperimentalThe eTRE diet experimental trial 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. | early Time-Restricted Eating (eTRE) The participants will consume three meals in 6 hours, each providing 33% of their estimated energy needs. instantaneous visual analogue scale (iVAS) Appetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be measured by visual analogue scales (VAS). |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Total Peptide-YY (PYY) | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2, and 3 hours |
Change in Acylated Ghrelin | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
Change in Glucagon-Like Peptide-1 (GLP-1) | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
Change in Leptin | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
Change in Adiponectin | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
Change in Gastric inhibitory polypeptide (GIP) | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
Change in Insulin | The researchers will draw blood samples 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 (baseline), 0.5, 1, 2 and 3 hours. |
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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | At 24 hours |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
- 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).
- 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.
University of GlasgowUniversity of JazanStudy Responsible Party
James Dorling, PhD, Principal Investigator, Lecturer in Human Nutrition, Principal Investigator, University of Glasgow
Study Central Contact
Contact: Bothinah Jurabi, +447900334896, [email protected]
Contact: James Dorling, +441412016696, [email protected]
1 Study Locations in 1 Countries
New Lister Building at Glasgow Royal Infirmary Glasgow, United Kingdom G31 2ER, Glasgow, G31 2ER, United Kingdom