Healthy Adult MaleNCT07500792
Effect of Early Time-Restricted Eating on Appetite, Appetite-Regulatory Hormones and Energy Intake
A study testing Normal diet, early Time-Restricted Eating (eTRE) and instantaneous visual analogue scale (iVAS) in people with Healthy Adult Male, run by University of Glasgow at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Normal diet, early Time-Restricted Eating (eTRE) and instantaneous visual analogue scale (iVAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
New Lister Building at Glasgow Royal Infirmary Glasgow, United Kingdom G31 2ER
Glasgow, G31 2ER
About this study
Official title: Effect of One Day Early Time-Restricted Eating (eTRE) on Appetite, Appetite-Regulatory Hormones and Energy Intake in Healthy Men Without Obesity
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.
Read the 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 be enrolled in the trial and will be invited for two experimental trials.
Those participants who are eligible will be asked to complete the International Physical Activity Questionnaire, to assess physical activity levels, a food preferences scale to examine how much they like the foods provided during experimental trials, and (should participants be eligible) participants will be provided with a food diary and scales that they must complete the day before their first and second experimental trials. Detailed instructions will be provided to participants on how to appropriately complete the food diary using the food scales.
Before experimental trials Participants will be instructed to complete two primary tasks prior to the experimental trials. First, participants will complete or follow a food diary. Specifically, 24 hours before the 2-day experimental trials, participants will complete a food diary, weighing and recording all food and beverage consumption. This is to ensure food and beverage intake is standardised in the 24 hours before the first experimental trial. Participants will also be instructed to fast from 20:30 the night before experimental trials.
Experimental trials Day 1 Participants will attend the lab at approximately 08:00 am. Participants will be fasting from 20:30 from the previous night (i.e., 12 hours without food or drink, except water). Once participants arrive, their weight will be recorded by a researcher, and they will rest until 09:00.
Normal diet In the normal diet experimental trial, the researcher will provide the standardised breakfast meal to participants at approximately 9:00 am. They will have 30 minutes to consume the meal. After this, participants will then rest in the metabolic research unit for the remaining 5.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit at the end of the trial (approximately 15:00; 7-hour trial in total), following a period of rest, they will then, at approximately 15:00, they will consume a standardised lunch, which they will have 30 minutes to consume. They will collect the standardised dinner to consume at home between 20:00 and 21.00 pm.
eTRE diet While in the eTRE diet experimental trial, they will consume the same meals but within a shorter time frame of six hours (9:00-15:00). The researcher will provide the standardised breakfast meal to participants at approximately 9:00 am. They will have 30 minutes to consume the meal. After this, participants will then rest in the metabolic research unit for the remaining 5.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit. Following a period of rest, they will then, at approximately 12:00 pm, they will consume a standardised lunch, which they will again have 30 minutes to consume. After this, participants will then rest in the metabolic research unit for the remaining 2.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit at the end of the trial (approximately 15:00; 7-hour trial in total), following a period of rest, they will then, at approximately 15:00 pm, they will consume a standardised dinner, which they will also have 30 minutes to consume. Water will be provided whenever the participant wishes. A researcher will be on hand to supervise the participant in the laboratory and will answer any questions the participant has.
The iVAS questionnaire will be administered to participants during the experimental trials (Normal/eTRE), which will take place seven times over a two-hour period. four of the questionnaires will be completed in the lab, while three will be taken home to fill out independently.
The design of the study is randomised and counter-balanced; half of the participants will complete the normal diet first, while the other half will complete the eTRE diet first.
Day 2 On the second day of the experimental trials, participants will arrive at the laboratory at approximately 08:00 having fasted (participants instructed not to eat or drink [except water] since 21:00 from the night of the normal diet experimental day and since 16:00 of the eTRE diet experimental day). A researcher trained in phlebotomy will insert a cannula into the antecubital vein. After about one hour to acclimatise to the cannula, a fasting blood sample will be collected, and data collection will begin.
Blood samples will be collected at various points. The investigators will first draw approximately 2 ml of excess blood and saline for each blood sample that may remain in the cannula. Following this, the investigators will withdraw 11.7 ml of blood for testing.
After the collection of each blood sample, measurements of the volume of oxygen consumed (V̇O2) and the volume of carbon dioxide produced (V̇CO2) will be recorded every 30 seconds for a total duration of 10-15 minutes. This will be achieved by the computerised open-circuit ventilated hood system (Quark RMR®, COSMED, Italy). Participants will be asked to lie supine and still. Once comfortable, a clear plastic canopy will be placed over the participant's head, and V̇O2 and V̇CO2 will be recorded every 30 seconds. Measurement values will be used to calculate the rate of fat and carbohydrate oxidation and the thermic effect of food through the tests. Volume and gas calibrations of the apparatus will be performed before measurement.
Participants will have a standardised breakfast (mixed meal tolerance test [1500 kcal]), consisting of croissants, butter, and milkshake.
Additionally, participants will be provided with an ad libitum buffet lunch in a private dining room under researcher supervision, as well as an ad libitum buffet dinner to take home and consume before going to bed. The lunch meal will include white and brown bread, butter, wafer chicken, mixed salad, yogurt, apples, bananas, muffins, and wine gums. The dinner meal will feature chicken, white and brown bread, cheese, butter, yogurt, nuts or granola, milk, chocolate chip cookies, apples and bananas. Participants will attend the laboratory for a supervised ad libitum buffet lunch. They will be seated individually and given a maximum of 30 minutes to consume the meal. All foods will be weighed before and after consumption to determine total energy intake. This lunch meal serves as the primary measure of energy intake in the study. More than enough items will be provided for the expected consumption, and if participants need more food items, they will be given them upon request. In addition, in the dinner meal, participants will be provided with ad libitum buffet takeaway dinner. They will be instructed to consume as much or as little of this meal as they wish, at any time before going to bed. It is important to inform them that they are not allowed to eat any of our foods for breakfast, the morning after Day 2. To determine the amount of each food item consumed, the investigators will measure the difference in weight between before and after the meal. The investigators will also use manufacturer details to determine energy and macronutrient consumption. Participants will return all remaining food packaging and containers the following day or by pre-arranged collection.
During this, appetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be assessed using 100 mm Visual analogue scales (iVAS) at baseline, 0.5, 1, 2, 3, 4 and 5 hours. Additionally, a scale will be provided before and after the buffet dinner, resulting in a total of nine assessments. These scales are 100 mm long, with words anchored at each end expressing the most extreme appetite sensations.
Participants will then rest in the metabolic research unit, and they will be able to consume water ad libitum and will be able to bring laptops/tablets and books.
Finally, participants will be provided with the food diary they completed before the experimental trials (i.e., normal diet day and eTRE diet day) and the food scales.
In between 2-day experimental trials On the day before their experimental trials (i.e., normal diet day and eTRE diet day), participants will be asked to follow the food diary they completed 24 hours prior to each trial. They will also be instructed to fast from 8:30 PM the night before the experimental trials (i.e., no food or drink, except water, after 20:30). On the second day of the experimental trials. Participants should not eat or drink (except for water) after 9:00 pm the night of the normal diet experimental day and since 16:00 of the eTRE diet experimental day). Additionally, participants will be instructed to maintain their usual diet and daily routine and not to introduce any dietary changes or alterations to their routine that might affect appetite or appetite-related hormone responses. Participants will have the opportunity to contact the researcher at any point if they have questions.
- Conditions
- Healthy Adult Male
- Being tested
- Normal diet, early Time-Restricted Eating (eTRE), instantaneous visual analogue scale (iVAS)
- Keywords
- appetite-regulatory hormones, subjective appetite, early time-restricted eating, energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: early Time-Restricted Eating (eTRE); Other: instantaneous visual analogue scale (iVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jazan
- Responsible party
- Principal investigator, James Dorling, PhD, University of Glasgow
- Investigators
- James Dorling, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500792
- Sponsor's protocol ID
- 200250171
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The stored data will be anonymous and follow the guidelines of the General Data Protection Regulation enforced in May 2018. Hard copies of participant information forms, including consent forms and dietary intake records, will be kept in locked filing cabinets. Keys to the filing cabinets will only be available to the primary investigator. All databases will be password protected and stored on a university computer with firewalls. Participants' identifiable data will be stored in a locked cabinet. Digital data will be stored anonymously within the server of the University of Glasgow. This project's Principal Investigator will be responsible for sharing the research data. Data will be preserved in Enlighten, the official online repository of Glasgow University's research output.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of One Day Early Time-Restricted Eating (eTRE) on Appetite, Appetite-Regulatory Hormones and Energy Intake in Healthy Men Without Obesity
- ClinicalTrials.gov ID
- NCT07500792
- Acronym / sponsor ID
- 200250171
- Conditions
- Healthy Adult Male
- Keywords
- appetite-regulatory hormones, subjective appetite, early time-restricted eating, energy intake
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- University of Jazan
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 be enrolled in the trial and will be invited for two experimental trials.
Those participants who are eligible will be asked to complete the International Physical Activity Questionnaire, to assess physical activity levels, a food preferences scale to examine how much they like the foods provided during experimental trials, and (should participants be eligible) participants will be provided with a food diary and scales that they must complete the day before their first and second experimental trials. Detailed instructions will be provided to participants on how to appropriately complete the food diary using the food scales.
Before experimental trials Participants will be instructed to complete two primary tasks prior to the experimental trials. First, participants will complete or follow a food diary. Specifically, 24 hours before the 2-day experimental trials, participants will complete a food diary, weighing and recording all food and beverage consumption. This is to ensure food and beverage intake is standardised in the 24 hours before the first experimental trial. Participants will also be instructed to fast from 20:30 the night before experimental trials.
Experimental trials Day 1 Participants will attend the lab at approximately 08:00 am. Participants will be fasting from 20:30 from the previous night (i.e., 12 hours without food or drink, except water). Once participants arrive, their weight will be recorded by a researcher, and they will rest until 09:00.
Normal diet In the normal diet experimental trial, the researcher will provide the standardised breakfast meal to participants at approximately 9:00 am. They will have 30 minutes to consume the meal. After this, participants will then rest in the metabolic research unit for the remaining 5.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit at the end of the trial (approximately 15:00; 7-hour trial in total), following a period of rest, they will then, at approximately 15:00, they will consume a standardised lunch, which they will have 30 minutes to consume. They will collect the standardised dinner to consume at home between 20:00 and 21.00 pm.
eTRE diet While in the eTRE diet experimental trial, they will consume the same meals but within a shorter time frame of six hours (9:00-15:00). The researcher will provide the standardised breakfast meal to participants at approximately 9:00 am. They will have 30 minutes to consume the meal. After this, participants will then rest in the metabolic research unit for the remaining 5.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit. Following a period of rest, they will then, at approximately 12:00 pm, they will consume a standardised lunch, which they will again have 30 minutes to consume. After this, participants will then rest in the metabolic research unit for the remaining 2.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit at the end of the trial (approximately 15:00; 7-hour trial in total), following a period of rest, they will then, at approximately 15:00 pm, they will consume a standardised dinner, which they will also have 30 minutes to consume. Water will be provided whenever the participant wishes. A researcher will be on hand to supervise the participant in the laboratory and will answer any questions the participant has.
The iVAS questionnaire will be administered to participants during the experimental trials (Normal/eTRE), which will take place seven times over a two-hour period. four of the questionnaires will be completed in the lab, while three will be taken home to fill out independently.
The design of the study is randomised and counter-balanced; half of the participants will complete the normal diet first, while the other half will complete the eTRE diet first.
Day 2 On the second day of the experimental trials, participants will arrive at the laboratory at approximately 08:00 having fasted (participants instructed not to eat or drink [except water] since 21:00 from the night of the normal diet experimental day and since 16:00 of the eTRE diet experimental day). A researcher trained in phlebotomy will insert a cannula into the antecubital vein. After about one hour to acclimatise to the cannula, a fasting blood sample will be collected, and data collection will begin.
Blood samples will be collected at various points. The investigators will first draw approximately 2 ml of excess blood and saline for each blood sample that may remain in the cannula. Following this, the investigators will withdraw 11.7 ml of blood for testing.
After the collection of each blood sample, measurements of the volume of oxygen consumed (V̇O2) and the volume of carbon dioxide produced (V̇CO2) will be recorded every 30 seconds for a total duration of 10-15 minutes. This will be achieved by the computerised open-circuit ventilated hood system (Quark RMR®, COSMED, Italy). Participants will be asked to lie supine and still. Once comfortable, a clear plastic canopy will be placed over the participant's head, and V̇O2 and V̇CO2 will be recorded every 30 seconds. Measurement values will be used to calculate the rate of fat and carbohydrate oxidation and the thermic effect of food through the tests. Volume and gas calibrations of the apparatus will be performed before measurement.
Participants will have a standardised breakfast (mixed meal tolerance test [1500 kcal]), consisting of croissants, butter, and milkshake.
Additionally, participants will be provided with an ad libitum buffet lunch in a private dining room under researcher supervision, as well as an ad libitum buffet dinner to take home and consume before going to bed. The lunch meal will include white and brown bread, butter, wafer chicken, mixed salad, yogurt, apples, bananas, muffins, and wine gums. The dinner meal will feature chicken, white and brown bread, cheese, butter, yogurt, nuts or granola, milk, chocolate chip cookies, apples and bananas. Participants will attend the laboratory for a supervised ad libitum buffet lunch. They will be seated individually and given a maximum of 30 minutes to consume the meal. All foods will be weighed before and after consumption to determine total energy intake. This lunch meal serves as the primary measure of energy intake in the study. More than enough items will be provided for the expected consumption, and if participants need more food items, they will be given them upon request. In addition, in the dinner meal, participants will be provided with ad libitum buffet takeaway dinner. They will be instructed to consume as much or as little of this meal as they wish, at any time before going to bed. It is important to inform them that they are not allowed to eat any of our foods for breakfast, the morning after Day 2. To determine the amount of each food item consumed, the investigators will measure the difference in weight between before and after the meal. The investigators will also use manufacturer details to determine energy and macronutrient consumption. Participants will return all remaining food packaging and containers the following day or by pre-arranged collection.
During this, appetite ratings (hunger, satisfaction, fullness, prospective food consumption and desire to eat) will be assessed using 100 mm Visual analogue scales (iVAS) at baseline, 0.5, 1, 2, 3, 4 and 5 hours. Additionally, a scale will be provided before and after the buffet dinner, resulting in a total of nine assessments. These scales are 100 mm long, with words anchored at each end expressing the most extreme appetite sensations.
Participants will then rest in the metabolic research unit, and they will be able to consume water ad libitum and will be able to bring laptops/tablets and books.
Finally, participants will be provided with the food diary they completed before the experimental trials (i.e., normal diet day and eTRE diet day) and the food scales.
In between 2-day experimental trials On the day before their experimental trials (i.e., normal diet day and eTRE diet day), participants will be asked to follow the food diary they completed 24 hours prior to each trial. They will also be instructed to fast from 8:30 PM the night before the experimental trials (i.e., no food or drink, except water, after 20:30). On the second day of the experimental trials. Participants should not eat or drink (except for water) after 9:00 pm the night of the normal diet experimental day and since 16:00 of the eTRE diet experimental day). Additionally, participants will be instructed to maintain their usual diet and daily routine and not to introduce any dietary changes or alterations to their routine that might affect appetite or appetite-related hormone responses. Participants will have the opportunity to contact the researcher at any point if they have questions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The normal diet experimental trial | Experimental | Dietary Supplement: Normal diet, Other: instantaneous visual analogue scale (iVAS)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. |
| The eTRE diet experimental trial | Experimental | Dietary Supplement: early Time-Restricted Eating (eTRE), Other: instantaneous visual analogue scale (iVAS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dietThe participants will consume three meals in 12 hours, each providing 33% of their estimated energy needs. | Dietary supplement | The normal diet experimental trial |
| early Time-Restricted Eating (eTRE)The participants will consume three meals in 6 hours, each providing 33% of their estimated energy needs. | Dietary supplement | The eTRE diet experimental trial |
| 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). | Other | The eTRE diet experimental trial, The normal diet experimental trial |
Primary outcome
Change in Total Peptide-YY (PYY)
Time frame: 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 Ghrelin
Time frame: 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 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)
Time frame: 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 Leptin
Time frame: 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 Leptin levels. The area under the plasma concentration versus time curve (AUC) of Leptin will be calculated using the trapezoidal rule.
Change in Adiponectin
Time frame: 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 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)
Time frame: 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 Insulin
Time frame: 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 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 sensations
Time frame: 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.
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.
1 secondary outcome
Energy Intake
Time frame: At 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. The stored data will be anonymous and follow the guidelines of the General Data Protection Regulation enforced in May 2018. Hard copies of participant information forms, including consent forms and dietary intake records, will be kept in locked filing cabinets. Keys to the filing cabinets will only be available to the primary investigator. All databases will be password protected and stored on a university computer with firewalls. Participants' identifiable data will be stored in a locked cabinet. Digital data will be stored anonymously within the server of the University of Glasgow. This project's Principal Investigator will be responsible for sharing the research data. Data will be preserved in Enlighten, the official online repository of Glasgow University's research output.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Dorling principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet, early Time-Restricted Eating (eTRE) and instantaneous visual analogue scale (iVAS) in people with Healthy Adult Male, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bothinah Jurabi (+447900334896, b.jurabi.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Peptide-YY (PYY) (time frame: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.