Time Restricted FeedingNCT05750277
The Feasibility of Early Time-Restricted Eating in a Student Population
A study testing Evening Time-Restricted Eating in people with Time Restricted Feeding and Intermittent Fasting, run by Nottingham Trent University at 1 site in United Kingdom.
Trial summary
This study proposes to investigate the effect of a self-selected early time-restricted eating window in University students. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Feeding, Intermittent Fasting
- What is being tested?
- Evening Time-Restricted Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2023to 19 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registered student
Who cannot join
- Not taking any medication which is known to affect appetite
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Trent University
Nottingham, Greater London, NG11 8NS
About this study
This study proposes to investigate the effect of a self-selected early time-restricted eating window in University students.
Read the detailed description
There were over 2.3 million students registered at Higher Education institutes in the UK. Early adulthood is a critical time for establishing self-care habits which will ultimately influence health outcomes later in adulthood and studies suggest that the overall health of students is poor relative to that of their age-matched peers not in education. Therefore, the investigators would like to assess the feasibility of adopting a novel, nutritional intervention in this important, understudied population.
Previous research has shown Early Time-Restricted Eating can reduce daily energy consumed and improve markers of health over time, in a range of populations. Therefore, the investigators are investigating how often participants can eat within an early 8 hour eating window, starting no earlier than 8am (finishing calorie intake by 4pm), or no later than 10am (finishing calorie intake by 6pm). The investigators will be measuring how often the participants can adhere to this eating window between Monday to Friday, with the study lasting 4 weeks in total. This is a feasibility study, so this study will investigate whether this intervention is achievable and what social barriers may exist which reduce adherence to this eating window. Participants will visit the laboratory on 3 occasions (at the start, halfway point, and at the end of the intervention) to measure any changes in health markers across the intervention. The lab visits will involve providing a finger-tip blood sample, and measuring body mass, blood pressure, and waist-to-hip circumference. Outside of the laboratory, participants are required to record their eating window on a mobile app and an investigator-created trial sheet. Further measures outside of the laboratory will include a weekly questionnaire and motivational correspondence via mobile text message.
- Conditions
- Time Restricted Feeding, Intermittent Fasting
- Being tested
- Evening Time-Restricted Eating
- Keywords
- Students, Metabolism, Appetite
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evening Time-Restricted EatingOther
Eating between 8am-6pm.
| Study group | Role | What they receive |
|---|---|---|
| Early Time-Restricted Eating | Experimental | This group will self-select their eating window as long as it is between 8am-6pm, and will aim to fast within this window as many occasions as possible between Monday-Friday for 4 weeks. Receives: Other: Evening Time-Restricted Eating |
| Control | No intervention | This group will maintain their habitual lifestyle for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful bouts of Early Time-Restricted Eating
Successful Early Time-Restricted Eating occasions will be recorded by the participant on a mobile device and an investigator-created trial sheet.
Measured: 4 weeks
Secondary outcomes (8)
Glucose
How their glucose concentrations change over the trial
Measured: 4 weeks
Insulin
How their Insulin concentrations change over the trial
Measured: 4 weeks
HbA1C
How their HbA1CA concentrations change over the trial
Measured: 4 weeks
Body mass
How their body mass changes over the trial
Measured: 4 weeks
Blood pressure
How blood pressure (systolic and diastolic) changes over the trial
Measured: 4 weeks
Body fat percentage
How their body fat percentage changes over the trial
Measured: 4 weeks
Waist to hip ratio
How their waist to hip ratio changes over the trial
Measured: 4 weeks
Appetite
Investigators will record appetite sensations, such as; hunger, fullness, prospective food consumption, desire to eat and nausea. Investigators will record these validated sensations to observe any changes across the trial. A visual analogue scale (100mm) will be digitised and sent to the participant by mobile text to record changes in the aforementioned appetitte sensations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start19 Apr 2023
- Primary completion18 May 2023 (estimated)
- Study completion19 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted FeedingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Mode, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750277
- Sponsor's protocol ID
- NottinghamTU1
- Status last verified
- Apr 2023
- First submitted
- 2 Feb 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Early Time-Restricted Eating in a Student Population
- ClinicalTrials.gov ID
- NCT05750277
- Acronym / sponsor ID
- NottinghamTU1
- Conditions
- Time Restricted Feeding, Intermittent Fasting
- Keywords
- Students, Metabolism, Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 18 May 2023 (estimated)
- Study completion
- 19 May 2023 (estimated)
- First posted
- 1 Mar 2023 (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 study proposes to investigate the effect of a self-selected early time-restricted eating window in University students.
Detailed description
There were over 2.3 million students registered at Higher Education institutes in the UK. Early adulthood is a critical time for establishing self-care habits which will ultimately influence health outcomes later in adulthood and studies suggest that the overall health of students is poor relative to that of their age-matched peers not in education. Therefore, the investigators would like to assess the feasibility of adopting a novel, nutritional intervention in this important, understudied population.
Previous research has shown Early Time-Restricted Eating can reduce daily energy consumed and improve markers of health over time, in a range of populations. Therefore, the investigators are investigating how often participants can eat within an early 8 hour eating window, starting no earlier than 8am (finishing calorie intake by 4pm), or no later than 10am (finishing calorie intake by 6pm). The investigators will be measuring how often the participants can adhere to this eating window between Monday to Friday, with the study lasting 4 weeks in total. This is a feasibility study, so this study will investigate whether this intervention is achievable and what social barriers may exist which reduce adherence to this eating window. Participants will visit the laboratory on 3 occasions (at the start, halfway point, and at the end of the intervention) to measure any changes in health markers across the intervention. The lab visits will involve providing a finger-tip blood sample, and measuring body mass, blood pressure, and waist-to-hip circumference. Outside of the laboratory, participants are required to record their eating window on a mobile app and an investigator-created trial sheet. Further measures outside of the laboratory will include a weekly questionnaire and motivational correspondence via mobile text message.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Time-Restricted Eating | Experimental | Other: Evening Time-Restricted EatingThis group will self-select their eating window as long as it is between 8am-6pm, and will aim to fast within this window as many occasions as possible between Monday-Friday for 4 weeks. |
| Control | No intervention | –This group will maintain their habitual lifestyle for 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Registered student
Key exclusion criteria (1 listed)
- Not taking any medication which is known to affect appetite
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 |
|---|---|---|
| Evening Time-Restricted EatingEating between 8am-6pm. | Other | Early Time-Restricted Eating |
Primary outcome
Successful bouts of Early Time-Restricted Eating
Time frame: 4 weeks
Successful Early Time-Restricted Eating occasions will be recorded by the participant on a mobile device and an investigator-created trial sheet.
8 secondary outcomes
Glucose
Time frame: 4 weeks
Insulin
Time frame: 4 weeks
HbA1C
Time frame: 4 weeks
Body mass
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Body fat percentage
Time frame: 4 weeks
Waist to hip ratio
Time frame: 4 weeks
Appetite
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evening Time-Restricted Eating in people with Time Restricted Feeding and Intermittent Fasting, run by Nottingham Trent University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful bouts of Early Time-Restricted Eating (time frame: 4 weeks). 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 24 Apr 2023.