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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05750277
Other study ID # NottinghamTU1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 19, 2023
Est. completion date May 19, 2023

Study information

Verified date April 2023
Source Nottingham Trent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study proposes to investigate the effect of a self-selected early time-restricted eating window in University students.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date May 19, 2023
Est. primary completion date May 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Registered student Exclusion Criteria: - Not taking any medication which is known to affect appetite

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evening Time-Restricted Eating
Eating between 8am-6pm.

Locations

Country Name City State
United Kingdom Nottingham Trent University Nottingham Greater London

Sponsors (1)

Lead Sponsor Collaborator
Nottingham Trent University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Secondary Glucose How their glucose concentrations change over the trial 4 weeks
Secondary Insulin How their Insulin concentrations change over the trial 4 weeks
Secondary HbA1C How their HbA1CA concentrations change over the trial 4 weeks
Secondary Body mass How their body mass changes over the trial 4 weeks
Secondary Blood pressure How blood pressure (systolic and diastolic) changes over the trial 4 weeks
Secondary Body fat percentage How their body fat percentage changes over the trial 4 weeks
Secondary Waist to hip ratio How their waist to hip ratio changes over the trial 4 weeks
Secondary 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. 4 weeks
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