The Feasibility of Early Time-Restricted Eating in a Student Population

Intermittent Fasting Clinical Trial

Official title:

The Feasibility of Early Time-Restricted Eating in a Student Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05750277
• Other study ID #: NottinghamTU1
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intermittent Fasting
• Time Restricted Feeding

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