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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Time Restricted Feeding; Intermittent Fasting
• Intervention / Treatment: Other: Evening Time-Restricted Eating

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • Nottingham, Greater London, United Kingdom, NG11 8NS
      • Nottingham Trent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Registered student

Exclusion Criteria:

• Not taking any medication which is known to affect appetite

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time-Restricted Eating; 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.	Other: Evening Time-Restricted Eating; Eating between 8am-6pm.
No Intervention: Control; This group will maintain their habitual lifestyle for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nottingham Trent University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Anticipated): May 18, 2023
• Study Completion (Anticipated): May 19, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Appetite; Metabolism; Students
• Other Study ID Numbers: NottinghamTU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No