The Feasibility of Early Time-Restricted Eating in a Stud... | NCT05750277

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

NCT05750277

Sponsor

Nottingham Trent University

Status

Unknown status

Last Update Posted

Apr 24, 2023Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Time Restricted Feeding
Intermittent Fasting

Interventions

Evening Time-Restricted Eating

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2023Actual

Primary Completion Date

May 18, 2023Estimated

Completion Date

May 19, 2023Estimated

First Submitted Date

Feb 2, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Mar 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2023

Last Update Posted Date

Apr 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Mode, Principal Investigator, Nottingham Trent UniversityPrincipal Investigator

Lead Sponsor

Nottingham Trent UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Evening Time-Restricted Eating
Control	No Intervention	This group will maintain their habitual lifestyle for 4 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evening Time-Restricted Eating	Other	Eating between 8am-6pm.	Early Time-Restricted Eating

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Glucose	How their glucose concentrations change over the trial	4 weeks
Insulin	How their Insulin concentrations change over the trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Registered student

Exclusion Criteria:

Not taking any medication which is known to affect appetite

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham Trent University		Nottingham	Greater London	NG11 8NS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000093763	Intermittent Fasting

Ancestor Terms

ID	Term
D005215	Fasting
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

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Browse Branches

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