NCT05750277

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

29 days

First QC Date

February 2, 2023

Last Update Submit

April 21, 2023

Conditions

Time Restricted FeedingIntermittent Fasting

Keywords

StudentsMetabolismAppetite

Outcome Measures

Primary Outcomes (1)

  • 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 (8)

  • Glucose

    4 weeks

  • Insulin

    4 weeks

  • HbA1C

    4 weeks

  • Body mass

    4 weeks

  • Blood pressure

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

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

Evening Time-Restricted EatingOTHER

Eating between 8am-6pm.

Early Time-Restricted Eating

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Registered student

You may not qualify if:

  • Not taking any medication which is known to affect appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Trent University

Nottingham, Greater London, NG11 8NS, United Kingdom

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2023

First Posted

March 1, 2023

Study Start

April 19, 2023

Primary Completion

May 18, 2023

Study Completion

May 19, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)