NCT05251103

Brief Summary

Background: Studies have revealed that time-restricted feeding affects the fat oxidation rate; however, its effects on the fat oxidation rate and hyperlipidemia following high-fat meals are unclear. This study investigated the effects of 5-day time-restricted feeding on the fat oxidation rate and postprandial lipemia following high fat meals. Methods: In this random crossover experimental study, eight healthy male adults were included each in the 5-day time-restricted feeding trial and the control trial. The meals of the time-restricted feeding trial were provided at 12:00, 16:00, and 20:00. The meals of the control trial were provided at 08:00, 14:00, and 20:00. The contents of the meals of both trials were the same, and the calories of the meals met the 24-hour energy requirement of the participants. After 5 days of the intervention, the participants consumed high-fat meals on the sixth day, and their physiological changes were determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 4, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 2, 2022

Last Update Submit

February 17, 2022

Conditions

Keywords

intermittent fasting

Outcome Measures

Primary Outcomes (5)

  • postprandial triglycerides concentrations

    postprandial triglycerides concentrations (mmol/L)

    on the 6th day

  • postprandial glucose concentrations

    postprandial glucose concentrations (mmol/L)

    on the 6th day

  • postprandial insulin concentrations

    postprandial insulin concentrations (pmol/L)

    on the 6th day

  • postprandial free fatty acid concentrations

    postprandial FFA concentrations (mmol/L)

    on the 6th day

  • postprandial glycerol concentrations

    postprandial glycerol concentrations (umol/L)

    on the 6th day

Secondary Outcomes (1)

  • fat oxidation

    on the 6th day

Study Arms (2)

time-restricted feeding trial

EXPERIMENTAL

The participants were divided into the time-restricted feeding trial for 5 days

Other: time-restricted feeding trial

control trial

EXPERIMENTAL

The participants in the control trial did not practice intermittent fasting methods

Other: time-restricted feeding trial

Interventions

The 5-day time-restricted feeding trial and the control trial. The meals of the time-restricted feeding trial were provided at 12:00, 16:00, and 20:00.

control trialtime-restricted feeding trial

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the participants had not undergone physical training;
  • they did not exercise regularly;
  • and they did not have any diseases that would prevent them from performing exercises, such as high blood pressure, hyperlipidemia, heart disease, joint disease, and osteoporosis.

You may not qualify if:

  • Undergone physical training;
  • Exercise regularly;
  • Have any diseases that would prevent them from performing exercises, such as high blood pressure, hyperlipidemia, heart disease, joint disease, and osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University of Sport

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Officials

  • ChihHui Chiu, PhD

    National Taiwan University of Sport

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 22, 2022

Study Start

June 4, 2021

Primary Completion

February 3, 2022

Study Completion

February 3, 2022

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations