Time-restricted FeedingNCT05251103
The Effect of Different Methods for Modulating Postprandial Fat Oxidation on Postprandial Lipemia the Next Day
A study testing time-restricted feeding trial in people with Time-restricted Feeding and Postprandial Lipemia, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Time-restricted Feeding, Postprandial Lipemia
- What is being tested?
- time-restricted feeding trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jun 2021to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-restricted Feeding Increases Fat Oxidation Rate But Not Affect Postprandial Lipemia: a Crossover Trial
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.
Read the detailed description
The experiment was conducted over 6 days. On the first day, the participants arrived at the laboratory at 08:00 and quietly rested for 20 minutes in the supine position; gas analyzers were used to record their energy consumption. Subsequently, the participants were randomly allocated to the time-restricted feeding trial or the control trial. The meals of the time-restricted feeding trial were provided at 12:00, 16:00, and 20:00, and the participants were required to consume all the food during this time. The meals of the control trial were provided at 08:00, 14:00, and 20:00, but the consumption time was not limited. In addition to regular meals, a snack with approximately 200 calories was provided to the participants for consumption. The participants in the time-restricted feeding trial were only allowed to consume the snack from 12:00 to 20:00, whereas no restrictions were imposed on the control trial for snack consumption. The meals of the participants were provided by dieticians. Based on the results of the pretest, the calories of each meal met the daily energy requirement of the participants. The macronutrient consumption for TRF and CON were listed in table 1.
After experiment completion on the fifth day, the participants returned to the laboratory on the eighth day from 08:00 to 09:00. They rested for 10 minutes in the supine position, and gas analyzers were used to collect the gas data of the participants for 20 minutes. Next, a catheter was inserted into the forearm of each participant to collect fasting blood samples. After blood sample collection, the participants were provided with a specific high-fat meal. The participants rested quietly in the laboratory for 4 hours, and their blood lipid changes during this period were observed.
- Conditions
- Time-restricted Feeding, Postprandial Lipemia
- Being tested
- time-restricted feeding trial
- Keywords
- intermittent fasting
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-restricted feeding trialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| time-restricted feeding trial | Experimental | The participants were divided into the time-restricted feeding trial for 5 days Receives: Other: time-restricted feeding trial |
| control trial | Experimental | The participants in the control trial did not practice intermittent fasting methods Receives: Other: time-restricted feeding trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial triglycerides concentrations
postprandial triglycerides concentrations (mmol/L)
Measured: on the 6th day
postprandial glucose concentrations
postprandial glucose concentrations (mmol/L)
Measured: on the 6th day
postprandial insulin concentrations
postprandial insulin concentrations (pmol/L)
Measured: on the 6th day
postprandial free fatty acid concentrations
postprandial FFA concentrations (mmol/L)
Measured: on the 6th day
postprandial glycerol concentrations
postprandial glycerol concentrations (umol/L)
Measured: on the 6th day
Secondary outcomes (1)
fat oxidation
fasting fat oxidation rate (g/min-1)
Measured: on the 6th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start4 Jun 2021
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time-restricted FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Hui Chiu, National Taiwan Sport University
- Investigators
- ChihHui Chiu, PhD, Study chair, National Taiwan University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251103
- Sponsor's protocol ID
- 110-10
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Feeding Increases Fat Oxidation Rate But Not Affect Postprandial Lipemia: a Crossover Trial
- ClinicalTrials.gov ID
- NCT05251103
- Acronym / sponsor ID
- 110-10
- Conditions
- Time-restricted Feeding, Postprandial Lipemia
- Keywords
- intermittent fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The experiment was conducted over 6 days. On the first day, the participants arrived at the laboratory at 08:00 and quietly rested for 20 minutes in the supine position; gas analyzers were used to record their energy consumption. Subsequently, the participants were randomly allocated to the time-restricted feeding trial or the control trial. The meals of the time-restricted feeding trial were provided at 12:00, 16:00, and 20:00, and the participants were required to consume all the food during this time. The meals of the control trial were provided at 08:00, 14:00, and 20:00, but the consumption time was not limited. In addition to regular meals, a snack with approximately 200 calories was provided to the participants for consumption. The participants in the time-restricted feeding trial were only allowed to consume the snack from 12:00 to 20:00, whereas no restrictions were imposed on the control trial for snack consumption. The meals of the participants were provided by dieticians. Based on the results of the pretest, the calories of each meal met the daily energy requirement of the participants. The macronutrient consumption for TRF and CON were listed in table 1.
After experiment completion on the fifth day, the participants returned to the laboratory on the eighth day from 08:00 to 09:00. They rested for 10 minutes in the supine position, and gas analyzers were used to collect the gas data of the participants for 20 minutes. Next, a catheter was inserted into the forearm of each participant to collect fasting blood samples. After blood sample collection, the participants were provided with a specific high-fat meal. The participants rested quietly in the laboratory for 4 hours, and their blood lipid changes during this period were observed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| time-restricted feeding trial | Experimental | Other: time-restricted feeding trialThe participants were divided into the time-restricted feeding trial for 5 days |
| control trial | Experimental | Other: time-restricted feeding trialThe participants in the control trial did not practice intermittent fasting methods |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time-restricted feeding trialThe 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. | Other | control trial, time-restricted feeding trial |
Primary outcome
postprandial triglycerides concentrations
Time frame: on the 6th day
postprandial triglycerides concentrations (mmol/L)
postprandial glucose concentrations
Time frame: on the 6th day
postprandial glucose concentrations (mmol/L)
postprandial insulin concentrations
Time frame: on the 6th day
postprandial insulin concentrations (pmol/L)
postprandial free fatty acid concentrations
Time frame: on the 6th day
postprandial FFA concentrations (mmol/L)
postprandial glycerol concentrations
Time frame: on the 6th day
postprandial glycerol concentrations (umol/L)
1 secondary outcome
fat oxidation
Time frame: on the 6th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChihHui Chiu, PhD study chair
National Taiwan University of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time-restricted feeding trial in people with Time-restricted Feeding and Postprandial Lipemia, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial triglycerides concentrations (time frame: on the 6th day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.