- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251103
The Effect of Different Methods for Modulating Postprandial Fat Oxidation on Postprandial Lipemia the Next Day
Time-restricted Feeding Increases Fat Oxidation Rate But Not Affect Postprandial Lipemia: a Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 404
- National Taiwan University of Sport
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: time-restricted feeding trial
The participants were divided into the time-restricted feeding trial for 5 days
|
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.
|
|
Experimental: control trial
The participants in the control trial did not practice intermittent fasting methods
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postprandial triglycerides concentrations
Time Frame: on the 6th day
|
postprandial triglycerides concentrations (mmol/L)
|
on the 6th day
|
|
postprandial glucose concentrations
Time Frame: on the 6th day
|
postprandial glucose concentrations (mmol/L)
|
on the 6th day
|
|
postprandial insulin concentrations
Time Frame: on the 6th day
|
postprandial insulin concentrations (pmol/L)
|
on the 6th day
|
|
postprandial free fatty acid concentrations
Time Frame: on the 6th day
|
postprandial FFA concentrations (mmol/L)
|
on the 6th day
|
|
postprandial glycerol concentrations
Time Frame: on the 6th day
|
postprandial glycerol concentrations (umol/L)
|
on the 6th day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fat oxidation
Time Frame: on the 6th day
|
fasting fat oxidation rate (g/min-1)
|
on the 6th day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ChihHui Chiu, PhD, National Taiwan University of Sport
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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