- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949709
Effects of Fasted- Versus Fed-exercise on Metabolic Health in Physically Active Adults
Effects of Fasted- Versus Fed-exercise on Glucose, Lipid and Blood Pressure Responses in Physically Active Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
In the 48 h prior to each main trial, participants were asked to refrain from performing any strenuous physical activity and from consuming alcohol/caffeine for 24 h prior to the main trials. A dietary record was completed 24 h before the first main trial and participants were asked to replicate this diet prior to their second main trial.
On main trial days, participants arrived at the laboratory between 8-9 am following a 12-hour fast. The entire experiment lasted a total of 375 minutes. After anthropometric measurements, participants rested on a bed for 20 minutes, during which expired gas samples were collected. During the initial 60 minutes, participants then either consumed a meal before exercise (ME) or after exercise (EM). Participants were asked to finish their breakfast within 10 minutes. In both the ME and EM treatments, participants walked on the treadmill at 6 km/h (for females) and 6.4 km/h (for males) for 30 minutes. Expired gas samples were collected during this time, heart rate (HR) was monitored every 5 minutes and ratings of perceived exertion (RPE) were recorded every 10 minutes. After a 2-hour rest, lunch was provided and consumed within 15 minutes. Participants then underwent a 3-hour observation period during the postprandial phase.
Measurement:
Blood pressure was measured every 30 minutes during the experiment using the OMRON HEM-7320 blood pressure monitor (OMRON Co., Ltd., Japan). Three measurements of blood pressure and pulse were taken, and these values were averaged to ensure that the two readings were within 5 mmHg of each other. If the two readings differed by more than 5 mmHg, additional readings were taken until the outlying measurement was excluded. Blood pressure and pulse were assessed with the individual in a semi-sitting position on the bed, ensuring the arm was properly positioned.
Blood samples were taken at 0, 30, 60, 75, 90, 105, 120, 150, 180, 195, 210, 225, 240, 255, 285, 315, 345, and 375 minutes. The samples were appropriately processed, frozen, and stored in the Exercise Physiology Laboratory refrigerator at the Gongguan Campus of National Taiwan Normal University.
Gas sampling was conducted five times during the experiment. Samples were collected upon arrival at the laboratory, during exercise, one hour after breakfast or exercise, one hour after lunch, and two hours after lunch to determine resting metabolic rate (RMR) and energy expenditure using substrate oxidation.
Subjective self-assessments of appetite and mood were taken at 0, 30, 60, 120, 180, 195, 255, 315, and 375 minutes using a Visual Analog Scale (VAS) ranging from 0 to 100.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20 and 45 years
- Regular walking habit of at least 7500 steps per day
- Engage in continuous walking for at least 20 minutes on 2 or more days per week
- Body Mass Index (BMI) ranging from 18.5 to 27 kg/m2
- No habits of heavy drinking or smoking, or have quit smoking for at least 6 months
- Absence of diabetes, cardiovascular, or metabolic-related disorders
- Not currently taking prescription drugs, over-the-counter medications, or other supplements that may affect blood sugar, blood pressure, or metabolic changes
- No current sports injuries or medical advice against exercise
- No significant weight fluctuations in the past three months (within ±3% of usual body weight)
- Not experiencing shift work or travel across time zones within the past six months
- No current plans to change lifestyle habits and willing to adhere to the requirements of the study
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: Fasted-exercise
Breakfast intake before 30 min walking
|
Breakfast intake before 30 min brisk walking on a treadmill
|
|
Experimental: Fed-exercise
30 min walking before breakfast intake
|
30 min brisk walking on a treadmill before breakfast intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose responses
Time Frame: 375 minutes
|
Changes in glucose concentrations between trials
|
375 minutes
|
|
Insulin responses
Time Frame: 375 minutes
|
Changes in insulin concentrations between trials
|
375 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Triacylglycerol responses
Time Frame: 375 minutes
|
Changes in Triacylglycerol concentrations between trials
|
375 minutes
|
|
Blood pressure
Time Frame: 375 minutes
|
Changes in blood pressure (e.g., diastolic and systolic blood pressure) between trials
|
375 minutes
|
|
Heart rate variability (HRV)
Time Frame: 375 minutes
|
Changes in heart rate variability between trials
|
375 minutes
|
|
Cognitive function
Time Frame: 375 minutes
|
Changes in cognitive function (e.g., Accuracy and reaction time) between trials
|
375 minutes
|
|
Visual Analog Scales (VAS)
Time Frame: 375 minutes
|
Changes in VAS (e.g, appetite and mood) between trials
|
375 minutes
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202310HM014-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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