- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688073
Effect of Muscle Damage After Downhill Running on Postprandial Lipids
All participants underwent three experimental trials, namely downhill running (DR), level running (LR), and the control (CON) in a cross-over design. Each trial lasted for 2 days. The participants were fed the same breakfast and lunch on day 1 in each trial. The participants arrived at the laboratory at 18:00 on day 1 and ran on the treadmill at 60% VO2max (downhill and level surface trials) or rested (CON trial) for 30 min. Subsequently, they were fed a standardized dinner (A meal box containing chicken, vegetables, and rice, 692 kcal, with 50% energy from carbohydrate, 32% from fat, and 18% from protein) within 20 min.
The participants returned to the laboratory at 07:30 on day 2 after an overnight fast. After baseline blood and gas samples were collected, the participants were fed a high-fat meal that included cereal, white bread, whipping cream, cheese, and butter. The high-fat meal provided fat 1.2 g/kg (65% energy), carbohydrate 1.1 g/kg (27% energy), protein 0.33 g/kg (8% energy), and 16.5 kcal/kg.
A 10-mL blood sample was collected from a forearm vein into nonheparinized tubes before and immediately after exercise or rest on day 1. On day 2, postprandial blood samples were collected from forearm veins into nonheparinized tubes by using an indwelling venous needle and a three-way stopcock. A 10-mL blood sample was collected before (0 h) and 0.5, 1, 2, 3, 4, 5, and 6 h after the high-fat meal.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 404
- National Taiwan University of Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- generally healthy, had not engaged in regular exercise or received any medication in the past 6 months
Exclusion Criteria:
- history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Downhill running
Running at 60% VO2max on -15% slope for 30 min on a treadmill
|
Running
|
EXPERIMENTAL: Level running
Running at 60% VO2max on level surface for 30 min on a treadmill
|
Running
|
PLACEBO_COMPARATOR: Control
Rest 30 min
|
sit and rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TG AUC
Time Frame: 6 hours
|
area under the curve for serum triglyceride concentrations within 6 hours after the high-fat meal
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NEFA AUC
Time Frame: 6 hours
|
area under the curve for serum non-esterified fatty acid concentrations within 6 hours after the high-fat meal
|
6 hours
|
Collaborators and Investigators
Sponsor
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
- 201903HM011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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