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Effect of Muscle Damage After Downhill Running on Postprandial Lipids

Primary Purpose

Nutritional and Metabolic Diseases, Lipemia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Rest
Sponsored by
National Taiwan Sport University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutritional and Metabolic Diseases focused on measuring triglyceride, non-esterified fatty acids, eccentric exercise, cardiovascular disease

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University of Sport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Downhill running

Level running

Control

Arm Description

Running at 60% VO2max on -15% slope for 30 min on a treadmill

Running at 60% VO2max on level surface for 30 min on a treadmill

Rest 30 min

Outcomes

Primary Outcome Measures

TG AUC
area under the curve for serum triglyceride concentrations within 6 hours after the high-fat meal

Secondary Outcome Measures

NEFA AUC
area under the curve for serum non-esterified fatty acid concentrations within 6 hours after the high-fat meal

Full Information

First Posted
December 23, 2020
Last Updated
December 23, 2020
Sponsor
National Taiwan Sport University
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1. Study Identification

Unique Protocol Identification Number
NCT04688073
Brief Title
Effect of Muscle Damage After Downhill Running on Postprandial Lipids
Official Title
Effect of Muscle Damage After Downhill Running on Postprandial Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Sport University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases, Lipemia
Keywords
triglyceride, non-esterified fatty acids, eccentric exercise, cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Downhill running
Arm Type
Experimental
Arm Description
Running at 60% VO2max on -15% slope for 30 min on a treadmill
Arm Title
Level running
Arm Type
Experimental
Arm Description
Running at 60% VO2max on level surface for 30 min on a treadmill
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Rest 30 min
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Running
Intervention Type
Behavioral
Intervention Name(s)
Rest
Intervention Description
sit and rest
Primary Outcome Measure Information:
Title
TG AUC
Description
area under the curve for serum triglyceride concentrations within 6 hours after the high-fat meal
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
NEFA AUC
Description
area under the curve for serum non-esterified fatty acid concentrations within 6 hours after the high-fat meal
Time Frame
6 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National Taiwan University of Sport
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Muscle Damage After Downhill Running on Postprandial Lipids

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