NCT04688073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 23, 2020

Last Update Submit

December 23, 2020

Conditions

Keywords

triglyceridenon-esterified fatty acidseccentric exercisecardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • TG AUC

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

    6 hours

Secondary Outcomes (1)

  • NEFA AUC

    6 hours

Study Arms (3)

Downhill running

EXPERIMENTAL

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

Behavioral: Exercise

Level running

EXPERIMENTAL

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

Behavioral: Exercise

Control

PLACEBO COMPARATOR

Rest 30 min

Behavioral: Rest

Interventions

ExerciseBEHAVIORAL

Running

Downhill runningLevel running
RestBEHAVIORAL

sit and rest

Control

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • generally healthy, had not engaged in regular exercise or received any medication in the past 6 months

You may not qualify if:

  • history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University of Sport

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Nutritional and Metabolic DiseasesHyperlipidemiasCardiovascular Diseases

Interventions

ExerciseRE1-silencing transcription factor

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

May 15, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations