Nutritional and Metabolic DiseasesNCT04688073
Effect of Muscle Damage After Downhill Running on Postprandial Lipids
A study testing Exercise and Rest in people with Nutritional and Metabolic Diseases and Lipemia, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases, Lipemia
- What is being tested?
- Exercise and Rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy, had not engaged in regular exercise or received any medication in the past 6 months
Who cannot join
- history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nutritional and Metabolic Diseases, Lipemia
- Being tested
- Exercise, Rest
- Keywords
- triglyceride, non-esterified fatty acids, eccentric exercise, cardiovascular disease
- Medical subject headings
- Nutritional and Metabolic Diseases, Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Running
RestBehavioural
sit and rest
| Study group | Role | What they receive |
|---|---|---|
| Downhill running | Experimental | Running at 60% VO2max on -15% slope for 30 min on a treadmill Receives: Behavioral: Exercise |
| Level running | Experimental | Running at 60% VO2max on level surface for 30 min on a treadmill Receives: Behavioral: Exercise |
| Control | Placebo comparator | Rest 30 min Receives: Behavioral: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
TG AUC
area under the curve for serum triglyceride concentrations within 6 hours after the high-fat meal
Measured: 6 hours
Secondary outcomes (1)
NEFA AUC
area under the curve for serum non-esterified fatty acid concentrations within 6 hours after the high-fat meal
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 May 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Kang Chang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688073
- Sponsor's protocol ID
- 201903HM011
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Damage After Downhill Running on Postprandial Lipids
- ClinicalTrials.gov ID
- NCT04688073
- Acronym / sponsor ID
- 201903HM011
- Conditions
- Nutritional and Metabolic Diseases, Lipemia
- Keywords
- triglyceride, non-esterified fatty acids, eccentric exercise, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Downhill running | Experimental | Behavioral: ExerciseRunning at 60% VO2max on -15% slope for 30 min on a treadmill |
| Level running | Experimental | Behavioral: ExerciseRunning at 60% VO2max on level surface for 30 min on a treadmill |
| Control | Placebo comparator | Behavioral: RestRest 30 min |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- generally healthy, had not engaged in regular exercise or received any medication in the past 6 months
Key exclusion criteria (1 listed)
- history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseRunning | Behavioural | Downhill running, Level running |
| Restsit and rest | Behavioural | Control |
Primary outcome
TG AUC
Time frame: 6 hours
area under the curve for serum triglyceride concentrations within 6 hours after the high-fat meal
1 secondary outcome
NEFA AUC
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Rest in people with Nutritional and Metabolic Diseases and Lipemia, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TG AUC (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.