Protein MetabolismNCT03147001
Protein Ingestion Before Training Low
A study testing Protein ingestion in people with Protein Metabolism, run by University of Aarhus.
Trial summary
A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Protein ingestion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2016to 10 Jan 2017
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy well-trained triathletes or cyclists
- VO2max > 55 ml O2/kg/min
- Training and has been training more than 7 times a week the last 6 months.
Who cannot join
- VO2max < 55 ml O2/kg/min
- Has chronic disease
- has incjected with tracer on a previous occasion.
About this study
Official title: Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'.
A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.
- Conditions
- Protein Metabolism
- Being tested
- Protein ingestion, Non-caloric placebo ingestion
- Keywords
- Endurance exercise, Dietary protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein ingestionOther
A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
Non-caloric placebo ingestionOther
A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
| Study group | Role | What they receive |
|---|---|---|
| Protein ingestion | Experimental | Subjects ingested protein drinks Receives: Other: Protein ingestion |
| Placebo | Placebo comparator | Subjects ingested a non-caloric placebo drink Receives: Other: Non-caloric placebo ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein fractional synthetic rate (FSR)
Measured: FSR was measure over at time period of six hours
Secondary outcomes (3)
Tracer kinetics dilution model
A-V tracer dilution model was applied across the forearm.
Measured: six hours
Muscle signalling
Muscle signalling will be determined using western blotting in each muscle biopsy
Measured: Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.
Nitrogen excretion
nitrogen excretion is determined by Plasma and urinary carbide analysis as well as plasma NH4+.
Measured: Urine is collected during two periods. Collection period one: 12 hours prior to morning exercise. Collection period 2: During and four hours following exercise. Blood samples is drawn repeatedly from before to four hours after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start30 Apr 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein MetabolismStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, Team Denmark, Innovation Fund Denmark
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147001
- Sponsor's protocol ID
- 50968
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen MS, Holm L, Svart MV, Hjelholt AJ, Bengtsen MB, Dollerup OL, Dalgaard LB, Vendelbo MH, van Hall G, Moller N, Mikkelsen UR, Hansen M. Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial. J Int Soc Sports Nutr. 2020 Jan 28;17(1):7. doi: 10.1186/s12970-020-0338-z.
PubMed 31992300
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'.
- ClinicalTrials.gov ID
- NCT03147001
- Acronym / sponsor ID
- 50968
- Conditions
- Protein Metabolism
- Keywords
- Endurance exercise, Dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods, Team Denmark, Innovation Fund Denmark
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 10 May 2017 (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.
A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein ingestion | Experimental | Other: Protein ingestionSubjects ingested protein drinks |
| Placebo | Placebo comparator | Other: Non-caloric placebo ingestionSubjects ingested a non-caloric placebo drink |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy well-trained triathletes or cyclists
- VO2max > 55 ml O2/kg/min
- Training and has been training more than 7 times a week the last 6 months.
Key exclusion criteria (3 listed)
- VO2max < 55 ml O2/kg/min
- Has chronic disease
- has incjected with tracer on a previous occasion.
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 |
|---|---|---|
| Protein ingestionA protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised). | Other | Protein ingestion |
| Non-caloric placebo ingestionA placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised). | Other | Placebo |
Primary outcome
Muscle protein fractional synthetic rate (FSR)
Time frame: FSR was measure over at time period of six hours
3 secondary outcomes
Tracer kinetics dilution model
Time frame: six hours
Muscle signalling
Time frame: Determined in biopsies sampled before and immediatly after 90min exercise in addition to one and four hours after exercise.
Nitrogen excretion
Time frame: Urine is collected during two periods. Collection period one: 12 hours prior to morning exercise. Collection period 2: During and four hours following exercise. Blood samples is drawn repeatedly from before to four hours after exercise.
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 10 May 2017.
- Derived from this study: PubMed 31992300Larsen MS, Holm L, Svart MV, Hjelholt AJ, Bengtsen MB, Dollerup OL, Dalgaard LB, Vendelbo MH, van Hall G, Moller N, Mikkelsen UR, Hansen M. Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial. J Int Soc Sports Nutr. 2020 Jan 28;17(1):7. doi: 10.1186/s12970-020-0338-z.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Protein ingestion in people with Protein Metabolism, run by University of Aarhus.
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 3 inclusion and 3 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscle protein fractional synthetic rate (FSR) (time frame: FSR was measure over at time period of six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147001, which also lists 1 linked publication.
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 10 May 2017.