PerformanceNCT03561337
Nutrient Supplementation Influences Mitochondria Adaptation
A study testing PROTEIN-CARBOHYDRATE and CARBOHDYRATE in people with Performance and Nutrition, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance, Nutrition, Protein
- What is being tested?
- PROTEIN-CARBOHYDRATE and CARBOHDYRATE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2013to 1 Jun 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- maximal oxygen uptake (VO2max) of >50ml O2 kg-1 min-1 for women and >55ml O2 kg-1 min-1 for men,
- running at least 3 times a week and
- running being the primarily training form
Who cannot join
- use of medicine
- diagnosed metabolic diseases
- injuries which hindered running and body mass index (BMI) < 25 kg m-2
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
Sport Science, Department of Public Health, Aarhus University
Aarhus, 8000
About this study
Official title: Effect of Whey Protein Hydrolysate on Adaptions to Endurance Training in Well-trained Runners
Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. The PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6 km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).
- Conditions
- Performance, Nutrition, Protein
- Being tested
- PROTEIN-CARBOHYDRATE, CARBOHDYRATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTEIN-CARBOHYDRATEDietary supplement
PRO before and PRO-CHO after training
CARBOHDYRATEDietary supplement
CHO before and after training
| Study group | Role | What they receive |
|---|---|---|
| PROTEIN-CARBOHYDRATE | Experimental | Intervention group receiving protein and carbohydrate supplement Receives: Dietary Supplement: PROTEIN-CARBOHYDRATE |
| CARBOHYDRATE | Placebo comparator | Intervention groups receiving carbohydrate supplement Receives: Dietary Supplement: CARBOHDYRATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
maximal oxygen uptake (L O2/min)
Measured: Change from week 1 to week 6
Secondary outcomes (6)
VDAC
Mitochondria target measured by western blotting
Measured: Change from week 1 to week 6
CytC
Mitochondria enzyme measured by western blotting
Measured: Change from week 1 to week 6
Performance
6 km trial test
Measured: Change from week 1 to week 6
COX-IV
Mitochondria target measured by western blotting
Measured: Change from week 1 to week 6
HSP60
Mitochondria target measured by western blotting
Measured: Change from week 1 to week 6
CD36
Fat transporter measured by western blotting
Measured: Change from week 1 to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Oct 2013
- Primary completion1 Feb 2014
- Study completion1 Jun 2014
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 PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- block randomized controlled intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561337
- Sponsor's protocol ID
- AURunners2017
- Status last verified
- May 2020
- First submitted
- 1 Dec 2017
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen M, Oxfeldt M, Larsen AE, Thomsen LS, Rokkedal-Lausch T, Christensen B, Rittig N, De Paoli FV, Bangsbo J, Ortenblad N, Madsen K. Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners. J Int Soc Sports Nutr. 2020 Sep 7;17(1):46. doi: 10.1186/s12970-020-00376-3.
PubMed 32894140
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Hydrolysate on Adaptions to Endurance Training in Well-trained Runners
- ClinicalTrials.gov ID
- NCT03561337
- Acronym / sponsor ID
- AURunners2017
- Conditions
- Performance, Nutrition, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 19 Jun 2018 (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.
Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. The PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6 km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- block randomized controlled intervention
| Arm | Type | Receives |
|---|---|---|
| PROTEIN-CARBOHYDRATE | Experimental | Dietary Supplement: PROTEIN-CARBOHYDRATEIntervention group receiving protein and carbohydrate supplement |
| CARBOHYDRATE | Placebo comparator | Dietary Supplement: CARBOHDYRATEIntervention groups receiving carbohydrate supplement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- maximal oxygen uptake (VO2max) of >50ml O2 kg-1 min-1 for women and >55ml O2 kg-1 min-1 for men,
- running at least 3 times a week and
- running being the primarily training form
Key exclusion criteria (3 listed)
- use of medicine
- diagnosed metabolic diseases
- injuries which hindered running and body mass index (BMI) < 25 kg m-2
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-CARBOHYDRATEPRO before and PRO-CHO after training | Dietary supplement | PROTEIN-CARBOHYDRATE |
| CARBOHDYRATECHO before and after training | Dietary supplement | CARBOHYDRATE |
Primary outcome
Maximal oxygen uptake
Time frame: Change from week 1 to week 6
maximal oxygen uptake (L O2/min)
6 secondary outcomes
VDAC
Time frame: Change from week 1 to week 6
CytC
Time frame: Change from week 1 to week 6
Performance
Time frame: Change from week 1 to week 6
COX-IV
Time frame: Change from week 1 to week 6
HSP60
Time frame: Change from week 1 to week 6
CD36
Time frame: Change from week 1 to week 6
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 14 May 2020.
- Derived from this study: PubMed 32894140Hansen M, Oxfeldt M, Larsen AE, Thomsen LS, Rokkedal-Lausch T, Christensen B, Rittig N, De Paoli FV, Bangsbo J, Ortenblad N, Madsen K. Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners. J Int Soc Sports Nutr. 2020 Sep 7;17(1):46. doi: 10.1186/s12970-020-00376-3.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTEIN-CARBOHYDRATE and CARBOHDYRATE in people with Performance and Nutrition, run by University of Aarhus at 2 sites in Denmark.
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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Maximal oxygen uptake (time frame: Change from week 1 to week 6). 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 NCT03561337, 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 14 May 2020.