- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03561337
Nutrient Supplementation Influences Mitochondria Adaptation
May 12, 2020 updated by: Mette Hansen, University of Aarhus
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University, Department for Public Health, Section for Sport Science
-
Aarhus, Denmark, 8000
- Sport Science, Department of Public Health, Aarhus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- use of medicine
- diagnosed metabolic diseases
- injuries which hindered running and body mass index (BMI) < 25 kg m-2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PROTEIN-CARBOHYDRATE
Intervention group receiving protein and carbohydrate supplement
|
PRO before and PRO-CHO after training
|
|
Placebo Comparator: CARBOHYDRATE
Intervention groups receiving carbohydrate supplement
|
CHO before and after training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal oxygen uptake
Time Frame: Change from week 1 to week 6
|
maximal oxygen uptake (L O2/min)
|
Change from week 1 to week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VDAC
Time Frame: Change from week 1 to week 6
|
Mitochondria target measured by western blotting
|
Change from week 1 to week 6
|
|
CytC
Time Frame: Change from week 1 to week 6
|
Mitochondria enzyme measured by western blotting
|
Change from week 1 to week 6
|
|
Performance
Time Frame: Change from week 1 to week 6
|
6 km trial test
|
Change from week 1 to week 6
|
|
COX-IV
Time Frame: Change from week 1 to week 6
|
Mitochondria target measured by western blotting
|
Change from week 1 to week 6
|
|
HSP60
Time Frame: Change from week 1 to week 6
|
Mitochondria target measured by western blotting
|
Change from week 1 to week 6
|
|
CD36
Time Frame: Change from week 1 to week 6
|
Fat transporter measured by western blotting
|
Change from week 1 to week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
December 1, 2017
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 12, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- AURunners2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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