- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03088891
Effect of an Antioxidant-rich Diet During Moderate Altitude Training (ALTAX)
March 19, 2017 updated by: Rune Blomhoff, University of Oslo
The Effect of an Increased Intake of Antioxidant-rich Foods on Training Adaptation, Redox-balance and Inflammation Among Elite Athletes During a Moderate Altitude Training Camp
Athletes, especially in endurance sports, are at increased risk of oxidative stress and inflammation-related diseases and injuries.
The production of reactive oxygen and nitrogen species (RONS) and inflammatory markers increase during exercise and especially during altitude training.
Antioxidant supplementation is commonly used among athletes in the belief that it prevents oxidative stress and oxidative damage.
A transient increase of RONS is however necessary to activate signaling cascades initiating training adaptation.
Antioxidant supplementation has been shown to inhibit the exercise effects in several independent studies, possibly by interfering/reducing the signal cascades initiated by RONS.
However, it is unknown whether a high intake of antioxidant rich foods can affect the amount of RONS, inflammation markers and/or training adaptation.
The investigators want to examine whether an increased intake of natural antioxidants in the form of antioxidant-rich foods fruits, vegetables and berries, in line with the official Norwegian dietary advice can affect antioxidant status, immune function and training adaptation associated with altitude training in Norwegian elite athletes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
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
-
-
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Oslo, Norway, 0316
- University of Oslo
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Oslo, Norway
- Norwegian Olympic Federation
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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
16 years to 42 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- National team athletes, summer endurance sports
Exclusion Criteria:
- Allergies in conflict with the intervention foods
- Use of medication that could affect training and performance
- Injuries that could affect training and performance
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antioxidant-rich snacks
The participants received antioxidant-rich snacks every day during 21 days of moderate altitude training (2300 meters above sea level).
The snack included fruits and vegetable smoothies, dark chocolate, walnuts, dried fruits and berries.
|
Bama Smoothies (Bama, Oslo, Norway), Freia Premium Dark Chocolate (Freia, Oslo, Norway), Walnuts (Eldorado, Norway), Dried fruits and berries (Cranberries, Gojiberries, apricots)(Bama, Oslo, Norway and Rema 1000, Norway)
|
Placebo Comparator: Control snacks
The participants received antioxidant-depleted snacks every day during 21 days of moderate altitude training (2300 meters above sea level).
The snack included milkshake, and other milk-based drinks, biscuits (both sweet and salty), white chocolate.
|
Milkshake (Tine, Oslo, Norway), YT restitusjonsdrikk (Tine, Oslo, Norway), Bixit (Sætre, Oslo, Norway), Ritz (Mondelez, Oslo, Norway), White chololate (Freia, Oslo, Norway)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in performance (sport specific tests will be aggregated to one outcome by the use of percent change)
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Cycling: 10 000 m on a bike roller; Rowing: 2000 meter on Concept2-apparatus; Paddling: 1000 meter Concept2-apparatus; Swimming: 200 meter
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Training adaptation
Time Frame: Measured one week before, and one week after the moderate altitude training camp
|
change in Vo2-max
|
Measured one week before, and one week after the moderate altitude training camp
|
Training adaptation for swimmers
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
For swimming only: 100 meter max speed
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in biomarkers of inflammation
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in cytokine profile e.g.
IL-6 ,TNF, CRP measured by multiplex technology
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in lean body mass
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by DXA (iDXA; GE Healthcare)
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Bone mineral density
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by DXA (iDXA; GE Healthcare)
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in fat mass
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by DXA (iDXA; GE Healthcare)
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in body composition
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by DXA (iDXA; GE Healthcare)
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in body weight
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by standardized scale
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Dietary intake (change in food and nutrient intake)
Time Frame: Measured one and three week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
measured by repeated 24 hour recalls
|
Measured one and three week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Change in antioxidant status
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
e.g.
FRAP, ORAC, dROM, isoprostanes measured by HPLC
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
biomarkers of antioxidant-rich foods
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
e.g.
carotenoids, flavonoids measured by HPLC
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Change in whole blood gene expression
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Fasting blood samples (PAX-tubes) and samples taken after physical stress test (PAX-tubes).
RNA will be isolated and gene expression measured
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Change in blood lipids
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
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Change hormones
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
|
Change in micronutrients
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
e.g. iron status
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change response to stress test
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
|
Change in hemoglobin
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
CO-rebreathing-method
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Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
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change in blood volume
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
CO-rebreathing-method
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
change in plasma volume
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
CO-rebreathing-method
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Change in lactate
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
|
Total training load
Time Frame: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
Training diary
|
Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
|
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
October 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
March 19, 2017
First Posted (Actual)
March 23, 2017
Study Record Updates
Last Update Posted (Actual)
March 23, 2017
Last Update Submitted That Met QC Criteria
March 19, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTAX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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