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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
      • Oslo, Norway, 0316
        • University of Oslo
      • Oslo, Norway
        • Norwegian Olympic Federation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Antioxidant-rich snacks
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.
Other: Control snacks
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian School of Sport Sciences
Norwegian Olympic Federation, Oslo, Norway

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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