Oxidative StressALTAXNCT03088891
Effect of an Antioxidant-rich Diet During Moderate Altitude Training
A study testing Antioxidant-rich snacks in people with Oxidative Stress and Adaptation Reaction, run by University of Oslo at 2 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 42 years
- Conditions the study is for
- Oxidative Stress, Adaptation Reaction, Inflammation
- What is being tested?
- Antioxidant-rich snacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2015to Nov 2015
- 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 16 to 42 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- National team athletes, summer endurance sports
Who cannot join
- Allergies in conflict with the intervention foods
- Use of medication that could affect training and performance
- Injuries that could affect training and performance
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Oxidative Stress, Adaptation Reaction, Inflammation
- Being tested
- Antioxidant-rich snacks, Control snacks
- Keywords
- altitude training, antioxidants, oxidative stress, elite athletes, inflammation, diet
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant-rich snacksOther
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)
Control snacksOther
Milkshake (Tine, Oslo, Norway), YT restitusjonsdrikk (Tine, Oslo, Norway), Bixit (Sætre, Oslo, Norway), Ritz (Mondelez, Oslo, Norway), White chololate (Freia, Oslo, Norway)
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant-rich snacks | Experimental | 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. Receives: Other: Antioxidant-rich snacks |
| Control snacks | Placebo comparator | 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. Receives: Other: Control snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in performance (sport specific tests will be aggregated to one outcome by the use of percent change)
Cycling: 10 000 m on a bike roller; Rowing: 2000 meter on Concept2-apparatus; Paddling: 1000 meter Concept2-apparatus; Swimming: 200 meter
Measured: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
Training adaptation
change in Vo2-max
Measured: Measured one week before, and one week after the moderate altitude training camp
Training adaptation for swimmers
For swimming only: 100 meter max speed
Measured: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
Secondary outcomes (19)
Change in biomarkers of inflammation
change in cytokine profile e.g. IL-6 ,TNF, CRP measured by multiplex technology
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 lean body mass
measured by DXA (iDXA; GE Healthcare)
Measured: 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
measured by DXA (iDXA; GE Healthcare)
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 fat mass
measured by DXA (iDXA; GE Healthcare)
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 body composition
measured by DXA (iDXA; GE Healthcare)
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 body weight
measured by standardized scale
Measured: 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)
measured by repeated 24 hour recalls
Measured: 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
e.g. FRAP, ORAC, dROM, isoprostanes measured by HPLC
Measured: 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
e.g. carotenoids, flavonoids measured by HPLC
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 whole blood gene expression
Fasting blood samples (PAX-tubes) and samples taken after physical stress test (PAX-tubes). RNA will be isolated and gene expression measured
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
Measured: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
Change hormones
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 micronutrients
e.g. iron status
Measured: 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
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 hemoglobin
CO-rebreathing-method
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 volume
CO-rebreathing-method
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 plasma volume
CO-rebreathing-method
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 lactate
Measured: 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
Training diary
Measured: Measured one week before, during (in week 1 and 3 of the camp) and one week after the moderate altitude training camp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startOct 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Oxidative StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Norwegian Olympic Federation, Oslo, Norway
- Responsible party
- Principal investigator, Rune Blomhoff, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088891
- Sponsor's protocol ID
- ALTAX
- Acronym
- ALTAX
- Status last verified
- Mar 2017
- First submitted
- 20 Sep 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Koivisto-Mork AE, Paur I, Paulsen G, Garthe I, Raastad T, Bastani NE, Blomhoff R, Bohn SK. Dietary Adjustments to Altitude Training in Elite Endurance Athletes; Impact of a Randomized Clinical Trial With Antioxidant-Rich Foods. Front Sports Act Living. 2020 Aug 26;2:106. doi: 10.3389/fspor.2020.00106. eCollection 2020.
PubMed 33345095
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03088891
- Acronym / sponsor ID
- ALTAX / ALTAX
- Conditions
- Oxidative Stress, Adaptation Reaction, Inflammation
- Keywords
- altitude training, antioxidants, oxidative stress, elite athletes, inflammation, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Norwegian Olympic Federation, Oslo, Norway
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Mar 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant-rich snacks | Experimental | Other: Antioxidant-rich snacksThe 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. |
| Control snacks | Placebo comparator | Other: Control snacksThe 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. |
Who may qualify
- Ages
- 16 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- National team athletes, summer endurance sports
Key exclusion criteria (3 listed)
- Allergies in conflict with the intervention foods
- Use of medication that could affect training and performance
- Injuries that could affect training and performance
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 |
|---|---|---|
| Antioxidant-rich snacksBama 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) | Other | Antioxidant-rich snacks |
| Control snacksMilkshake (Tine, Oslo, Norway), YT restitusjonsdrikk (Tine, Oslo, Norway), Bixit (Sætre, Oslo, Norway), Ritz (Mondelez, Oslo, Norway), White chololate (Freia, Oslo, Norway) | Other | Control snacks |
Primary outcome
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
Training adaptation
Time frame: Measured one week before, and one week after the moderate altitude training camp
change in Vo2-max
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
19 secondary outcomes
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 23 Mar 2017.
- Derived from this study: PubMed 33345095Koivisto-Mork AE, Paur I, Paulsen G, Garthe I, Raastad T, Bastani NE, Blomhoff R, Bohn SK. Dietary Adjustments to Altitude Training in Elite Endurance Athletes; Impact of a Randomized Clinical Trial With Antioxidant-Rich Foods. Front Sports Act Living. 2020 Aug 26;2:106. doi: 10.3389/fspor.2020.00106. eCollection 2020.
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
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 Antioxidant-rich snacks in people with Oxidative Stress and Adaptation Reaction, run by University of Oslo at 2 sites in Norway.
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 1 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 23 Mar 2017. 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 Norway. 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?
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). The study lists 3 primary outcomes in all. 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 NCT03088891, 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 23 Mar 2017.