InflammationNCT02369666
LycoRed 40051 Product as a Countermeasure to Exercise Stress
A study testing LycoRed (code 40051) product in people with Inflammation, run by Appalachian State University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code 40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress during 24 hours recovery from a 2-h running… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- LycoRed (code 40051) product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female endurance runner (ages 18 to 45).
- Compete in long distance road races and are capable of running on a treadmill at marathon race pace for two hours (including 30 min of downhill running). Note: Preference will be given to runners who have completed a half-marathon or greater distance race in the previous year.
- At "low risk" status for cardiovascular disease (as determined with the screening questionnaire).
- Agree to train normally, stay weight stable, and avoid the use of large-dose vitamin/mineral supplements (above 100% of recommended dietary allowances), herbs, and all medications during the project.
- Agree to taper exercise prior to each of the two lab running sessions as if preparing for a long distance race.
Who cannot join
- Inability to comply with study requirements.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Weigh less than 110 pounds.
- Current, active history of coronary heart disease, stroke, cancer, diabetes, rheumatoid arthritis, high blood pressure, kidney disease, liver disease, blood disease, hormonal disease, or metabolic disease.
- History of cancer in the 5 years prior to the screening visit (except skin or cervical cancer that was successfully treated).
- Current use of any type of medication (or unwillingness to stop use of over-the-counter medications two weeks before the start of the study).
Show all 24Show fewer
- Use of any 'recreational substance' whether legal or illegal, by prescription or over the counter.
- Pregnant or nursing, or planning to be pregnant or nursing during the study.
- Use of vitamin/antioxidant supplements within 4 weeks prior to starting the study. For subjects using vitamin/antioxidant supplements, a 4-week wash out will be required prior to starting the study.
- Unwilling to follow dietary guidelines from the screening visit through the final visit as follows:
- no more than an average of 2 servings*/week of lycopene-rich foods (e.g. tomatoes and tomato products, including all sauces containing tomatoes that are contained in pizza, soups, etc., ketchup, vegetable juice with tomato, French salad dressing, mango, guava, watermelon, papaya, red grapefruit).
- no more than an average of 5 servings*/day of vegetables and fruit
- avoidance of antioxidant vitamin, mineral or herbal supplements including, but not limited to vitamin C, vitamin E, flavonoids, carotenoids, selenium, etc.
- Consumption of more than an average of 2 units of alcohol daily.**
- Known allergy to tomatoes or citrus fruits.
- Following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc. (Subjects should normally consume mixed diets).
- Current use of muscle enhancing supplements such as HMB, ATP and other similar muscle building agents.
- Current use of use of sodium bicarbonate or medications containing sodium bicarbonate such as Alka-Seltzer.
- Recent history of musculoskeletal trauma (fracture, strain, sprain, etc.) that has not fully healed prior to baseline testing.
- Planning to have surgery during the study.
- For the purpose of this study one serving of vegetables or fruit is defined as: Vegetables
- 1 c raw leafy vegetable; ½ c cut-up raw or cooked vegetable; ½ c vegetable juice Fruit
- 1 med fruit; ¼ c dried fruit; ½ c fresh, frozen, or canned fruit; ½ c fruit juice
- For the purpose of this study, one unit of alcohol is defined as 12 oz (400 ml) of beer, 6 oz (200 ml) of wine or 1.5 oz (50 ml) of hard spirits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Effects of 4-weeks Ingestion of LycoRed 40051 Product on Exercise-Induced Inflammation, Muscle Damage, and Oxidative Stress in Endurance Runners
The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code 40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress during 24 hours recovery from a 2-h running bout.
Read the detailed description
STUDY DESIGN
- Randomized-crossover, double-blind, placebo-controlled study, with N=20 endurance runners. (May start with up to 26 subjects to ensure that 20 subjects complete all study requirements). Subjects will ingest the supplement for 4 weeks prior to running 2 hours at high intensity, washout for 2 weeks, crossover and ingest the supplement for 4 weeks prior to running 2 hours at high intensity.
- 2 arms: LycoRed (code 40051) product and placebo.
- During the 3-day period prior to each running session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods and visible fats. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR).
- Exercise protocol: Subjects (overnight fasted) will run on laboratory treadmills at 70% VO2max (~marathon race pace) for 1.5 hours followed by 30 minutes of downhill running (10%) at the same intensity. The downhill running portion will induce delayed onset of muscle soreness (DOMS). The run sessions will occur at 7:00-9:00 am.
- Blood samples will be collected pre- and post-4 weeks supplementation, and immediately post-, 1-h post-, and 24-h post-exercise. DOMS will be measured using a 10-point Likert scale at each blood sampling time point.
STUDY PERFORMANCE
- Male and female endurance runners in the Kannapolis/Charlotte, NC metropolitan area will be recruited through mass advertising and direct email messages. Runners will also be recruited during the Expo event the day before the Charlotte Marathon.
- Study duration is 10 weeks, with 6 visits to the ASU-NCRC Human Performance Lab, two exercise sessions, and 10 blood samples.
- Visit 1: 0-week, pre-study, baseline testing and orientation, early morning; provide blood sample (overnight fasted). Subjects will sign the consent form, fill in the ACSM/AHA screening questionnaire, and complete a training history questionnaire. Subjects will be tested for VO2max (treadmill graded exercise test with metabolic measurement), and body composition (BodPod). Subjects will be given instructions for taking the supplements, and initiate supplementation (4-weeks) (with capsules contained in supplement trays to improve compliance). Subjects will be asked to maintain their normal training schedules, and will record weekly training distances in a log.
- Visit 2: 4-weeks, ~7:00 am, overnight fasted; provide blood pre- and post-running for 2 h (70% VO2max), and 1-h post run.
- Visit 3: ~7:00 am, overnight fasted, 24-h post-run: provide blood sample. Start 2-week washout period.
- Visit 4: 6-weeks, provide blood sample (~7:00 am, overnight fasted), crossover to opposite study arm, and start 4-week supplementation.
- Visit 5: 10-weeks, (~7:00 am, overnight fasted), provide blood pre- and post-running for 2 h (70% VO2max), and 1-h post run.
- Visit 6: 24-h post-run (~7:00 am, overnight fasted), provide final blood sample.
INVESTIGATIONAL PRODUCTS
- LycoRed (code 40051) product with mixture of selected carotenoids and phytochemicals in medium chain triglycerides (MCT).
- Placebo: Each softgel will be identical looking, containing the vehicle of MCT oil with all active ingredients removed.
- One serving (1 capsule) of the supplement will be consumed daily during the morning meal.
PRIMARY ENDPOINT
- Oxidative stress biomarkers
SECONDARY ENDPOINTS
- Inflammation biomarkers
- Muscle damage biomarkers
- Plasma lycopene, phytofluene, and phytoene
- Oxidative capacity
- Conditions
- Inflammation
- Being tested
- LycoRed (code 40051) product, Placebo
- Keywords
- Inflammation, Lycopene, Exercise
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycoRed (code 40051) productDietary supplement
Mixture of tomato lycopene and carotenoids.
PlaceboDietary supplement
Contains MCT oil.
| Study group | Role | What they receive |
|---|---|---|
| LycoRed (code 40051) product | Experimental | Dietary supplement, LycoRed (code 40051) product, experimental: Mixture of tomato-based carotenoids and phytochemicals in medium chain triglycerides (MCT). One capsule each day with the morning meal, for 4 weeks. Receives: Dietary Supplement: LycoRed (code 40051) product; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Dietary supplement placebo: Only MCT oil. One capsule each day with the morning meal, for 4 weeks. Receives: Dietary Supplement: LycoRed (code 40051) product; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise-induced oxidative stress
F2-isoprostanes.
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Secondary outcomes (8)
Change in plasma carotenoids, composite (lycopene, phytofluene, and phytoene)
Indicators of tomato paste product ingestion
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced muscle damage marker
Creatine kinase
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced muscle damage marker
Myoglobin
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced inflammation
C-reactive protein
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced inflammation, composite
six inflammatory cytokines, MSD panel (plasma IL-6, IL-8, IL-10, TNF-α, G-CSF, MCP-1)
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced oxidative stress
Protein carbonyls
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced oxidative stress
red blood cell glutathione
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in oxidative capacity
FRAP (Ferric Reducing Ability of Plasma)
Measured: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- LycoRed Ltd.
- Responsible party
- Sponsor
- Investigators
- David C. Nieman, DrPH, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369666
- Sponsor's protocol ID
- 15-0093
- Status last verified
- Jul 2015
- First submitted
- 30 Jan 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmed M, Henson DA, Sanderson MC, Nieman DC, Gillitt ND, Lila MA. The protective effects of a polyphenol-enriched protein powder on exercise-induced susceptibility to virus infection. Phytother Res. 2014 Dec;28(12):1829-36. doi: 10.1002/ptr.5208. Epub 2014 Aug 2.
PubMed 25088029Nieman DC, Shanely RA, Luo B, Meaney MP, Dew DA, Pappan KL. Metabolomics approach to assessing plasma 13- and 9-hydroxy-octadecadienoic acid and linoleic acid metabolite responses to 75-km cycling. Am J Physiol Regul Integr Comp Physiol. 2014 Jul 1;307(1):R68-74. doi: 10.1152/ajpregu.00092.2014. Epub 2014 Apr 23.
PubMed 24760997
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 4-weeks Ingestion of LycoRed 40051 Product on Exercise-Induced Inflammation, Muscle Damage, and Oxidative Stress in Endurance Runners
- ClinicalTrials.gov ID
- NCT02369666
- Acronym / sponsor ID
- 15-0093
- Conditions
- Inflammation
- Keywords
- Inflammation, Lycopene, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- LycoRed Ltd.
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- 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.
The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code 40051) product containing a mixture of tomato extract with carotenoids and phytochemicals by endurance runners attenuates inflammation, muscle damage and soreness, and oxidative stress during 24 hours recovery from a 2-h running bout.
Detailed description
STUDY DESIGN
- Randomized-crossover, double-blind, placebo-controlled study, with N=20 endurance runners. (May start with up to 26 subjects to ensure that 20 subjects complete all study requirements). Subjects will ingest the supplement for 4 weeks prior to running 2 hours at high intensity, washout for 2 weeks, crossover and ingest the supplement for 4 weeks prior to running 2 hours at high intensity.
- 2 arms: LycoRed (code 40051) product and placebo.
- During the 3-day period prior to each running session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods and visible fats. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR).
- Exercise protocol: Subjects (overnight fasted) will run on laboratory treadmills at 70% VO2max (~marathon race pace) for 1.5 hours followed by 30 minutes of downhill running (10%) at the same intensity. The downhill running portion will induce delayed onset of muscle soreness (DOMS). The run sessions will occur at 7:00-9:00 am.
- Blood samples will be collected pre- and post-4 weeks supplementation, and immediately post-, 1-h post-, and 24-h post-exercise. DOMS will be measured using a 10-point Likert scale at each blood sampling time point.
STUDY PERFORMANCE
- Male and female endurance runners in the Kannapolis/Charlotte, NC metropolitan area will be recruited through mass advertising and direct email messages. Runners will also be recruited during the Expo event the day before the Charlotte Marathon.
- Study duration is 10 weeks, with 6 visits to the ASU-NCRC Human Performance Lab, two exercise sessions, and 10 blood samples.
- Visit 1: 0-week, pre-study, baseline testing and orientation, early morning; provide blood sample (overnight fasted). Subjects will sign the consent form, fill in the ACSM/AHA screening questionnaire, and complete a training history questionnaire. Subjects will be tested for VO2max (treadmill graded exercise test with metabolic measurement), and body composition (BodPod). Subjects will be given instructions for taking the supplements, and initiate supplementation (4-weeks) (with capsules contained in supplement trays to improve compliance). Subjects will be asked to maintain their normal training schedules, and will record weekly training distances in a log.
- Visit 2: 4-weeks, ~7:00 am, overnight fasted; provide blood pre- and post-running for 2 h (70% VO2max), and 1-h post run.
- Visit 3: ~7:00 am, overnight fasted, 24-h post-run: provide blood sample. Start 2-week washout period.
- Visit 4: 6-weeks, provide blood sample (~7:00 am, overnight fasted), crossover to opposite study arm, and start 4-week supplementation.
- Visit 5: 10-weeks, (~7:00 am, overnight fasted), provide blood pre- and post-running for 2 h (70% VO2max), and 1-h post run.
- Visit 6: 24-h post-run (~7:00 am, overnight fasted), provide final blood sample.
INVESTIGATIONAL PRODUCTS
- LycoRed (code 40051) product with mixture of selected carotenoids and phytochemicals in medium chain triglycerides (MCT).
- Placebo: Each softgel will be identical looking, containing the vehicle of MCT oil with all active ingredients removed.
- One serving (1 capsule) of the supplement will be consumed daily during the morning meal.
PRIMARY ENDPOINT
- Oxidative stress biomarkers
SECONDARY ENDPOINTS
- Inflammation biomarkers
- Muscle damage biomarkers
- Plasma lycopene, phytofluene, and phytoene
- Oxidative capacity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LycoRed (code 40051) product | Experimental | Dietary Supplement: LycoRed (code 40051) product, Dietary Supplement: PlaceboDietary supplement, LycoRed (code 40051) product, experimental: Mixture of tomato-based carotenoids and phytochemicals in medium chain triglycerides (MCT). One capsule each day with the morning meal, for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: LycoRed (code 40051) product, Dietary Supplement: PlaceboDietary supplement placebo: Only MCT oil. One capsule each day with the morning meal, for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female endurance runner (ages 18 to 45).
- Compete in long distance road races and are capable of running on a treadmill at marathon race pace for two hours (including 30 min of downhill running). Note: Preference will be given to runners who have completed a half-marathon or greater distance race in the previous year.
- At "low risk" status for cardiovascular disease (as determined with the screening questionnaire).
- Agree to train normally, stay weight stable, and avoid the use of large-dose vitamin/mineral supplements (above 100% of recommended dietary allowances), herbs, and all medications during the project.
- Agree to taper exercise prior to each of the two lab running sessions as if preparing for a long distance race.
Key exclusion criteria (24 listed)
- Inability to comply with study requirements.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Weigh less than 110 pounds.
- Current, active history of coronary heart disease, stroke, cancer, diabetes, rheumatoid arthritis, high blood pressure, kidney disease, liver disease, blood disease, hormonal disease, or metabolic disease.
- History of cancer in the 5 years prior to the screening visit (except skin or cervical cancer that was successfully treated).
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 |
|---|---|---|
| LycoRed (code 40051) productMixture of tomato lycopene and carotenoids. | Dietary supplement | LycoRed (code 40051) product, Placebo |
| PlaceboContains MCT oil. | Dietary supplement | LycoRed (code 40051) product, Placebo |
Primary outcome
Change in exercise-induced oxidative stress
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
F2-isoprostanes.
8 secondary outcomes
Change in plasma carotenoids, composite (lycopene, phytofluene, and phytoene)
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced muscle damage marker
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced muscle damage marker
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced inflammation
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced inflammation, composite
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced oxidative stress
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in exercise-induced oxidative stress
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
Change in oxidative capacity
Time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise
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 16 Jul 2015.
- Results publication: PubMed 25088029Ahmed M, Henson DA, Sanderson MC, Nieman DC, Gillitt ND, Lila MA. The protective effects of a polyphenol-enriched protein powder on exercise-induced susceptibility to virus infection. Phytother Res. 2014 Dec;28(12):1829-36. doi: 10.1002/ptr.5208. Epub 2014 Aug 2.
- Results publication: PubMed 24760997Nieman DC, Shanely RA, Luo B, Meaney MP, Dew DA, Pappan KL. Metabolomics approach to assessing plasma 13- and 9-hydroxy-octadecadienoic acid and linoleic acid metabolite responses to 75-km cycling. Am J Physiol Regul Integr Comp Physiol. 2014 Jul 1;307(1):R68-74. doi: 10.1152/ajpregu.00092.2014. Epub 2014 Apr 23.
- North Carolina Research CampusLink provided by the sponsor.
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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.
David C. Nieman, DrPH principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LycoRed (code 40051) product in people with Inflammation, run by Appalachian State University at 1 site in United States.
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 5 inclusion and 24 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 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change in exercise-induced oxidative stress (time frame: baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise). 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 NCT02369666, which also lists 2 linked publications.
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 16 Jul 2015.