Exercise-induced InflammationNCT01775384
Polyphenols, Exercise, and Metabolomics
A study testing Nutrasorb in people with Exercise-induced Inflammation and Exercise-induced Oxidative Stress, run by Appalachian State University at 1 site in United States.
Trial summary
Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced physiologic stress (i.e., immune dysfunction… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction
- What is being tested?
- Nutrasorb
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female endurance athletes; competitive runners or cyclists
- Capable of exercising for 2.5 h at a high intensity in the lab
- Ages 18-55
- Agree to train normally and stay weight stable.
- Agree to avoid the use of large dose vitamin/mineral supplements
- Agree to avoid herbs and medications that influence inflammation
Who cannot join
- Regularly take supplements or medicines known to effect inflammation.
- At moderate or high risk for cardiovascular disease.
- Younger than 18 or older than 55 years of age.
- No history of competing in long distance running and cycling races.
Trial locations and contacts
1 site in 1 country.
United States1 site
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach
Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both traditional and metabolomics-based outcome measures.
- Conditions
- Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction
- Being tested
- Nutrasorb, Placebo
- Keywords
- Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.
- Medical subject headings
- Inflammation, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrasorbDietary supplement
from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutrasorb | Experimental | Soy protein powder sorbed with polyphenols from blueberries and green tea extract Receives: Dietary Supplement: Nutrasorb |
| Placebo | Placebo comparator | Soy protein isolate powder without polyphenols (with food coloring) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics; change in metabolites over time
GC-MS and LC-MS through Metabolon
Measured: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Secondary outcomes (3)
Change in inflammation
CRP and a cytokine panel
Measured: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Change in oxidative stress
F2-isoprostanes, protein carbonyls, FRAP, ORAC
Measured: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Change in immune function
Anti-viral activity using virus-infected HeLa cells
Measured: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionDec 2012
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 Exercise-induced 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dole Food Company
- Responsible party
- Sponsor
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775384
- Sponsor's protocol ID
- 12-0134
- Status last verified
- Jan 2013
- First submitted
- 2 Jan 2013
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nieman DC, Gillitt ND, Knab AM, Shanely RA, Pappan KL, Jin F, Lila MA. Influence of a polyphenol-enriched protein powder on exercise-induced inflammation and oxidative stress in athletes: a randomized trial using a metabolomics approach. PLoS One. 2013 Aug 15;8(8):e72215. doi: 10.1371/journal.pone.0072215. eCollection 2013.
PubMed 23967286
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach
- ClinicalTrials.gov ID
- NCT01775384
- Acronym / sponsor ID
- 12-0134
- Conditions
- Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction
- Keywords
- Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Dole Food Company
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Jan 2013 (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.
Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both traditional and metabolomics-based outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrasorb | Experimental | Dietary Supplement: NutrasorbSoy protein powder sorbed with polyphenols from blueberries and green tea extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoy protein isolate powder without polyphenols (with food coloring) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female endurance athletes; competitive runners or cyclists
- Capable of exercising for 2.5 h at a high intensity in the lab
- Ages 18-55
- Agree to train normally and stay weight stable.
- Agree to avoid the use of large dose vitamin/mineral supplements
Key exclusion criteria (4 listed)
- Regularly take supplements or medicines known to effect inflammation.
- At moderate or high risk for cardiovascular disease.
- Younger than 18 or older than 55 years of age.
- No history of competing in long distance running and cycling races.
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 |
|---|---|---|
| Nutrasorbfrom blueberry and green tea extracts (2,136 mg/d gallic acid equivalents) | Dietary supplement | Nutrasorb |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Metabolomics; change in metabolites over time
Time frame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
GC-MS and LC-MS through Metabolon
3 secondary outcomes
Change in inflammation
Time frame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Change in oxidative stress
Time frame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Change in immune function
Time frame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
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 25 Jan 2013.
- Derived from this study: PubMed 23967286Nieman DC, Gillitt ND, Knab AM, Shanely RA, Pappan KL, Jin F, Lila MA. Influence of a polyphenol-enriched protein powder on exercise-induced inflammation and oxidative stress in athletes: a randomized trial using a metabolomics approach. PLoS One. 2013 Aug 15;8(8):e72215. doi: 10.1371/journal.pone.0072215. eCollection 2013.
- Lab web siteLink provided by the sponsor.
Related trials for Exercise-induced Inflammation
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Not yet recruiting
S-Acetyl Glutathione and Performance Recovery in Soccer
Performance Recovery, Exercise-induced Inflammation
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
Enrolling by invitationObservational study
The Effect of a Training Programme in the Variation of Fitness Parameters, Physiological, Hematological and Biochemical Indicators of Soccer Players During the Preseason Period
Athletic Performance, Soccer
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
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrasorb in people with Exercise-induced Inflammation and Exercise-induced Oxidative Stress, 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 6 inclusion and 4 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 25 Jan 2013. 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?
Metabolomics; change in metabolites over time (time frame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running). 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 NCT01775384, 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 25 Jan 2013.