NCT01775384

Brief 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, inflammation, and oxidative stress) using both traditional and metabolomics-based outcome measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

January 2, 2013

Last Update Submit

January 22, 2013

Conditions

Exercise-induced InflammationExercise-induced Oxidative StressExercise-induced Immune Dysfunction

Keywords

InflammationOxidative stressImmune dysfunctionMetabolomics.

Outcome Measures

Primary Outcomes (1)

  • Metabolomics; change in metabolites over time

    GC-MS and LC-MS through Metabolon

    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

    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

    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

    18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running

Study Arms (2)

Nutrasorb

EXPERIMENTAL

Soy protein powder sorbed with polyphenols from blueberries and green tea extract

Dietary Supplement: Nutrasorb

Placebo

PLACEBO COMPARATOR

Soy protein isolate powder without polyphenols (with food coloring)

Dietary Supplement: Placebo

Interventions

NutrasorbDIETARY_SUPPLEMENT

from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)

Nutrasorb
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

  • 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.

    PMID: 23967286DERIVED

Related Links

MeSH Terms

Conditions

InflammationImmune System Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David C Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 25, 2013

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)