NCT02369666

Brief 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 bout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

January 30, 2015

Last Update Submit

July 15, 2015

Conditions

Inflammation

Keywords

InflammationLycopeneExercise

Outcome Measures

Primary Outcomes (1)

  • Change in exercise-induced oxidative stress

    F2-isoprostanes.

    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)

    baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise

  • Change in exercise-induced muscle damage marker

    baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise

  • Change in exercise-induced muscle damage marker

    baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise

  • Change in exercise-induced inflammation

    baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise

  • Change in exercise-induced inflammation, composite

    baseline and 4 weeks/pre-exercise, immediately post-exercise, 1-hour post-exercise, 24-hours post-exercise

  • +3 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: LycoRed (code 40051) productDietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Dietary supplement placebo: Only MCT oil. One capsule each day with the morning meal, for 4 weeks.

Dietary Supplement: LycoRed (code 40051) productDietary Supplement: Placebo

Interventions

LycoRed (code 40051) productDIETARY_SUPPLEMENT

Mixture of tomato lycopene and carotenoids.

LycoRed (code 40051) productPlacebo
PlaceboDIETARY_SUPPLEMENT

Contains MCT oil.

LycoRed (code 40051) productPlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (2)

  • 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.

    PMID: 25088029RESULT

  • Nieman 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.

    PMID: 24760997RESULT

Related Links

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • David C. Nieman, DrPH

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 24, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

US(1)