LycoRed 40051 Product as a Countermeasure to Exercise Stress
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

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.
    

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
    

Intervention name(s): LycoRed (code 40051) product; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Mixture of tomato lycopene and carotenoids.; Contains MCT oil.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Lycopene; Exercise