Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
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.
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:
NCT02369666
Study Brief:
Protocol Section:
NCT02369666