Total Nutrition Technology
Friday, December 12, 2014

Are you an endurance runner? ASU is conducting a paid study on the Effects of 4-weeks Ingestion of LycoRed 40051 Product on Exercise-Induced Inflammation, Muscle Damage, and Oxidative Stress in Endurance Runners.  Here are the details:

Principal Investigator: David C. Nieman, ASU Human Performance Laboratory at the North Carolina Research Campus, Kannapolis, NC

What is the purpose of this research?
Lycopene provides the red color in tomatoes, and helps to counter oxidative stress and inflammation in our bodies.  A few studies suggest that lycopene and other similar compounds in tomatoes (i.e., carotenoids) may help the athlete recovery better from hard workouts that cause muscle damage and soreness, oxidative stress, and inflammation.

The primary purpose of this study is to determine if 4-weeks ingestion of LycoRed (code 40051) product containing a mixture of tomato lycopene and carotenoids by endurance runners lessens inflammation, muscle damage and soreness, and oxidative stress during 24 hours recovery from an intensive 2-h running bout.

Why am I being invited to take part in this research?
You will be one of 20 to 26 subjects in this study at the ASU-NCRC Human Performance Lab in Kannapolis, NC.  You are being invited to take part in this research if you meet the criteria in this list:

Inclusion Criteria:
·         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).
Exclusion criteria (i.e., cannot join the study if you have any of these criteria):
·         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).
·         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.
·         Following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.  (Subjects should normally consume mixed diets).
·         Current use of muscle enhancing supplements such as HMB, ATP and other similar muscle building agents.
·         Current use of use of sodium bicarbonate or medications containing sodium bicarbonate such as Alka-Seltzer.
·         Recent history of musculoskeletal trauma (fracture, strain, sprain, etc.) that has not fully healed prior to baseline testing.
·         Planning to have surgery during the study.

 What will I be asked to do?The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC.  The total study duration is 10 weeks, with 6 visits to the ASU-NCRC Human Performance Lab that include two exercise sessions, and 10 blood samples.  The total amount of time you will be asked to volunteer for this study is about 14 hours at the Human Performance Laboratory (over the 10-week period).
In this study, you will ingest the LycoRed supplement or placebo for 4 weeks prior to running 2 hours at high intensity.  After a 2-week “washout” period, you will cross over to the opposite supplement, and repeat all procedures (i.e., ingest the LycoRed or placebo supplement for 4 weeks prior to running 2 hours at high intensity).  This figure summarizes the research design.

Will I be paid for taking part in the research?
We will pay you $600 for the time you volunteer while being in this study.

How do I sign up for the study or obtain more information?
Please send an email message to ASU-NCRC@appstate.edu, or call 704-250-5351.

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