Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02369666
Eligibility Criteria:
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).
* 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.
Exclusion Criteria:
* 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.
* 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.
\* For the purpose of this study one serving of vegetables or fruit is defined as: Vegetables
* 1 c raw leafy vegetable; ½ c cut-up raw or cooked vegetable; ½ c vegetable juice Fruit
* 1 med fruit; ¼ c dried fruit; ½ c fresh, frozen, or canned fruit; ½ c fruit juice
* For the purpose of this study, one unit of alcohol is defined as 12 oz (400 ml) of beer, 6 oz (200 ml) of wine or 1.5 oz (50 ml) of hard spirits.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02369666
Study Brief:
Protocol Section:
NCT02369666