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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01424904
Eligibility Criteria:
Inclusion Criteria:
* Healthy males who are trained cyclists with a maximal oxygen uptake relative to body weight equal to or greater than 45 ml O2/kg/min.
* Subjects must be in the competitive phase of their annual training cycle.
* Between ages of 18-60
* Availability- commitment of the subject/expected participation in the study for 97 days.
Exclusion Criteria:
* Specific allergy to milk proteins (this is different from lactose intolerance)
* Use of immunosuppressive medication in the case of organ transplants
* Planned surgeries.
* Kidney disorders
* Use of antihypertensive medications
* Cardiovascular disease
* Abnormal BUN, creatinine, hemoglobin, or hematocrit
* Body weight greater than 285 pounds
* A protein-restricted diet
* Subjects currently using dry whey protein supplements, N-acetylcysteine, or alpha-lipoic acid supplements. The wash-out period is 1 month for any of these supplements.
* All medications that can interfere with muscle mass such as corticosteroids (e.g. prednisone), testosterone replacement or anabolic drugs such as Megace
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01424904
Study Brief:
Protocol Section:
NCT01424904