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:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02284334
Eligibility Criteria:
Inclusion Criteria:
* Weight \> 15 kg
* Girls ≥ 11 years of age and/or who have achieved menarche must have a negative urine pregnancy test.
* Genetic and/or biochemical diagnosis of mitochondrial disease.
* Eat meals by mouth during the day.
Exclusion Criteria:
* Diabetes requiring insulin.
* Receive daytime total parenteral nutrition (TPN) and/or continuous enteral feedings.
* Prescribed dietary contraindication to mixed meal tolerance testing, e.g., ketogenic diet.
* Any investigational drug use within 30 days prior to enrollment.
* Pregnant or lactating females.
* Persons unable to fast for at least 4 hours.
* Persons who may be allergic to the test meals (shakes).
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-adherent to study schedules or procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
65 Years
Study:
NCT02284334
Study Brief:
Protocol Section:
NCT02284334