Ketones & Mitochondrial Heteroplasmy

Completed · Early Phase 1

Conditions studied: MELAS Syndrome, Mitochondrial Diseases

In brief

The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA at position 3243 (A\>G). Subjects will be given supplemental medium chain triglycerides (MCTs) for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to treatment, at treatment initiation, and 6 months after initiation. The primary objective of the current study is to determine if there is a shift in heteroplasmy in patients harboring the 3243 A\>G mtDNA mutation to a more favorable (higher wild-type) profile while in a state of ketosis.

Key facts

Study ID

NCT01252979

Run by

The University of Texas Health Science Center, Houston

People needed

13

Starts

2010-12-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
• Subject is willing and able to comply with all trial requirements.
• Subject harbors the 3243 A>G mtDNA mutation at a level detectable in blood.
• Female subjects of child-bearing potential must not be pregnant. Female subjects of child-bearing potential (not surgically sterile or 2 years post-menopausal) must also agree to use appropriate contraceptive methods (abstinence, oral, injectable, implantable, or barrier) for the duration of the trial.
• Subject must not have diabetes mellitus.

You may not qualify if…

• Subject is currently participating or has participated within the last 2 months in any clinical trial involving treatment of mitochondrial disorders with MCT supplementation or induction of ketosis.
• Subject has a medical condition that could reasonably be exacerbated by ketone supplementation (including diabetes mellitus).
• Subject is unable to give reasonable informed consent/assent.
• Subject is a pregnant or nursing female.

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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