Ketones & Mitochondrial Heteroplasmy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known pathogenic mutation in their mtDNA at position 3243 (A\>G). Subjects will be induced in to ketosis by administration of supplemental medium chain triglycerides (MCTs) for a period of 6 months. mtDNA heteroplasmy will be assessed 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) genotypic profile while in a state of ketosis.

Conditions

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MELAS Syndrome Mitochondrial Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medium Chain Triglyceride

Group Type EXPERIMENTAL

Medium-Chain Triglycerides

Intervention Type DIETARY_SUPPLEMENT

Subjects will take supplemental MCT oil 3 times a day for 6 months

Interventions

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Medium-Chain Triglycerides

Subjects will take supplemental MCT oil 3 times a day for 6 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
2. Subject is willing and able to comply with all trial requirements.
3. Subject harbors the 3243 A\>G mtDNA mutation at a level detectable in blood.
4. 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.
5. Subject must not have diabetes mellitus.

Exclusion Criteria

1. 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.
2. Subject has a medical condition that could reasonably be exacerbated by ketone supplementation (including diabetes mellitus).
3. Subject is unable to give reasonable informed consent/assent.
4. Subject is a pregnant or nursing female.

Eligible Sex

ALL

Accepts Healthy Volunteers

No