Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-01-22

Brief Summary

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The purpose of the study is to determine if an oral ketone beverage is safe and well-tolerated during moderate intensity exercise in participants with long-chain fatty acid oxidation disorders and if it will raise blood ketones to levels similar to that reported among normal healthy subjects.

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Detailed Description

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Purpose: Subjects with long-chain fatty acid oxidation disorders (LC-FAOD) do not make ketones during fasting or with exercise. Ketones are an important alternative energy substrate during moderate exercise, sparing the oxidation of glucose and providing a source of ATP to the central nervous system and exercising muscle. Fatty acid oxidation in the liver is required to make ketones. Subjects with a LC-FAOD cannot generate ketones because of their block in fatty acid oxidation during exercise. Providing ketones in an oral ketone beverage may increase blood ketones with exercise to levels normally observed in humans.

Aim: To determine the safety and tolerability of an oral ketone beverage during moderate intensity exercise among subjects with a LC-FAOD compared to an isocaloric maltodextrin beverage, and to determine blood ketone concentrations.

Hypothesis: Oral consumption of a ketone beverage before moderate intensity exercise will be safe and well-tolerated, and will raise blood ketones among subjects with a LC-FAOD to concentrations similar to that reported in the literature among normal healthy subjects.

Conditions

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Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency Carnitine Palmitoyltransferase Deficiency 2 Very Long Chain Acyl Coa Dehydrogenase Deficiency Trifunctional Protein Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects with either CPT2, TFP, LCHAD or VLCAD deficiency will be randomized to receive a ketone beverage (see composition in Appendix A) or an isocaloric maltodextrin control beverage (see composition in Appendix A) before moderate intensity exercise. Twenty minutes after consuming the pre-exercise beverage, subjects will complete a moderate intensity treadmill exercise test for 45 minutes. After a washout period of 48 hours, subjects will repeat the exercise. During the 2nd exercise test subjects will crossover to the beverage not consumed during the 1st exercise study.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Sachets of the ketone or maltodextrin powder are coded and packaged identically. The bionutrition unit will prepare the beverage and maintain the randomization code and the code for the ketone and maltodextrin products.

Study Groups

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Nutrition Ketogenic Supplement

The Ketone pre-exercise beverage is a nutritional supplement. The supplement will be provided by Nestle as powered sachets to mix in water. It contains a mix of D-beta-hydroxybutyrate salts, flavors and stevia.

Group Type ACTIVE_COMPARATOR

Nutritional Ketone Supplement

Intervention Type DIETARY_SUPPLEMENT

Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener

Isocaloric Placebo Supplement

The maltodextrin pre-exercise beverage is a nutritional supplement. The supplement will be provided by Nestle as powered sachets to mix in water. It contains an isocaloric amount of maltodextrin, flavors and stevia similar to the ketone beverage.

Group Type SHAM_COMPARATOR

Isocaloric Placebo Supplement

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin with flavors and stevia sweetener

Interventions

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Nutritional Ketone Supplement

Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener

Intervention Type DIETARY_SUPPLEMENT

Isocaloric Placebo Supplement

Maltodextrin with flavors and stevia sweetener

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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NKS

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency
* speak English
* willing to complete 2 moderate intensity exercise treadmills

Exclusion Criteria

* subjects actively participating in another research study that prohibits their participation
* pregnant females
* subjects with diabetes or taking medications to treat diabetes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No