NCT05411835

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Ketone Supplement	Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener
DIETARY_SUPPLEMENT	Isocaloric Placebo Supplement	Maltodextrin with flavors and stevia sweetener

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-31
• Completion: 2024-01-22
• First posted: 2022-06-09
• Last updated: 2024-04-02

Locations

1 site across 1 country: United States