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

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status and phase

Completed
Early Phase 1

Conditions

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

Treatments

Dietary Supplement: Nutritional Ketone Supplement
Dietary Supplement: Isocaloric Placebo Supplement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

5 participants in 2 patient groups

Nutrition Ketogenic Supplement
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Nutritional Ketone Supplement
Isocaloric Placebo Supplement
Sham Comparator group
Description:
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.
Treatment:
Dietary Supplement: Isocaloric Placebo Supplement

Trial contacts and locations

1

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Central trial contact

Melanie B Gillingham, PhD; Ashley Gregor, MS

Data sourced from clinicaltrials.gov

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