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

NCT05411835 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-01-31
Completion
2024-01-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05411835 on ClinicalTrials.gov