An Early Phase 1 interventional study of Nutritional Ketone Supplement and Isocaloric Placebo Supplement in Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency, Carnitine Palmitoyltransferase Deficiency 2 and Very Long Chain Acyl Coa Dehydrogenase Deficiency, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Oregon Health and Science University · Early Phase 1, Interventional, and Other
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.
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.
26 studies on the registry are indexed under Protein Deficiency; 4 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 20 interventional studies indexed under Protein Deficiency.
Browse Protein Deficiency studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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Exclusion Criteria:
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.
Dietary Supplement: Nutritional Ketone 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.
Dietary Supplement: Isocaloric Placebo Supplement
Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener
Also known as: NKS
Maltodextrin with flavors and stevia sweetener
Adverse Events- incidence
Number of Adverse events
Time frame: 2 hours after product intake
Adverse Events- type
Description of Adverse events: categorical
Time frame: 2 hours after product intake
Adverse Events- severity
Severity of adverse event: grade 1-5
Time frame: 2 hours after product intake
Adverse Events- causal relationship
Yes/No related to product intake
Time frame: 2 hours after product intake
Abdominal discomfort
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Decreased appetite
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Gastric reflux
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Nausea
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Diarrhea
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Headache
visual analogue scale (VAS) 0-10
Time frame: 2 hours after product intake
Blood Ketones
plasma beta-hydroxybutyrate concentration
Time frame: 20 minutes after moderate intensity exercise
Blood Creatine Kinase
plasma CK concentration
Time frame: 20 minutes after moderate intensity exercise
Blood Glucose
serum glucose
Time frame: 20 minutes after moderate intensity exercise
Blood Lactate
serum lactate concentration
Time frame: 20 minutes after moderate intensity exercise
Blood Pressure
diastolic BP
Time frame: peak 40 minute exercise
Blood Pressure
systolic BP
Time frame: peak 40 minute exercise
Perceived exertion
Borg scale 1-20
Time frame: peak 40 minute exercise
Respiratory Exchange Ratio
VCO2/VO2 0.7 - 1.0
Time frame: peak 40 minute exercise
Heart Rate
beats per minute
Time frame: peak 40 minute exercise
Plan to share: Yes — Participants will be provided with creatine kinase lab test and body composition measurement. The results of their creatine kinase lab test will be placed in their medical record. Results of the study will be written in a published manuscript and summarized in a cover letter to be sent via mail or email to the participant after publication of the data.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University