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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05411835
Other study ID # 23859
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date August 1, 2022
Est. completion date January 22, 2024

Study information

Verified date October 2022
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date January 22, 2024
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events- incidence Number of Adverse events 2 hours after product intake
Primary Adverse Events- type Description of Adverse events: categorical 2 hours after product intake
Primary Adverse Events- severity Severity of adverse event: grade 1-5 2 hours after product intake
Primary Adverse Events- causal relationship Yes/No related to product intake 2 hours after product intake
Primary Abdominal discomfort visual analogue scale (VAS) 0-10 2 hours after product intake
Primary Decreased appetite visual analogue scale (VAS) 0-10 2 hours after product intake
Primary Gastric reflux visual analogue scale (VAS) 0-10 2 hours after product intake
Primary Nausea visual analogue scale (VAS) 0-10 2 hours after product intake
Primary Diarrhea visual analogue scale (VAS) 0-10 2 hours after product intake
Primary Headache visual analogue scale (VAS) 0-10 2 hours after product intake
Secondary Blood Ketones plasma beta-hydroxybutyrate concentration 20 minutes after moderate intensity exercise
Secondary Blood Creatine Kinase plasma CK concentration 20 minutes after moderate intensity exercise
Secondary Blood Glucose serum glucose 20 minutes after moderate intensity exercise
Secondary Blood Lactate serum lactate concentration 20 minutes after moderate intensity exercise
Secondary Blood Pressure diastolic BP peak 40 minute exercise
Secondary Blood Pressure systolic BP peak 40 minute exercise
Secondary Perceived exertion Borg scale 1-20 peak 40 minute exercise
Secondary Respiratory Exchange Ratio VCO2/VO2 0.7 - 1.0 peak 40 minute exercise
Secondary Heart Rate beats per minute peak 40 minute exercise
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