Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency Clinical Trial
Official title:
Safety and Tolerability of Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders
Verified date | October 2022 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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