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Ketone Supplement
Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders
Phase < 1
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peak 40 minute exercise
Summary
This trial will test if a ketone drink is safe and tolerable for people with disorders that prevent the body from burning fats properly, and if it will raise blood ketone levels as much as is seen in healthy people.
Eligible Conditions
- Long-Chain 3-Hydroxyacyl-CoA Dehydrogenase Deficiency
- Trifunctional Protein Deficiency
- Acyl CoA Dehydrogenase Deficiency
- Carnitine Palmitoyltransferase Deficiency 2
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ peak 40 minute exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~peak 40 minute exercise
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abdominal discomfort
Adverse Events- causal relationship
Adverse Events- incidence
+7 moreSecondary study objectives
Blood Creatine Kinase
Blood Glucose
Blood Ketones
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Nutrition Ketogenic SupplementActive Control1 Intervention
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.
Group II: Isocaloric Placebo SupplementPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,304 Total Patients Enrolled