Nutrition Ketogenic Supplement for Protein Deficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oregon Health & Science University, Portland, OR
Protein Deficiency+4 More
Nutritional Ketone Supplement - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Protein Deficiency

Study Objectives

10 Primary · 8 Secondary · Reporting Duration: peak 40 minute exercise

Hour 2
Abdominal discomfort
Adverse Events- causal relationship
Adverse Events- incidence
Adverse Events- severity
Adverse Events- type
Decreased appetite
Diarrhea
Gastric reflux
Headache
Nausea
20 minutes after moderate intensity exercise
Blood Creatine Kinase
Blood Glucose
Blood Ketones
Blood Lactate
peak 40 minute exercise
Blood Pressure
Heart Rate
Perceived exertion
Respiratory Exchange Ratio

Trial Safety

Safety Progress

1 of 3

Other trials for Protein Deficiency

Trial Design

2 Treatment Groups

Nutrition Ketogenic Supplement
1 of 2
Isocaloric Placebo Supplement
1 of 2
Active Control
Non-Treatment Group

5 Total Participants · 2 Treatment Groups

Primary Treatment: Nutrition Ketogenic Supplement · Has Placebo Group · Phase < 1

Isocaloric Placebo Supplement
DietarySupplement
ShamComparator Group · 1 Intervention: Isocaloric Placebo Supplement · Intervention Types: DietarySupplement
Nutrition Ketogenic Supplement
DietarySupplement
ActiveComparator Group · 1 Intervention: Nutritional Ketone Supplement · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: peak 40 minute exercise

Trial Background

Prof. Melanie B Gillingham, Associate Professor
Principal Investigator
Oregon Health and Science University
Closest Location: Oregon Health & Science University · Portland, OR
Photo of Portland  1Photo of Portland  2Photo of Portland  3
2013First Recorded Clinical Trial
3 TrialsResearching Protein Deficiency
565 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.