Phase 1
N=16
Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT04584346 ↗Enrolled (actual)
16
Serious AEs
3.2%
Results posted
Aug 2022
Primary outcome: Primary: Feasibiilty of Ketogenic Diet - Retention (Co-primary Endpoint) — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Liquigen MCT oil (Dietary_supplement); Standard American Diet (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibiilty of Ketogenic Diet - Retention (Co-primary Endpoint) |
15 | — |
| PRIMARY Feasibility of Ketogenic Diet - Adherence (Co-primary Endpoint) |
9.7 | — |
| PRIMARY Feasibility of Ketogenic Diet - Acceptability (Co-primary Endpoint) |
2.26 | — |
| SECONDARY Timed Up and Go (TUG) |
8.4; 9.1 | — |
Summary
Background:
The ketogenic diet uses fats as a person's major energy source rather than carbohydrates. There is increasing interest in using this diet to treat neurodegenerative disorders like Parkinson's disease. Researchers want to learn more about the ketogenic diet before recommending this diet in clinical practice.
Objective:
To study the effects of a ketogenic diet for someone with PD.
Eligibility:
People over age 50 with mild to moderate PD.
Design:
Participants will be screened with surveys and a 10-foot walking test. They will have a medical history, physical exam, and blood test.
Participants will be contacted twice in a 1-week period to discuss what they ate over the last 24 hours. They will log data about their daily exercise and activities using an online fitness tracking app.
Participants will stay at NIH Clinical Center for 1 week. They will be put into 1 of 2 groups. One group will follow a ketogenic diet and take MCT oil. The other group will follow a low-fat diet. Their body measurements will be taken. They will meet with a physical therapist and nutritionist.
Participants will have daily respiratory and glucose monitoring. They will have cognitive tests and complete surveys. They will have walking, motor function, and reaction time/finger tapping tests. They will have heart and nerve function tests. They will have electrocardiograms and electroencephalograms. Blood will be taken twice daily.
Participants will follow the ketogenic diet at home for 2 weeks. They will log their activities using the fitness tracking app. Then they will have a follow-up visit at NIH.
Participation in the trial will last for 4 weeks.
Eligibility Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Must be able to speak English
- Able and willing to provide informed consent
- Male or female older than age 50 years
- Clinically probable diagnosis of Parkinson s Disease by UK Brain Bank Criteria, of moderate severity, with ability to safely walk independently for at least a short distance (20 feet) as determined on screening visit
- BMI > 18.5, to minimize potential risk from expected mild weight loss from ketogenic diet
- eGFR > 60 by MDRD equation (established on screening visit serum chemistry)
- MOCA > 20, as well as having in the investigators' assessment the ability and willingness to adhere to either of the study diets
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Adhering to Usual Diet (SAD) at baseline, as per investigator determination
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- Atypical Parkinsonism or symptoms suggestive of a diagnosis other than PD by clinical criteria
- Family history of early onset PD ( 8.0% on screening test
- History of kidney stones or gallbladder surgery
- Biliary / liver disease, defined on screening labs, by presence of any of the following: Total bilirubin (TB) > 2x ULN or > 2 mg/dL; AST >3x ULN; or ALT >5x ULN
- Uncontrolled hypertension, defined as SBP > 180 mmHg or DBP > 105 mmHg on screening visit
- Hyperlipidemia defined by LDL >/= 160 mg/dL as per ATP-III guidelines
- Medical / psychiatric condition identified via clinical assessment in screening visit felt to impede completion of the study*
- Presence of PD Psychosis or dementia, or other neuropsychiatric or psychiatric illness impeding consent and fidelity to the study intervention and/or measurements
- Dietary or allergy restrictions as determined by research team to be prohibitive for the study
- Inability to communicate and provide informed consent in English
- No history of previous use of ketogenic or similar diet to a degree that could interfere with study blinding
- A thorough medical and social history will be performed during the screening visit including questions regarding alcohol and substance abuse. If active alcohol abuse or other current substance abuse is identified which could increase the risk of study participation, then participants will be excluded.
Data sourced from ClinicalTrials.gov (NCT04584346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.