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Protocol Details

Acute effects of medium chain triglyceride (MCT) nutritional ketosis on Parkinson s Disease (PD) symptoms and biomarkers (MCT-PD)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-N-0153

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 50 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

MCT Medium Chain Triglyceride;
Ketogenic Diet;
Nutritional Ketosis;
Parkinson's Biomarkers

Recruitment Keyword(s)

None

Condition(s)

Parkinson's Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: Liquigen MCT oil

Supporting Site

National Institute of Neurological Disorders and Stroke

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 PD. Researchers want to learn more 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 will last for 4 weeks.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Must be able to speak English

2. Able and willing to provide informed consent

3. Male or female older than age 50 years

4. 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

5. BMI > 18.5, to minimize potential risk from expected mild weight loss from ketogenic diet

6. eGFR > 60 by MDRD equation (established on screening visit serum chemistry)

7. MOCA > 20, as well as having in the investigators' assessment the ability and willingness to adhere to either of the study diets

8. Agreement to adhere to Lifestyle Considerations throughout study duration

9. 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:

1. Atypical Parkinsonism or symptoms suggestive of a diagnosis other than PD by clinical criteria

2. Family history of early onset PD (<age 40) or known personal genetically causal etiology of PD (e.g. SNCA duplication, Parkin, PINK, DJ1) by previously obtained genetic testing

3. Currently pregnant

4. Sarcopenia defined as low BMI (<22 Bahat et al, 2019) with clinically defined weakness

5. Medical history of cardiac arrhythmia, heart failure, stroke / cerebral hemorrhage, epilepsy, other disease of the central nervous system, active cancer, end-stage liver disease, advanced kidney disease (CKD stage 3 or ESRD), beta thalassemia, or any other medical condition deemed by the PI to pose an increased risk for taking part in the study.

6. Inherited or other metabolic disease known to be worsened by ketogenic diet, e.g. inherited defect of lipid or amino acid metabolism

7. Diabetes on SGLT2 inhibitor or uncontrolled diabetes, defined as Hemoglobin A1c > 8.0% on screening test

8. History of kidney stones or gallbladder surgery

9. 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

10. Uncontrolled hypertension, defined as SBP > 180 mmHg or DBP > 105 mmHg on screening visit

11. Hyperlipidemia defined by LDL >/= 160 mg/dL as per ATP-III guidelines

12. Medical / psychiatric condition identified via clinical assessment in screening visit felt to impede completion of the study*

13. Presence of PD Psychosis or dementia, or other neuropsychiatric or psychiatric illness impeding consent and fidelity to the study intervention and/or measurements

14. Dietary or allergy restrictions as determined by research team to be prohibitive for the study

15. Inability to communicate and provide informed consent in English

16. 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.


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Citations:

Chaudhuri KR, Martinez-Martin P, Brown RG, Sethi K, Stocchi F, Odin P, Ondo W, Abe K, Macphee G, Macmahon D, Barone P, Rabey M, Forbes A, Breen K, Tluk S, Naidu Y, Olanow W, Williams AJ, Thomas S, Rye D, Tsuboi Y, Hand A, Schapira AH. The metric properties of a novel non-motor symptoms scale for Parkinson's disease: Results from an international pilot study. Mov Disord. 2007 Oct 15;22(13):1901-11. doi: 10.1002/mds.21596. PMID: 17674410.

Colla E. Linking the Endoplasmic Reticulum to Parkinson's Disease and Alpha-Synucleinopathy. Front Neurosci. 2019 May 29;13:560. doi: 10.3389/fnins.2019.00560. PMID: 31191239; PMCID: PMC6550095.

Chen MJ, Russo-Neustadt AA. Running exercise-induced up-regulation of hippocampal brain-derived neurotrophic factor is CREB-dependent. Hippocampus. 2009 Oct;19(10):962-72. doi: 10.1002/hipo.20579. PMID: 19294650; PMCID: PMC2756465.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Debra J. Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Irene H. Dustin, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10-CRC RM 5-1473
10 CENTER DR
BETHESDA MD 20814
(301) 402-4479
id30d@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04584346

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