Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT04584346
• Date of registration: 10/10/2020
• Prospective Registration: Yes
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)
• Scientific title: Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson s Disease (PD) Symptoms and Biomarkers (MCT-PD)
• Date of first enrolment: January 21, 2021
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04584346
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

- 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 ( 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Dietary Supplement: Liquigen MCT oil

Primary Outcome(s)

Feasibiilty [Time Frame: 9 months]

Secondary Outcome(s)

Timed up & go (TUG) [Time Frame: Day 7 of enrollment]

Secondary ID(s)

20-N-0153

200153

Source(s) of Monetary Support

Please refer to primary and secondary sponsors