CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Liquigen MCT oil +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04584346
NCT04584346Phase 1Completed

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

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Oct 14, 2020·Updated Sep 13, 2022

In Brief

A Phase 1 clinical trial evaluating Liquigen MCT oil and Standard American Diet for Parkinson's Disease. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartJan 21, 2021
Primary CompletionOct 13, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.7 years ago

Interventions

Liquigen MCT oildietary

MCT oil is a nutritional supplement. The Ketogenic diet restricted carbohydrates to reach 80/5-10/10-15 (lipid:carb:protein daily energy) values

Standard American Dietother

Standard diet with macronutrient composition lipid 35%, protein 10-15%, carbohydrate 50-55%