How a low carb/ketogenic diet affects Parkinson's disease symptoms: a 36-week study
| ISRCTN | ISRCTN13221188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13221188 |
| Secondary identifying numbers | 01-2023-2024 |
- Submission date
- 27/02/2023
- Registration date
- 08/03/2023
- Last edited
- 16/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
New evidence suggests that a diet low in carbohydrates but high in healthy fats, called a low carbohydrate/healthy fat/ketogenic diet (LCHF/KD), could help treat symptoms of neurodegenerative diseases like Parkinson's Disease (PD). Common symptoms of PD include problems with thinking, poor sleep quality, and feeling tired all the time. However, there isn't enough information about how changing your diet can help these symptoms.
This research study wants to find out if changing your diet can help people with PD. They will test three different diets over 8 weeks: a normal American diet, an American diet with MCT oil, and a low carbohydrate/healthy fat/ketogenic diet with MCT oil.
MCT stands for medium-chain triglycerides, which are a type of fat found in coconut oil, palm kernel oil, and dairy products. MCT oil is a supplement made by extracting and isolating these medium-chain triglycerides from these sources. It is a popular supplement among people following a low carbohydrate or ketogenic diet, as it is quickly absorbed and converted into ketones, which can provide energy to the body and brain.
The researchers will compare the effects of each diet on how well people can think, how healthy their body is, how well they sleep, and how tired they feel. This study will use a randomized crossover trial design, meaning that each person will try each of the three diets at different times, and the researchers will compare the results.
Who can participate?
Adult patients aged 18 - 35 years with PD.
What does the study involve?
The research will involve a comparison of 8 weeks of a standard American diet (SAD), 8 weeks of a Standard American Diet (SAD-MCT) plus daily MCT oil, and an 8-week ketogenic diet plus daily MCT oil (LCHF/KD-MCT)intervention with a pretest/posttest study design using common blood tests for metabolic biomarkers, and scales for cognition, sleep, and fatigue widely used in assessing symptoms in patients with PD. Baseline and post-intervention testing will investigate the effectiveness of each intervention by repeating the same biomarker blood tests, cognition, sleep, and fatigue scales and comparing post-study results with the baseline results in adults 30-85 with PD Hoehn and Yahr Stages I-IV. The research will involve a 4-week washout period between dietary interventions.
The study protocol will also require daily blood glucose and ketone testing using a home Glucose/Ketone meter provided at no cost to participants for all interventions, (SAD, SAD + MCT OIl, and LCHF/KD) dietary interventions. The 8 week SAD will be the typical diet based on the 2020 USDA Dietary Guidelines for all Americans. Adherence to the LCHF/KD-MCT nutrition plan will be based on Dr. Eric Westman's (Duke University) Page 4 Food list, For all dietary interventions, data using daily food logs, cognition, sleep quality, and fatigue surveys, with baseline metabolic biomarkers (free of charge) of HgA1C, Triglycerides, HDL, Fasting Insulin, C-Reactive Protein, weight, and waist circumference will be collected.
What are the possible benefits and risks of participating?
Benefits to society include: Research on nutritional interventions has shown positive effects on persons with neurodegenerative diseases like Parkinson’s Disease (PD).
Minimal risk, but the possibility of psychological stress exists. The expected risks from participating in this study are minimal, which means they are equal to the risks the participants would encounter in everyday life. The risks involved in this study include minimal stress from daily finger pricks for glucose/ketone testing, which is customary for patients who need to test blood sugar/ketones daily due to diabetes. To reduce this risk of stress, the study team will supply a trained assistant and/or training videos to educate participants on the proper ways to test blood using the provided KetoMojo Blood Glucose/Ketone meter until they feel comfortable using the meter to test blood
each morning. In addition, participants will have access to training videos on the KetoMojo website, free of charge, that show them exactly how to use the meter to test blood glucose and ketones each morning. In addition, Dr. Tidman is available by email, Live Zoom meeting, or by phone to respond to any questions or concerns participants might have during the course of the study.
Where is the study run from?
Colorado Parkinson Foundation (USA)
When is the study starting and how long is it expected to run for?
January 2023 to December 2025
Who is funding the study?
Colorado Parkinson Foundation (USA)
Who is the main contact?
Dr Melanie Tidman, melanietidman@gmail.com
Contact information
Principal Investigator
521 Vineyard Rd NE
Albuquerque
87113
United States of America
 ORCID ID |
0000-0002-6333-8514 |
|---|---|
| Phone | +1 5052593118 |
| mtidman@liberty.edu |
Study information
| Study design | Interventional randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Community, Home, Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Effects of three dietary approaches on biomarkers, cognition, sleep and fatigue in Parkinson’s disease: a 36-week crossover pilot study |
| Study hypothesis | This 8-week randomized crossover pilot study will investigate whether an LCHF/KD-MCT approach is a safe and feasible adjunctive treatment approach for improved health biomarkers, cognition, sleep quality, and fatigue with improved scores on commonly used surveys/scales as compared with the SAD and SAD + MCT Oil approaches, and whether an LCHF/KD can be a complementary treatment approach in PD |
| Ethics approval(s) | Approved 16/02/2023, Liberty University IRB (Green Hall 2845, 1971 University Blvd., Lynchburg, VA 24515, USA; +1 434-582-2000; no email provided), ref: IRB-FY22-23-440 |
| Condition | Nutritional interventions for Parkinson's Disease |
| Intervention | The research will involve a comparison of: Intervention 1: 8 weeks of consuming a Standard American Diet as defined by the USDA Food Pyramid Intervention 2: 8 weeks of consuming a Standard American Diet (USDA Food Pyramid) + MCT Oil. Intervention 3: 8 weeks of consuming a Low Carbohydrate Healthy Fat/Ketogenic Diet (70% Fats, 25% proteins, 5% carbohydrates) for a total of 36 weeks. Three groups will each progress through each of the 3 interventions for periods of 8 weeks, with a 4-week washout period between each interventional strategy. Randomization will be done using a Simple Randomization method (Dice Throw method with dice containing numbers 1, 2 or 3) Baseline and post-intervention testing will investigate the effectiveness of each intervention by repeating the same biomarker blood tests, cognition, sleep, and fatigue scales and comparing post-study results with the baseline results in adults 30-85 with PD Hoehn and Yahr Stages I-IV. The research will involve a 4-week washout period between dietary interventions. The study protocol will also require daily blood glucose and ketone testing using a home Glucose/Ketone meter provided at no cost to participants for all interventions, (SAD, SAD + MCT OIl, and LCHF/KD) dietary interventions. The 8 week SAD will be the typical diet based on the 2020 USDA Dietary Guidelines for all Americans. Adherence to the LCHF/KD-MCT nutrition plan will be based on Dr. Eric Westman's (Duke University) Page 4 Food list, For all dietary interventions, data using daily food logs, cognition, sleep quality, and fatigue surveys, with baseline metabolic biomarkers (free of charge) of HgA1C, Triglycerides, HDL, Fasting Insulin, C-Reactive Protein, weight, and waist circumference will be collected. |
| Intervention type | Mixed |
| Primary outcome measure | Measured before and after each 8-week diet period: 1. Blood biomarkers measured using blood test: 1.1. Biomarkers HDL 1.2. HgA1C 1.3. Triglycerides 1.4. Fasting Insulin 1.5. hs-C-Reactive Protein 2. Biometrics 2.1. BMI (kg/m²) 2.2. Waist circumference (cm) 3. Parkinson's symptoms 3.1. Cognition using scores on the Parkinson’s Disease Cognitive Rating Scale 3.2. Sleep quality as measured by the Epworth Sleepiness Scale and the Parkinson’s Disease Sleep Scale 3.3. Fatigue scores measured by the Parkinson’s Disease Fatigue Scale 3.4. Scores on Part I of the United Parkinson’s Disease Rating Scale (UPDRS) 3.5.Scores on Part II of the United Parkisnon’s Disease Rating Scale (UPDRS) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/01/2023 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 36 |
| Participant inclusion criteria | 1. Between the ages of 30-85 years 2. Live in the United States 3. Can speak, read and understand English 4. Diagnosis of PD (H-Y Stages I-IV) 5. BMI>18.5 kg/m² 6. Ability to understand and follow an LCHF/KD diet 7. Obtained permission to participate from their Primary Care Provider (PCP) or neurologist 8. Signed the informed consent and the HIPAA Release of Medical Information form |
| Participant exclusion criteria | 1. Does not meet inclusion criteria 2. Persons with PD H-Y Stage V 3. Persons with unstable/uncontrolled type 2 diabetes |
| Recruitment start date | 04/01/2023 |
| Recruitment end date | 12/01/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Colorado Springs
80920
United States of America
Sponsor information
Research organisation
1155 Kelly Johnson Blvd, Suite 111
Colorado Springs
80920
United States of America
| Phone | +1(719) 884-0103 |
|---|---|
| db_mgr@co-parkinson.org | |
| Website | https://co-parkinson.org/ |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Plan to publish in a peer-reviewed research journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and may be made available at a later date |
Editorial Notes
16/12/2024: The following changes were made to the trial record:
1. The public title was changed from "How a low carb/ketogenic diet affects Parkinson's disease symptoms: a 12-week study" to "How a low carb/ketogenic diet affects Parkinson's disease symptoms: a 36-week study".
2. The overall end date was changed from 05/01/2024 to 31/12/2025.
04/05/2023: The scientific title was changed from 'The effects of a ketogenic diet on biomarkers, cognition, fatigue, symptoms and sleep in Parkinson's disease: a 12-week randomized crossover pilot study' to 'Effects of three dietary approaches on biomarkers, cognition, sleep and fatigue in Parkinson’s disease: a 36-week crossover pilot study'.
02/03/2023: Trial's existence confirmed by Liberty University IRB.
