Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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13 May 2024 |
Main ID: |
NCT05469997 |
Date of registration:
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15/06/2022 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome
KIM |
Scientific title:
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Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome |
Date of first enrolment:
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March 1, 2023 |
Target sample size:
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50 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT05469997 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Silke Appel-Cresswell, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 40-85 years
- PD diagnosis based on Movement Disorder Society (MDS) criteria [52]
- Hoehn & Yahr score of 1 to 3
- On stable dopaminergic medication for at least one month
Exclusion Criteria:
- Atypical parkinsonism
- Medical or psychiatric conditions that would prevent full participation in the
nutrition intervention
- Significant dysphagia
- Diabetes on insulin
- Anti-coagulation on warfarin
- Inflammatory bowel disease
- Dementia defined by Montreal Cognitive Assessment (MoCA) Scores of less than 21
- Inability to fill in electronic questionnaires or understand study instructions
- Use of immunomodulatory agents
- Probiotic use in the last 4 weeks (except for dietary sources such as yoghurt, kefir
etc.), or antibiotic use in the last 3 months prior to the trial
- Use of MCT oil or on ketogenic diet in last 8 weeks prior to the trial
- Allergic to MCT oil, coconut oil, or coconut
Age minimum:
45 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Behavioral: Mediterranean-Ketogenic Diet
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Dietary Supplement: Mediterranean diet supplemented with medium-chain triglyceride oil
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Primary Outcome(s)
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Change from baseline and difference across interventions in measures of fecal and serum calprotectin, a biomarker for gut inflammation.
[Time Frame: Preintervention 1 (Baseline 1)/ Post-intervention 1 (Week 8)/ Pre-intervention 2 (baseline 2; Week 16)/ Post-intervention 2 (Week 24)]
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Changes from baseline and differences across interventions in other measures of gut health, namely short-chain fatty acid production, gut-barrier integrity, and microbial composition.
[Time Frame: Preintervention 1 (Baseline 1)/ Post-intervention 1 (Week 8)/ Pre-intervention 2 (baseline 2; Week 16)/ Post-intervention 2 (Week 24)]
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Secondary Outcome(s)
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The number of participants who completed the study after successful enrollment relative to the total enrolled participants.
[Time Frame: Post-intervention 1 (Week 8)/Post-intervention 2 (Week 24)]
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Percent time spent in clinically relevant levels of ketosis ( equivalent to >0.5 mmol/L) by each participant throughout each intervention.
[Time Frame: Post-intervention 1 (Week 8)/Post-intervention 2 (Week 24)]
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Secondary ID(s)
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H21-03747
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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