Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT04477161
Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed Parkinson's Disease
* 40-75 years of age
* On stable dopaminergic therapy
* Willing and able to complete the informed consent form in English
* Willing to consume the study supplement four times each day during the 4-week intervention period
* Willing to complete all dietary recalls over approximately 6 weeks
* Willing to complete all daily and weekly questionnaires throughout the six weeks.
Exclusion Criteria:
* Does not meet the above criteria
* Atypical or secondary Parkinsonism
* BMI \>30
* Rheumatological or other inflammatory conditions
* Following of the ketogenic diet
* History of ulcer disease
* History of irritable bowel disorder or irritable bowel syndrome
* Currently taking any medication that could affect stool formation.
* Diagnosis of Diabetes mellitus Type 1 or Type 2
* Currently smoking (including vaping) tobacco products.
* Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
* Note: a pregnancy test will be administered prior to initiating consumption of the study supplement. Women who are pregnant will be withdrawn from the study at that time.
* Use of another investigational product within 3 months of the initial visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04477161
Study Brief:
Protocol Section:
NCT04477161