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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04829760
Eligibility Criteria:
Inclusion Criteria:
* Physician-diagnosed Parkinson's disease
* Age 40-85 years
* Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
* Hoehn \& Yahr stage \< 4 in the clinical "ON" state
* Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
* Complete informed consent in English
* Maintain habitual diet and exercise routine throughout study period
* Consume the study intervention twice per day during the eight-week intervention period
* Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks
* Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit
Exclusion Criteria:
* Atypical or secondary Parkinsonism
* Underweight (BMI \<18.5)
* Inability to swallow study supplement due to swallowing concerns
* Currently using a fiber supplement
* Use of another investigational product within 3 months of the screening visit
* Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT04829760
Study Brief:
Protocol Section:
NCT04829760