Dietitian-Guided Nutritional Inter… for Parkinson's (NCT07213856)
Reduce constipation using dietitian guidance
- Trial ID
- NCT07213856
- Official Title
- Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial
- Goal
- Reduce constipation using dietitian guidance
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Study Type
- INTERVENTIONAL
- Enrollment
- 54 participants
- Conditions
- Parkinsons Disease (PD), Constipation - Functional
- Interventions
- Dietitian-Guided Nutritional Intervention
Summary For Families
Researchers want to know whether a dietitian-guided eating plan can increase weekly bowel movements and ease constipation in people with Parkinson's, and whether it changes gut bacteria, what people eat, and overall nutritional status. Participants follow a personalized diet from a dietitian and have follow-up sessions for three months, while a control group receives general dietary advice after the study; bowel habits, gut bacteria, diet quality, and nutrition are measured at the start, midpoint, and end. Adults with Parkinson's who have functional constipation and have been on a stable levodopa dose for at least three months are eligible, while people with atypical parkinsonism, more advanced disease, dementia or severe medical conditions, recent antibiotic or probiotic use, recent continuous laxative or opioid use, severe swallowing problems, recent nutritional care, or certain gastrointestinal or major illnesses are excluded.
Locations
- Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dietitian-Guided Nutritional Intervention. Researchers want to know whether a dietitian-guided eating plan can increase weekly bowel movements and ease constipation in people with Parkinson's, and whether it changes gut bacteria, what people eat, and overall nutritional status. Participants follow a personalized diet from a dietitian and have follow-up sessions for three months, while a control group receives general dietary advice after the study; bowel habits, gut bacteria, diet quality, and nutrition are measured at the start, midpoint, and end. Adults with Parkinson's who have functional constipation and have been on a stable levodopa dose for at least three months are eligible, while people with atypical parkinsonism, more advanced disease, dementia or severe medical conditions, recent antibiotic or probiotic use, recent continuous laxative or opioid use, severe swallowing problems, recent nutritional care, or certain gastrointestinal or major illnesses are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Participants will have follow-up sessions with the dietitian for 3 months and complete assessments at baseline, midpoint, and end of the intervention.