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
- Registry Record Last Updated
- 2026-06-16 (1 month ago)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Levodopa: Must be taking levodopa (criteria text: "inclusion criteria: * adults with a previous diagnosis of parkinson's disease * on a stable dose of levodopa for at least 3 months * diagnosis of functional ...")
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "inclusion criteria: * adults with a previous diagnosis of parkinson's disease * on a stable dose of levodopa for at least 3 months * diagnosis of functional ...")
- Time since diagnosis: Diagnosed at least 0.3 years ago (criteria text: "inclusion criteria: * adults with a previous diagnosis of parkinson's disease * on a stable dose of levodopa for at least 3 months * diagnosis of functional ...")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis at least 0.3 years ago.
Locations
- Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07213856. It is the one about "Reduce constipation using dietitian guidance". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Assessments are done at baseline, midpoint, and end of the intervention over 3 months. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Whether you are placed in the no-treatment group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in it would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- 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. Whether you are placed in the no-treatment group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in it would be.
- How many visits does this trial involve?
- Assessments are done at baseline, midpoint, and end of the intervention over 3 months.