Active not recruitingNAINTERVENTIONAL

Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's Disease

This study is investigating a new drink designed for people living with Parkinson's disease, especially those who experience constipation. Constipation is a common issue for many with Parkinson's. The drink contains a type of fibre called inulin, which is found in many vegetables, along with B-vitamins and vitamin D. Researchers believe these ingredients could be beneficial. Over 12 weeks, the study will check if this special drink can help improve gut health, how well people are nourished, and their general quality of life. Half of the participants will receive the special drink, and the other half will receive a 'dummy' drink (placebo) to compare the effects. This is a small initial study to see if the drink is worth further investigation.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Ulster

Enrolment target

Start

14 Nov 2024

Estimated completion

01 Nov 2026

Constipation Parkinson Disease

What is this study about?

If you live with Parkinson's disease, you might know that constipation can be a tricky and common problem, affecting up to 8 out of 10 people. This often comes under what doctors call 'non-motor symptoms' – meaning it's not directly about movement, but it can still affect your daily life.

Researchers are looking into whether what we eat and drink can make a real difference for these non-motor symptoms. We already know that eating more fibre can help with constipation. This study is focusing on a specific type of fibre called inulin, which is found naturally in many vegetables like chicory. Earlier research has suggested that inulin might help with constipation in people with Parkinson's.

Working with a food company, a special drink has been created. It’s enriched with chicory inulin, plus extra B-vitamins and vitamin D, as these vitamins are thought to be helpful in Parkinson's disease. This study is a 12-week 'feasibility study', which means it's a first step to see if this new drink works well and if it's practical for people to use. The main goal is to check how this drink affects gut health (like constipation), your nutritional levels, and your overall quality of life.

Key takeaways

It's a study looking at a new drink for people with Parkinson's and constipation.
The drink contains helpful fibre (inulin) and vitamins B and D.
The study aims to see if it improves gut health and quality of life.
It's a 12-week study, and some participants will receive a 'dummy' drink.
It’s a 'feasibility study' – an early step to see if it works.

Who may be eligible?

To be part of this study, you need to have a diagnosis of Parkinson's disease and be 18 years old or older. You also need to be able to understand the study and agree to take part yourself.

There are some reasons why you might not be able to join. For example, if you live in a care home or hospital, or if your Parkinson's symptoms are caused by something else like a medication or infection. If you have diabetes, or if you regularly get B12 injections, you won't be able to participate. Also, if you're currently taking antibiotics or using supplements that already contain B-vitamins, inulin, or probiotics, this study might not be suitable for you.

Finally, if you have any allergies to the ingredients in the study drinks, regularly eat fermented foods or probiotic yoghurts every day, or are already taking part in another medical study, you wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a diagnosis of Parkinson's disease?
Are you 18 years old or older?
Do you understand what taking part would involve and can you give your consent?
Do you NOT have diabetes?
Are you NOT currently taking antibiotics or certain supplements (B-vitamins, inulin, probiotics)?
Do you NOT have any allergies to the ingredients in common drinks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to drink a specific drink every day for 12 weeks. You would be randomly assigned to receive either the special functional drink or a 'dummy' drink (placebo) that looks and tastes similar but doesn't contain the active ingredients. You wouldn't know which drink you are receiving. The study involves regular check-ups and assessments, which might include questionnaires about your digestion, diet, and how you feel generally. You might also be asked to provide some samples, like blood tests, to check your nutritional status and gut health. The total duration of your active involvement in the study would be 12 weeks for drinking the supplement, plus any initial screening and final follow-up appointments.

Potential risks and benefits

Potential benefits of taking part could include an improvement in your constipation, better nutrient levels, and possibly a boost in your overall quality of life, although this is not guaranteed as it is a research study. As with any study, there are potential risks, which might include minor side effects from the drink, or the inconvenience of attending appointments and providing samples. However, all ingredients in the drinks are commonly found in food. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Human Intervention Studies Unit, Ulster University
Verified postcode
Coleraine, United Kingdom

Common questions

What is 'functional food'?

Functional food is a food or drink that has extra health benefits beyond its basic nutrition, like this drink designed to help with specific issues in Parkinson's.

What is inulin?

Inulin is a type of natural fibre, found in many plants, that can help your digestion and gut health.

Will I know if I'm getting the special drink or the dummy drink?

No, you won't know which drink you're taking. This helps ensure the study results are fair and unbiased.

How long does the study last?

Your active participation in the study, involving drinking the supplement, will last for 12 weeks.

Can I still take my regular Parkinson's medicines?

Yes, you would continue to take all your usual medications as prescribed by your doctor. This study is about a drink, not a medication.