ConstipationFood4PDNCT06697626
Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's Disease
A study testing Inulin, B-vitamins and vitamin D in people with Constipation and Parkinson Disease, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Parkinson Disease
- What is being tested?
- Inulin, B-vitamins and vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson Disease (PD)
- Aged ≥18 years
- Individuals with the capacity to provide informed consent
Who cannot join
- Individuals with PD living in institutional care or in hospital
- Drug, infection or toxin induced parkinsonism
- Individuals with diabetes
- B12 injection users
- Currently taking antibiotics
- Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics)
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- Any other medical, cognitive or psychosocial issue, or co-enrolment in another study, that could interfere or disrupt adherence to the study requirements
- An allergy to any of the ingredients in the functional and/or control drinks
- Consuming a fermented food and/or probiotic yogurts on a daily basis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, County Londonderry, BT52 1SA
About this study
Official title: Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's
Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.
- Conditions
- Constipation, Parkinson Disease
- Being tested
- Inulin, B-vitamins and vitamin D, Placebo group
- Keywords
- Constipation, Fibre, B-vitamins, Functional food, Nutritional status, Parkinson disease
- Medical subject headings
- Constipation, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin, B-vitamins and vitamin DDietary supplement
Intervention twice daily with:
10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D
Placebo groupDietary supplement
A twice daily placebo drink with similar energy content but without the additional nutrient provision
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement (Functional drink) | Active comparator | An enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg).
This drink will be consumed twice daily for an intervention period of 12 weeks Receives: Dietary Supplement: Inulin, B-vitamins and vitamin D |
| Placebo drink | Placebo comparator | A placebo drink drink with similar energy content but without the additional nutrient provision.
This drink will be consumed twice daily an intervention period of 12 weeks. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary fibre intake
A food frequency questionnaire and 4-day food diary will be completed and analysed using nutritional analysis software to determine intake of dietary fibre (g/day) pre- and post- intervention.
Measured: 12 weeks
Gut microbiome profile
Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
Measured: 12 weeks
Quality of life assessment
Assessed using The Parkinson's Disease Questionnaire (PDQ-39). This 39-item questionnaire assesses how often participants with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Answers are based on a 5-point ordinal scoring system ranging from 0 to 4, with lower scores reflecting a better quality of life.
Measured: 12 weeks
Parkinsons Disease symptoms
Assessed using the MDS-Unified Parkinson Disease Rating Scale (MDS-UDPRS). The MDS-UPDRS has four parts: I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Higher scores indicate more severe impairment.
Measured: 12 weeks
Gastrointestinal symptoms
Assessed using the Gastrointestinal Symptom Rating Scale. This 15-item questionnaire uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative option. Higher scores indicate more severe symptoms.
Measured: 12 weeks
Constipation
Assessed using the Bristol Stool Chart, a diagnostic tool that participants can use to classify their stools based on their appearance. The chart ranges from type 1 (hard) to type 7 (loose, watery) and may identify problems with bowel movements through the shape and consistency of the stool.
Measured: 12 weeks
Secondary outcomes (7)
Vitamin B12
Serum total vitamin B12 measured by microbiological assay based on a colistin sulphate-resistant strain of Lactobacillus leichmannii; serum methylmalonic acid measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Measured: 12 weeks
Folate
Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.
Measured: 12 weeks
Vitamin B6
Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.
Measured: 12 weeks
Riboflavin
Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac
Measured: 12 weeks
Serum total homocysteine
Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Measured: 12 weeks
Vitamin D
Vitamin D as measured by serum 25-hydroxyvitamin D status, using liquid chromatography mass spectrometry.
Measured: 12 weeks
Inflammation
Markers of inflammation (analysed by enzyme-linked immunosorbent assay): C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), tumour necrosis factor (TNF-α).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start14 Nov 2024
- Primary completion17 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twice daily intervention for 12 weeks with one of the following treatments (in powder form): 1. An enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg). 2. A control/placebo drink with similar energy content but without the additional nutrient provision.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Auckland, New Zealand, Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697626
- Sponsor's protocol ID
- REC/24/0034
- Acronym
- Food4PD
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's
- ClinicalTrials.gov ID
- NCT06697626
- Acronym / sponsor ID
- Food4PD / REC/24/0034
- Conditions
- Constipation, Parkinson Disease
- Keywords
- Constipation, Fibre, B-vitamins, Functional food, Nutritional status, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Leeds, University of Auckland, New Zealand, Biotechnology and Biological Sciences Research Council
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Twice daily intervention for 12 weeks with one of the following treatments (in powder form): 1. An enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg). 2. A control/placebo drink with similar energy content but without the additional nutrient provision.
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement (Functional drink) | Active comparator | Dietary Supplement: Inulin, B-vitamins and vitamin DAn enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg). This drink will be consumed twice daily for an intervention period of 12 weeks |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo groupA placebo drink drink with similar energy content but without the additional nutrient provision. This drink will be consumed twice daily an intervention period of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson Disease (PD)
- Aged ≥18 years
- Individuals with the capacity to provide informed consent
Key exclusion criteria (9 listed)
- Individuals with PD living in institutional care or in hospital
- Drug, infection or toxin induced parkinsonism
- Individuals with diabetes
- B12 injection users
- Currently taking antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin, B-vitamins and vitamin DIntervention twice daily with: 10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D | Dietary supplement | Dietary Supplement (Functional drink) |
| Placebo groupA twice daily placebo drink with similar energy content but without the additional nutrient provision | Dietary supplement | Placebo drink |
Primary outcome
Dietary fibre intake
Time frame: 12 weeks
A food frequency questionnaire and 4-day food diary will be completed and analysed using nutritional analysis software to determine intake of dietary fibre (g/day) pre- and post- intervention.
Gut microbiome profile
Time frame: 12 weeks
Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
Quality of life assessment
Time frame: 12 weeks
Assessed using The Parkinson's Disease Questionnaire (PDQ-39). This 39-item questionnaire assesses how often participants with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Answers are based on a 5-point ordinal scoring system ranging from 0 to 4, with lower scores reflecting a better quality of life.
Parkinsons Disease symptoms
Time frame: 12 weeks
Assessed using the MDS-Unified Parkinson Disease Rating Scale (MDS-UDPRS). The MDS-UPDRS has four parts: I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Higher scores indicate more severe impairment.
Gastrointestinal symptoms
Time frame: 12 weeks
Assessed using the Gastrointestinal Symptom Rating Scale. This 15-item questionnaire uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative option. Higher scores indicate more severe symptoms.
Constipation
Time frame: 12 weeks
Assessed using the Bristol Stool Chart, a diagnostic tool that participants can use to classify their stools based on their appearance. The chart ranges from type 1 (hard) to type 7 (loose, watery) and may identify problems with bowel movements through the shape and consistency of the stool.
7 secondary outcomes
Vitamin B12
Time frame: 12 weeks
Folate
Time frame: 12 weeks
Vitamin B6
Time frame: 12 weeks
Riboflavin
Time frame: 12 weeks
Serum total homocysteine
Time frame: 12 weeks
Vitamin D
Time frame: 12 weeks
Inflammation
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin, B-vitamins and vitamin D in people with Constipation and Parkinson Disease, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary fibre intake (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.