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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease

NCT07213856

Parkinsons Disease (PD) Constipation - Functional

NOT_YET_RECRUITING NA

Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation

NCT04837313

Parkinson's Disease Fecal Microbiota Transplantation

RECRUITING NA

Pre-biotics and Probiotics for Constipation in Parkinson's Disease

NCT02459717

Constipation

COMPLETED NA

The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

NCT04829760

Parkinson Disease

COMPLETED NA

Ketogenic Diets for Symptoms of Parkinson's Disease

NCT01364545

Parkinson's Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary Supplement (Functional drink)

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

Group Type ACTIVE_COMPARATOR

Inulin, B-vitamins and vitamin D

Intervention Type DIETARY_SUPPLEMENT

Intervention twice daily with:

10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D

Placebo drink

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.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

A twice daily placebo drink with similar energy content but without the additional nutrient provision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inulin, B-vitamins and vitamin D

Intervention twice daily with:

10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D

Intervention Type DIETARY_SUPPLEMENT

Placebo group

A twice daily placebo drink with similar energy content but without the additional nutrient provision

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of Parkinson Disease (PD)
* Aged ≥18 years
* Individuals with the capacity to provide informed consent

Exclusion Criteria

* 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)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No