Coarse wheat bran for Parkinson Disease

1
Effectiveness
1
Safety
University of Florida, Gainesville, FL
Parkinson Disease+2 More
Coarse wheat bran - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether fiber supplements may help improve constipation for individuals with Parkinson's disease.

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Eligible Conditions

  • Parkinson Disease
  • Body Weight
  • Dyschezia
  • Constipation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Coarse wheat bran will improve 1 primary outcome, 11 secondary outcomes, and 3 other outcomes in patients with Parkinson Disease. Measurement will happen over the course of 8 weeks.

8 weeks
Body composition
Body weight
Constipation-related Quality of Life
Handgrip strength
Non-motor symptoms
Nutrition risk
Parkinson's Disease- related Quality of life
Physical Activity
Week 10
Stool consistency
Stress
Week 10
Appetite
Digestion-related Quality of Life
Digestive health
Laxative use
Stool frequency

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Maltodextrin
Psyllium
Placebo group

This trial requires 79 total participants across 3 different treatment groups

This trial involves 3 different treatments. Coarse Wheat Bran is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Psyllium
DietarySupplement
10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to at least 8 ounces (240 mL) of cold water or a beverage that is typically consumed. Participants will ingest the intervention each morning and evening for eight weeks.
Coarse wheat bran
DietarySupplement
10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to a food they normally eat.
Maltodextrin
DietarySupplement
Volume equivalent to the psyllium. Participants will be instructed to divide the daily dose into 2 doses and ingest by adding the product to a food or to 8 ounces (240 mL) of a beverage that is typically consumed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psyllium
2015
Completed Phase 4
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: each day up to 10 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly each day up to 10 weeks for reporting.

Closest Location

University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Fill out questionnaires and dietary recalls on a daily and weekly basis for approximately 10 weeks. show original
Do not drink or eat anything (except water, coffee, or tea) for at least 12 hours before each study visit. show original
Physician-diagnosed Parkinson's disease
Age 40-85 years
Someone who is not taking any drugs for Parkinson's disease, or someone who is taking the same drugs at the same dosage for at least six months before the study. show original
Hoehn & Yahr stage < 4 in the clinical "ON" state
I have been using laxatives regularly over the past month. show original
Complete informed consent in English
Keep up your usual diet and exercise routine throughout the study period. show original
Consume the study intervention twice per day during the eight-week intervention period

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can parkinson disease be cured?

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Parkinson disease, like any other condition of PD, cannot really be cured, even with a new therapeutic approach; but the motor symptoms can be controlled to a great extent and some disease signs, such as tremor, rigidity, postural instability and cognitive dysfunction, are reduced. The need to find a perfect motor treatment to cure PD is overrated, even in the field of clinical research.

Unverified Answer

How many people get parkinson disease a year in the United States?

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In 2001, around 1.5 million people in the United States had Parkinson disease. Although the prevalence of Parkinson disease may be on the rise, it is uncertain if this is the result of an increase in prevalence of Parkinson disease as an underlying condition or to increased awareness.

Unverified Answer

What causes parkinson disease?

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The main cause of PD is a problem within the cells of the brain and spinal cord. The problem arises from proteins (protein misfolding) in their genetic material not making the right proteins in a certain place, usually the dopaminergic neurons of the brain. This malfunctioning protein-producing issue is caused by the body trying to protect itself against diseases or poisons. We must help our body to make these right proteins, to give the brain the protection it needs.

Unverified Answer

What are the signs of parkinson disease?

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For parkinsonian patients, symptoms can be classified according to their aetiology. Clinicians usually classify PD based on symptomatology, such as tremor (tremors only or generalised tremor) and posture; however, some features can be used for patient prognosis.

Unverified Answer

What are common treatments for parkinson disease?

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Most commonly used treatments for parkinsonism are listed below. It is important to know where these therapies are prescribed since there are many [forms of treatment] that can be applied.\n1. Non-toxic substances: Levodopa/Carbidopa/benserazide is the drug of choice for most of the PD patients. But can be troublesome to patients because they suffer some [losing of function] by having its pharmacological effects or adverse side effect.\n2. Stimulants: The medication dopamine affects the [movement] function.

Unverified Answer

What is parkinson disease?

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PD affects 0.5–1% of the population and is characterized by slow, progressive and unrelenting motor symptoms including bradykinesia, dyskinesia, rigidity, and tremor. The hallmark symptoms of PD include resting tremor in the postural limbs, bradykinesia, and shuffling gait. More than half of people lose motor control and the overall mortality rate is about 20%.\n

Unverified Answer

What is the primary cause of parkinson disease?

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The evidence that does exists shows significant overlap between both PD and PDD, although the two terms are not synonymous. PDD exists by itself. It is therefore not a secondary condition, but rather a discrete entity, that occurs independently of PD. This would include PDD caused by PD, that is PDD-PD, as well as PDD caused by PD without PD, that is PDD-only. There is no universally agreed terminology for PDD. The simplest is to describe all the symptoms of PD and PDD using the same term: PD.

Unverified Answer

What is coarse wheat bran?

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Results from a recent paper revealed that coarse wheat bran could be used as a functional fiber additive in the food products. Since coarse wheat bran contains phytic acid, it should be consumed cautiously and its intake should be limited by restricting phytic acid and fiber sources like whole wheat flour, wheat flour bran, or refined sugar.

Unverified Answer

Is coarse wheat bran safe for people?

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The study found that coarse wheat bran was not associated with an increased risk of adverse effects. This is reassuring both for the public and for the wheat industry which, in addition to their traditional use in bread making, have now introduced coarse wheat bran into diets of consumers.

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What is the latest research for parkinson disease?

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Results from a recent clinical trial from the latest studies are encouraging, and this may open a new strategy for Parkinson's disease, which will help improve the quality of life in Parkinson's and increase patient safety.

Unverified Answer

Is coarse wheat bran typically used in combination with any other treatments?

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Coarse wheat bran is the most frequently reported ingredient of PD food preparations. No clinical information as to the quality of products labelled as coarse wheat bran is available. However, the results have some importance for clinicians. In order to improve PD patients' daily life, food products must be clearly identified, to allow proper intake and follow-up or rehabilitation.

Unverified Answer

How serious can parkinson disease be?

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Older adults should consider the importance of routine evaluation and treatment for early stages of parkinson disease, especially for those with cognitive or functional impairment. Since more advanced cases can have serious, and often permanent, consequences, screening for early disease is critical.

Unverified Answer
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