Parkinson DiseaseNRONCT04829760
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
A study testing Psyllium, Coarse wheat bran and Maltodextrin in people with Parkinson Disease, run by University of Florida at 1 site in United States.
Trial summary
This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Psyllium, Coarse wheat bran and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed Parkinson's disease
- Age 40-85 years
- Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
- Hoehn \& Yahr stage < 4 in the clinical "ON" state
- Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
- Complete informed consent in English
Show all 10Show fewer
- Maintain habitual diet and exercise routine throughout study period
- Consume the study intervention twice per day during the eight-week intervention period
- Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks
- Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit
Who cannot join
- Atypical or secondary Parkinsonism
- Underweight (BMI <18.5)
- Inability to swallow study supplement due to swallowing concerns
- Currently using a fiber supplement
- Use of another investigational product within 3 months of the screening visit
- Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
Trial locations and contacts
1 site in 1 country.
About this study
This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.
- Conditions
- Parkinson Disease
- Being tested
- Psyllium, Coarse wheat bran, Maltodextrin
- Keywords
- Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Weight Loss, Constipation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
Coarse wheat branDietary supplement
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
MaltodextrinDietary supplement
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Experimental | 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. Receives: Dietary Supplement: Psyllium |
| Coarse wheat bran | Experimental | 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. Receives: Dietary Supplement: Coarse wheat bran |
| Maltodextrin | Placebo comparator | 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. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
Measured: 8 weeks
Secondary outcomes (11)
Digestive health
Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale, which is composed of 15 questions related to 5 syndromes: constipation, diarrhea, reflux, abdominal pain, and indigestion. Individual syndrome scores will be summed for a total score.
Measured: Each week up to 10 weeks
Laxative use
Compare laxative use frequency and dosage between groups
Measured: Each week up to 10 weeks
Stool frequency
Compare the number of stools per week between groups
Measured: Each week up to 10 weeks
Stool consistency
Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Measured: Each day up to 10 weeks
Body composition
Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Measured: 8 weeks
Appetite
Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Measured: Each week up to 10 weeks
Nutrition risk
Changes in nutrition risk determined by the Patient Generated- Subjective Global Assessment (PG-SGA). The PG-SGA is a tool that helps clinicians determine nutrition risk by considering weight changes, changes in dietary intake, presence of nutrition impact symptoms, physical activity, comorbidities, metabolic demands, and an assessment of lean mass, fat mass, and edema.
Measured: 8 weeks
Constipation-related Quality of Life
Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Measured: 8 weeks
Non-motor symptoms
Compare non-motor symptom severity and frequency over the past 1 month will be captured by the Non-Motor Symptom Scale for Parkinson's Disease (NMSS).
Measured: 8 weeks
Parkinson's Disease- related Quality of life
Changes in quality of life assessed by the Parkinson's disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39 questionnaire tool that assesses quality of life within the domains of activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, and social support.
Measured: 8 weeks
Handgrip strength
Changes in upper body strength assessed by handgrip strength via dynamometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start13 May 2021
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blind, placebo-controlled parallel study in which participants consume 10 grams of psyllium, coarse wheat bran, or a placebo (maltodextrin) for eight weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829760
- Sponsor's protocol ID
- IRB202100363
- Acronym
- NRO
- Status last verified
- Jun 2024
- First submitted
- 31 Mar 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
- ClinicalTrials.gov ID
- NCT04829760
- Acronym / sponsor ID
- NRO / IRB202100363
- Conditions
- Parkinson Disease
- Keywords
- Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 2 Apr 2021 (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.
This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A randomized, single-blind, placebo-controlled parallel study in which participants consume 10 grams of psyllium, coarse wheat bran, or a placebo (maltodextrin) for eight weeks.
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Experimental | Dietary Supplement: Psyllium10 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 | Experimental | Dietary Supplement: Coarse wheat bran10 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 | Placebo comparator | Dietary Supplement: MaltodextrinVolume 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician-diagnosed Parkinson's disease
- Age 40-85 years
- Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
- Hoehn \& Yahr stage < 4 in the clinical "ON" state
- Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
Key exclusion criteria (6 listed)
- Atypical or secondary Parkinsonism
- Underweight (BMI <18.5)
- Inability to swallow study supplement due to swallowing concerns
- Currently using a fiber supplement
- Use of another investigational product within 3 months of the screening visit
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 |
|---|---|---|
| PsylliumParticipants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks | Dietary supplement | Psyllium |
| Coarse wheat branParticipants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks | Dietary supplement | Coarse wheat bran |
| MaltodextrinParticipants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks | Dietary supplement | Maltodextrin |
Primary outcome
Body weight
Time frame: 8 weeks
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
11 secondary outcomes
Digestive health
Time frame: Each week up to 10 weeks
Laxative use
Time frame: Each week up to 10 weeks
Stool frequency
Time frame: Each week up to 10 weeks
Stool consistency
Time frame: Each day up to 10 weeks
Body composition
Time frame: 8 weeks
Appetite
Time frame: Each week up to 10 weeks
Nutrition risk
Time frame: 8 weeks
Constipation-related Quality of Life
Time frame: 8 weeks
Non-motor symptoms
Time frame: 8 weeks
Parkinson's Disease- related Quality of life
Time frame: 8 weeks
Handgrip strength
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium, Coarse wheat bran and Maltodextrin in people with Parkinson Disease, run by University of Florida at 1 site in United States.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jun 2024. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body weight (time frame: 8 weeks). 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 20 Jun 2024.