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Fiber Supplement

Fiber Supplements for Constipation in Parkinson's Disease (NRO Trial)

N/A
Waitlist Available
Led By Bobbi Langkamp-Henken, PhD, RD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hoehn & Yahr stage < 4 in the clinical "ON" state
Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each day up to 10 weeks
Awards & highlights

NRO Trial Summary

This trial will compare the effects of two types of fiber supplements on constipation in people with Parkinson's Disease.

Who is the study for?
This trial is for people aged 40-85 with Parkinson's Disease and constipation, who are either not on PD medications or on a stable dose. They should be in the early to mid-stages of the disease (Hoehn & Yahr stage < 4), regularly use laxatives, and can't already be taking fiber supplements or have certain GI diseases other than constipation.Check my eligibility
What is being tested?
The study tests if psyllium or wheat bran affects body weight, nutrition status, and bowel function compared to a placebo (maltodextrin) over an 8-week period in Parkinson's patients with constipation. Participants will take their assigned supplement daily and maintain their usual diet and exercise routines.See study design
What are the potential side effects?
Possible side effects from psyllium or wheat bran may include bloating, gas, cramping, or allergic reactions. Maltodextrin could cause similar digestive issues. Side effects vary by individual.

NRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Parkinson's disease is not in the most advanced stage.
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I haven't taken drugs for my condition or am on a stable drug plan with no changes expected.
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I have been diagnosed with Parkinson's disease by a doctor.
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I have read and understood the consent form in English.
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I can take the study treatment twice daily for 8 weeks.
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I am between 40 and 85 years old.
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I have been regularly using laxatives for the last month.

NRO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each day up to 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and each day up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body weight
Secondary outcome measures
Appetite
Body composition
Constipation-related Quality of Life
+8 more
Other outcome measures
Digestion-related Quality of Life
Physical Activity
Stress

NRO Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PsylliumExperimental Treatment1 Intervention
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.
Group II: Coarse wheat branExperimental Treatment1 Intervention
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.
Group III: MaltodextrinPlacebo Group1 Intervention
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
~610

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,609 Total Patients Enrolled
Bobbi Langkamp-Henken, PhD, RDPrincipal InvestigatorUniversity of Florida
12 Previous Clinical Trials
2,678 Total Patients Enrolled

Media Library

Coarse Wheat Bran (Fiber Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04829760 — N/A
Parkinson's Disease Research Study Groups: Coarse wheat bran, Maltodextrin, Psyllium
Parkinson's Disease Clinical Trial 2023: Coarse Wheat Bran Highlights & Side Effects. Trial Name: NCT04829760 — N/A
Coarse Wheat Bran (Fiber Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04829760 — N/A

Frequently Asked Questions

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

For what demographic is enrollment in this experiment open?

"This clinical trial seeks 79 volunteers suffering from Parkinson's disease, aged between 40 and 85. The mandatory requirements for the study include: no changes in PD medication dosage throughout the duration of the experiment; regular consumption of laxatives over the past month; a physician-confirmed diagnosis of PD; Hoehn & Yahr stage less than 4 in an "ON" state; comprehension and agreement to informed consent provided in English language; maintenance of habitual diet and exercise regimens during study period; twice daily intake of specified treatment over 8 weeks' time frame; completion of various questionnaires and dietary recalls within 10 week timeframe as well as vigorous adherence to"

Answered by AI

Are there still opportunities for individuals to join the experiment?

"Affirmative, the clinical trial is actively recruiting. As seen on clinicaltrials.gov, this study was posted on May 13th 2021 and last updated September 14th 2022 in search of 79 participants at a singular site."

Answered by AI

What is the approximate size of the cohort undergoing this research trial?

"Affirmative. The information provided on clinicaltrials.gov suggests that this medical experiment, which was posted in May 2021 and last edited in September 2022, is actively attempting to recruit 79 participants from a single location."

Answered by AI

Is this investigation permitting elderly individuals to join?

"As per the restrictions outlined in this clinical trial's inclusion criteria, candidates must be between 40 and 85 years old."

Answered by AI
~0 spots leftby Apr 2024