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Dietary Protein Patterns for Parkinson's Disease
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of idiopathic PD for 5 or more years
45 years or older
Must not have
Untreated sleep apnea
Known narcolepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 weeks. total score ranges from 0-260 with higher scores indicating greater symptom severity.
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of different dietary protein patterns on people with Parkinson's disease.
Who is the study for?
This trial is for people over 45 with Parkinson's Disease diagnosed at least 5 years ago, who are on stable levodopa treatment and have motor fluctuations. It's not for those on special diets, with renal disease, deep brain stimulation, narcolepsy, untreated sleep apnea or any condition that might interfere with the study.
What is being tested?
The study tests how different protein diets affect muscle health and medication effectiveness in Parkinson's patients. One group will follow a Protein Redistribution Diet while another will maintain a consistent protein intake to see which is better.
What are the potential side effects?
Since this trial involves dietary changes rather than medications, side effects may include digestive discomfort or changes in energy levels as the body adjusts to new eating patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease for 5 or more years.
Select...
I am 45 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have sleep apnea that has not been treated.
Select...
I have been diagnosed with narcolepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 5 weeks. total score ranges from 0-260 with higher scores indicating greater symptom severity.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5 weeks. total score ranges from 0-260 with higher scores indicating greater symptom severity.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in handgrip strength
Body Weight Changes
Change in markers of skeletal muscle metabolism GDF15
+2 moreSecondary study objectives
Change in physical activity
Change in total Parkinson symptoms
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Protein Redistribution DietActive Control1 Intervention
PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
Group II: Protein Consistent DietActive Control1 Intervention
PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,832 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney disease.I have been on a consistent levodopa treatment for over 3 months.I have been diagnosed with Parkinson's disease for 5 or more years.I have sleep apnea that has not been treated.I have been diagnosed with narcolepsy.I am 45 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Protein Redistribution Diet
- Group 2: Protein Consistent Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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