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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 below
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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:
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I have sleep apnea that has not been treated.
Select...
I have been diagnosed with 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 weeks. total score ranges from 0-260 with higher scores indicating greater symptom severity. for reporting.

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 more
Secondary 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

Protein Redistribution Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05437640 — N/A
Parkinson's Disease Research Study Groups: Protein Redistribution Diet, Protein Consistent Diet
Parkinson's Disease Clinical Trial 2023: Protein Redistribution Diet Highlights & Side Effects. Trial Name: NCT05437640 — N/A
Protein Redistribution Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05437640 — N/A
~0 spots leftby Nov 2024