Trial Outcomes & Findings for Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease (NCT NCT05437640)
NCT ID: NCT05437640
Last Updated: 2025-06-15
Results Overview
Serum Growth Differentiation Factor 15 (GDF15)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline to 5 weeks
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
Protein Consistent Diet, Then Protein Redistribution Diet
PD participants first were randomized to follow the Protein Consistent Diet for 2 weeks. After a washout period of 2 weeks, they then followed by a Protein Redistribution Diet.
|
Protein Redistribution Diet, Then Protein Consistent Diet
PD participants first were randomized to follow a Protein Redistribution diet. After a washout period of 2 weeks, they then followed a Protein Consistent Diet.
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
6
|
6
|
|
First Intervention (2 Weeks)
COMPLETED
|
6
|
6
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
6
|
6
|
|
Washout (1 Week)
COMPLETED
|
5
|
6
|
|
Washout (1 Week)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
5
|
6
|
|
Second Intervention (2 Weeks)
COMPLETED
|
5
|
6
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Protein Consistent Diet, Then Protein Redistribution Diet
PD participants first were randomized to follow the Protein Consistent Diet for 2 weeks. After a washout period of 2 weeks, they then followed by a Protein Redistribution Diet.
|
Protein Redistribution Diet, Then Protein Consistent Diet
PD participants first were randomized to follow a Protein Redistribution diet. After a washout period of 2 weeks, they then followed a Protein Consistent Diet.
|
|---|---|---|
|
Washout (1 Week)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Baseline characteristics by cohort
| Measure |
Total Participants
n=11 Participants
All participants were scheduled to follow both dietary interventions. One participant withdrew during the washout phase. Enrolled n=12, final n=11
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 weeksSerum Growth Differentiation Factor 15 (GDF15)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 5 weeksSerum Fibroblast Growth Factor 21 (FGF21)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 5 weeksHandgrip strength assessed via digital dynamometer
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 5 weeksSleep efficiency assessed via actigraphy
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 5 weeksMotor symptoms assessed via the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. Part II ranges from 0-52 with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Protein Redistribution Diet
n=11 Participants
PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
Protein Redistribution Diet: PD participants will be instructed by a Registered Dietitian to consume 10 grams or less of protein until their evening meal. They will then consume a high protein evening meal to meet their protein needs. They will receive one-on-one education and supportive materials to follow diet plan.
|
Protein Consistent Diet
n=12 Participants
PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Protein Consistent Diet: PD participants will be instructed by a Registered Dietitian to consume 20-30 grams of protein per meal. They will receive one-on-one education and supportive materials to follow diet plan.
|
|---|---|---|
|
Change in Motor Symptoms
Baseline
|
11.27 Score
Standard Deviation 5.57
|
9.58 Score
Standard Deviation 7.75
|
|
Change in Motor Symptoms
Post-Diet
|
9.45 Score
Standard Deviation 5.97
|
9.42 Score
Standard Deviation 4.94
|
SECONDARY outcome
Timeframe: Baseline to 5 weeksPhysical activity assessed via actigraphy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity.Parkinson-related symptoms assessed by total MDS-UPDRS score
Outcome measures
| Measure |
Protein Redistribution Diet
n=11 Participants
PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
Protein Redistribution Diet: PD participants will be instructed by a Registered Dietitian to consume 10 grams or less of protein until their evening meal. They will then consume a high protein evening meal to meet their protein needs. They will receive one-on-one education and supportive materials to follow diet plan.
|
Protein Consistent Diet
n=12 Participants
PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Protein Consistent Diet: PD participants will be instructed by a Registered Dietitian to consume 20-30 grams of protein per meal. They will receive one-on-one education and supportive materials to follow diet plan.
|
|---|---|---|
|
Change in Total Parkinson Symptoms
Post-Diet
|
47.18 score on a scale
Standard Deviation 19.15
|
48.75 score on a scale
Standard Deviation 20.52
|
|
Change in Total Parkinson Symptoms
Baseline
|
52.09 score on a scale
Standard Deviation 20.92
|
51.17 score on a scale
Standard Deviation 21.04
|
Adverse Events
Protein Consistent Diet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Protein Redistribution Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Protein Consistent Diet
n=12 participants at risk
PD participants will be instructed by a Registered Dietitian to consume 20-30 grams of protein per meal. They will receive one-on-one education and supportive materials to follow diet plan.
One participant withdrew during the washout phase after completing the Protein Consistent Diet.
|
Protein Redistribution Diet
n=12 participants at risk
PD participants will be instructed by a Registered Dietitian to consume 10 grams or less of protein until their evening meal. They will then consume a high protein evening meal to meet their protein needs. They will receive one-on-one education and supportive materials to follow diet plan.
No participants experienced adverse events in PRD phase.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
8.3%
1/12 • Number of events 1 • Adverse event information was assessed during the study period (5 weeks)
|
0.00%
0/12 • Adverse event information was assessed during the study period (5 weeks)
|
|
General disorders
Migraines
|
8.3%
1/12 • Number of events 1 • Adverse event information was assessed during the study period (5 weeks)
|
0.00%
0/12 • Adverse event information was assessed during the study period (5 weeks)
|
Additional Information
Dr. Christine Ferguson
University of Alabama at Birmingham
Phone: 205-934-7773
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place