Back to resultsEffects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease (RESISTA-PD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Resistant starch
Recommendation with regard to nutrition
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
Main Inclusion Criteria:
- Written informed to participate
- For patients: diagnosis of Parkinson Disease
Main Exclusion Criteria:
- Use of antibiotics, steroids or probiotic supplements
- Chronic or acute disorders of the gastrointestinal tract
- History of gastrointestinal surgery (other than appendectomy)
- For healthy controls: Family history of neurodegenerative disorders
Sites / Locations
- Saarland University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
RS
No RS
Arm Description
Resistant starch supplementation (5 g twice a day)
PD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition)
Outcomes
Primary Outcome Measures
Bowel habits
Number of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations
Number of patients with either a) increased, b.) unaltered or c) decreased concentration of short chain fatty acids in fecal samples at 8 weeks (compared to baseline)
Analysis of fecal microbiota composition
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784145
Brief Title
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
Acronym
RESISTA-PD
Official Title
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:
symptoms of constipation (assessed by clinical scores);
fecal short chain fatty acid concentrations (measured by chromatography);
gut microbiota composition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RS
Arm Type
Other
Arm Description
Resistant starch supplementation (5 g twice a day)
Arm Title
No RS
Arm Type
Other
Arm Description
PD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition)
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant starch
Intervention Type
Other
Intervention Name(s)
Recommendation with regard to nutrition
Intervention Description
Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition
Primary Outcome Measure Information:
Title
Bowel habits
Description
Number of patients with improved bowel habits
Time Frame
8 weeks
Title
Fecal short chain fatty acid (SCFA) concentrations
Description
Number of patients with either a) increased, b.) unaltered or c) decreased concentration of short chain fatty acids in fecal samples at 8 weeks (compared to baseline)
Time Frame
8 weeks
Title
Analysis of fecal microbiota composition
Description
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria:
Written informed to participate
For patients: diagnosis of Parkinson Disease
Main Exclusion Criteria:
Use of antibiotics, steroids or probiotic supplements
Chronic or acute disorders of the gastrointestinal tract
History of gastrointestinal surgery (other than appendectomy)
For healthy controls: Family history of neurodegenerative disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus M Unger, PD Dr. med.
Organizational Affiliation
Saarladnd University, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saarland University
City
Homburg / Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
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