Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
RESISTA-PD
1 other identifier
interventional
95
1 country
1
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:
- 1.symptoms of constipation (assessed by clinical scores);
- 2.fecal short chain fatty acid concentrations (measured by chromatography);
- 3.gut microbiota composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 15, 2018
May 1, 2018
2 years
May 17, 2016
May 9, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Bowel habits
Number of patients with improved bowel habits
8 weeks
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)
8 weeks
Analysis of fecal microbiota composition
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
8 weeks
Study Arms (2)
RS
OTHERResistant starch supplementation (5 g twice a day)
No RS
OTHERPD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition)
Interventions
Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition
Eligibility Criteria
You may qualify if:
- Written informed to participate
- For patients: diagnosis of Parkinson Disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saarland University
Homburg / Saar, Saarland, 66421, Germany
Related Publications (1)
Becker A, Schmartz GP, Groger L, Grammes N, Galata V, Philippeit H, Weiland J, Ludwig N, Meese E, Tierling S, Walter J, Schwiertz A, Spiegel J, Wagenpfeil G, Fassbender K, Keller A, Unger MM. Effects of Resistant Starch on Symptoms, Fecal Markers, and Gut Microbiota in Parkinson's Disease - The RESISTA-PD Trial. Genomics Proteomics Bioinformatics. 2022 Apr;20(2):274-287. doi: 10.1016/j.gpb.2021.08.009. Epub 2021 Nov 25.
PMID: 34839011DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus M Unger, PD Dr. med.
Saarladnd University, Department of Neurology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr.
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 26, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 15, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share