Parkinson DiseaseRESISTA-PDNCT02784145
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
A study testing Resistant starch and Recommendation with regard to nutrition in people with Parkinson Disease, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Resistant starch and Recommendation with regard to nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Resistant starch, Recommendation with regard to nutrition
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant starchDietary supplement
Recommendation with regard to nutritionOther
Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition
| Study group | Role | What they receive |
|---|---|---|
| RS | Other | Resistant starch supplementation (5 g twice a day) Receives: Dietary Supplement: Resistant starch |
| No RS | Other | 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) Receives: Other: Recommendation with regard to nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel habits
Number of patients with improved bowel habits
Measured: 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)
Measured: 8 weeks
Analysis of fecal microbiota composition
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marcus Unger, Universität des Saarlandes
- Investigators
- Marcus M Unger, PD Dr. med., Principal investigator, Saarladnd University, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784145
- Sponsor's protocol ID
- RESISTA-PD
- Acronym
- RESISTA-PD
- Status last verified
- May 2018
- First submitted
- 17 May 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34839011
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease
- ClinicalTrials.gov ID
- NCT02784145
- Acronym / sponsor ID
- RESISTA-PD / RESISTA-PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RS | Other | Dietary Supplement: Resistant starchResistant starch supplementation (5 g twice a day) |
| No RS | Other | Other: Recommendation with regard to nutritionPD patients who do not receive resistant starch, but who receive recommendations concerning healthy Nutrition (based on the guidelines of the German Society for Nutrition) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant starch | Dietary supplement | RS |
| Recommendation with regard to nutritionSubjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition | Other | No RS |
Primary outcome
Bowel habits
Time frame: 8 weeks
Number of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations
Time frame: 8 weeks
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
Time frame: 8 weeks
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Derived from this study: PubMed 34839011Becker 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.
- Individual participant dataSharing planned: Yes
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus M Unger, PD Dr. med. principal investigator
Saarladnd University, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant starch and Recommendation with regard to nutrition in people with Parkinson Disease, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel habits (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.