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Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02784145
Acronym
RESISTA-PD
Enrollment
95
Registered
2016-05-26
Start date
2016-05-31
Completion date
2018-05-31
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DIETARY_SUPPLEMENTResistant starch
OTHERRecommendation with regard to nutrition

Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition

Sponsors

Universität des Saarlandes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Bowel habits8 weeksNumber of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations8 weeksNumber 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 composition8 weeksAnalysis to detect changes between baseline and 8 weeks of resistant starch supplementation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026