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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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RS

Resistant starch supplementation (5 g twice a day)

Group Type OTHER

Resistant starch

Intervention Type DIETARY_SUPPLEMENT

No RS

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)

Group Type OTHER

Recommendation with regard to nutrition

Intervention Type OTHER

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

Interventions

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Resistant starch

Intervention Type DIETARY_SUPPLEMENT

Recommendation 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed to participate
* For patients: diagnosis of Parkinson Disease

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes