Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease (RESISTA-PD)

May 9, 2018 updated by: Dr. Marcus Unger, Universität des Saarlandes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg / Saar, Saarland, Germany, 66421
        • Saarland University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RS
Resistant starch supplementation (5 g twice a day)
Dietary supplement: Resistant starch
Other: 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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel habits
Time Frame: 8 weeks
Number of patients with improved bowel habits
8 weeks
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)
8 weeks
Analysis of fecal microbiota composition
Time Frame: 8 weeks
Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Investigators

  • Principal Investigator: Marcus M Unger, PD Dr. med., Saarladnd University, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESISTA-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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