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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Dr. Marcus Unger, Saarland University
Sponsor:
Information provided by (Responsible Party):
Dr. Marcus Unger, Saarland University
ClinicalTrials.gov Identifier:
NCT02784145
First received: May 17, 2016
Last updated: February 9, 2017
Last verified: February 2017
  Purpose

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.

Condition Intervention
Parkinson Disease
Dietary Supplement: Resistant starch
Other: Recommendation with regard to nutrition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Dr. Marcus Unger, Saarland University:

Primary Outcome Measures:
  • 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 by quantitative polymerase chain reaction assay (PCR) [ Time Frame: 8 weeks ]
    Descriptive analysis to detect changes between baseline and 8 weeks of resistant starch supplementation


Estimated Enrollment: 100
Study Start Date: May 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RS
Resistant starch supplementation (5 g twice a day)
Dietary Supplement: Resistant starch
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02784145

Contacts
Contact: Marcus M. Unger, PD Dr. med. + 49 6841 16 24322 marcus.unger@uks.eu

Locations
Germany
Saarland University Recruiting
Homburg / Saar, Saarland, Germany, 66421
Contact: Marcus M Unger, MD    +49 6841 16 24322    marcus.unger@uks.eu   
Principal Investigator: Marcus M Unger, MD         
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Marcus M Unger, PD Dr. med. Saarladnd University, Department of Neurology
  More Information

Responsible Party: Dr. Marcus Unger, PD Dr., Saarland University
ClinicalTrials.gov Identifier: NCT02784145     History of Changes
Other Study ID Numbers: RESISTA-PD
Study First Received: May 17, 2016
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 25, 2017