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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: Resistant starch; Other: Recommendation with regard to nutrition

• Registration Number: NCT02784145
• Lead Sponsor: Universität des Saarlandes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Status Verified: 2018-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

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

Main

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RS	Resistant starch	Resistant starch supplementation (5 g twice a day)
No RS	Recommendation with regard to nutrition	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)

Primary Outcome Measures

Name	Time	Method
Bowel habits	8 weeks	Number of patients with improved bowel habits
Fecal short chain fatty acid (SCFA) concentrations	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	8 weeks	Analysis to detect changes between baseline and 8 weeks of resistant starch supplementation

Trial Locations

Locations (1)

Saarland University; 🇩🇪 Homburg / Saar, Saarland, Germany