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

Universität des Saarlandes

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Recommendation with regard to nutrition; Dietary Supplement: Resistant starch

Study type: Interventional

Funder types: Other

Identifiers

NCT02784145

RESISTA-PD

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

RS

Other group

Description:

Resistant starch supplementation (5 g twice a day)

Treatment:

Dietary Supplement: Resistant starch

No RS

Other group

Description:

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)

Treatment:

Other: Recommendation with regard to nutrition