This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
35
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (\~2 tablespoons) in two doses each day for 8 weeks
University of Florida
Gainesville, Florida, United States
Body weight
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
Time frame: 8 weeks
Digestive health
Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale, which is composed of 15 questions related to 5 syndromes: constipation, diarrhea, reflux, abdominal pain, and indigestion. Individual syndrome scores will be summed for a total score.
Time frame: Each week up to 10 weeks
Laxative use
Compare laxative use frequency and dosage between groups
Time frame: Each week up to 10 weeks
Stool frequency
Compare the number of stools per week between groups
Time frame: Each week up to 10 weeks
Stool consistency
Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups
Time frame: Each day up to 10 weeks
Body composition
Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.
Time frame: 8 weeks
Appetite
Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).
Time frame: Each week up to 10 weeks
Nutrition risk
Changes in nutrition risk determined by the Patient Generated- Subjective Global Assessment (PG-SGA). The PG-SGA is a tool that helps clinicians determine nutrition risk by considering weight changes, changes in dietary intake, presence of nutrition impact symptoms, physical activity, comorbidities, metabolic demands, and an assessment of lean mass, fat mass, and edema.
Time frame: 8 weeks
Constipation-related Quality of Life
Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.
Time frame: 8 weeks
Non-motor symptoms
Compare non-motor symptom severity and frequency over the past 1 month will be captured by the Non-Motor Symptom Scale for Parkinson's Disease (NMSS).
Time frame: 8 weeks
Parkinson's Disease- related Quality of life
Changes in quality of life assessed by the Parkinson's disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39 questionnaire tool that assesses quality of life within the domains of activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, and social support.
Time frame: 8 weeks
Handgrip strength
Changes in upper body strength assessed by handgrip strength via dynamometer
Time frame: 8 weeks
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