Parkinson Disease
Conditions
Keywords
Nutrition, Dietetics, Fiber, Weight loss, Constipation, Malnutrition, Parkinson's Disease
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPsyllium
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
DIETARY_SUPPLEMENTCoarse wheat bran
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
DIETARY_SUPPLEMENTMaltodextrin
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (\ 2 tablespoons) in two doses each day for 8 weeks
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
A randomized, single-blind, placebo-controlled parallel study in which participants consume 10 grams of psyllium, coarse wheat bran, or a placebo (maltodextrin) for eight weeks.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed Parkinson's disease * Age 40-85 years * Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol * Hoehn & Yahr stage \< 4 in the clinical ON state * Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week) * Complete informed consent in English * Maintain habitual diet and exercise routine throughout study period * Consume the study intervention twice per day during the eight-week intervention period * Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks * Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit
Exclusion criteria
* Atypical or secondary Parkinsonism * Underweight (BMI \<18.5) * Inability to swallow study supplement due to swallowing concerns * Currently using a fiber supplement * Use of another investigational product within 3 months of the screening visit * Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 8 weeks | The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 8 weeks | Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy. |
| Non-motor symptoms | 8 weeks | 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). |
| Parkinson's Disease- related Quality of life | 8 weeks | 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. |
| Handgrip strength | 8 weeks | Changes in upper body strength assessed by handgrip strength via dynamometer |
| Digestive health | Each week up to 10 weeks | 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. |
| Laxative use | Each week up to 10 weeks | Compare laxative use frequency and dosage between groups |
| Stool frequency | Each week up to 10 weeks | Compare the number of stools per week between groups |
| Stool consistency | Each day up to 10 weeks | Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups |
| Appetite | Each week up to 10 weeks | Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ). |
| Nutrition risk | 8 weeks | 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. |
| Constipation-related Quality of Life | 8 weeks | Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 8 weeks | Changes in physical activity assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ assess the intensity of physical activity and sitting time to estimate total physical activity (Metabolic Equivalents-min/week). |
| Digestion-related Quality of Life | Each week up to 10 weeks | Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire. |
| Stress | Each day up to 10 weeks | Changes in daily stress rating on a 10-point severity Likert scale. |
Countries
United States
Outcome results
None listed