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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psyllium | Experimental | 10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to at least 8 ounces (240 mL) of cold water or a beverage that is typically consumed. Participants will ingest the intervention each morning and evening for eight weeks. |
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| Coarse wheat bran | Experimental | 10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to a food they normally eat. |
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| Maltodextrin | Placebo Comparator | Volume equivalent to the psyllium. Participants will be instructed to divide the daily dose into 2 doses and ingest by adding the product to a food or to 8 ounces (240 mL) of a beverage that is typically consumed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium | Dietary Supplement | Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each week up to 10 weeks |
| Laxative use |
| Measure | Description | Time Frame |
|---|---|---|
| Digestion-related Quality of Life | Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire. | Each week up to 10 weeks |
| Stress | Changes in daily stress rating on a 10-point severity Likert scale. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D015431 | Weight Loss |
| D003248 | Constipation |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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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.
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| Coarse wheat bran | Dietary Supplement | Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks |
|
| Maltodextrin | Dietary Supplement | Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks |
|
Compare laxative use frequency and dosage between groups |
| Each week up to 10 weeks |
| Stool frequency | Compare the number of stools per week between groups | Each week up to 10 weeks |
| Stool consistency | Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups | Each day up to 10 weeks |
| Body composition | Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy. | 8 weeks |
| Appetite | Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ). | 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. | 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. | 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). | 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. | 8 weeks |
| Handgrip strength | Changes in upper body strength assessed by handgrip strength via dynamometer | 8 weeks |
| Each day up to 10 weeks |
| Physical Activity | 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). | 8 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |