The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

Parkinson Disease Clinical Trial

— NRO  

Official title:

The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829760
• Other study ID #: IRB202100363
• Status: Completed
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: April 28, 2024

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Constipation
• Parkinson Disease

Intervention

Dietary Supplement:
• Psyllium
Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
• Coarse wheat bran
Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
• Maltodextrin
Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Stress	Changes in daily stress rating on a 10-point severity Likert scale.	Each day up to 10 weeks
Other	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
Primary	Body weight	The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.	8 weeks
Secondary	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
Secondary	Laxative use	Compare laxative use frequency and dosage between groups	Each week up to 10 weeks
Secondary	Stool frequency	Compare the number of stools per week between groups	Each week up to 10 weeks
Secondary	Stool consistency	Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups	Each day up to 10 weeks
Secondary	Body composition	Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.	8 weeks
Secondary	Appetite	Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).	Each week up to 10 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Handgrip strength	Changes in upper body strength assessed by handgrip strength via dynamometer	8 weeks