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Completed

NCT Number: NCT04829760

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

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Body Weight Body Weight Changes Brain Diseases Central Nervous System Diseases Constipation Malnutrition Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Synucleinopathies Weight Loss

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyllium

Dietary Supplement

Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks

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

Primary outcomes

  1. Body weight

    Time frame: 8 weeks

    The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.

Secondary outcomes

  1. Digestive health

    Time frame: 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.

  2. Laxative use

    Time frame: Each week up to 10 weeks

    Compare laxative use frequency and dosage between groups

  3. Stool frequency

    Time frame: Each week up to 10 weeks

    Compare the number of stools per week between groups

  4. Stool consistency

    Time frame: Each day up to 10 weeks

    Compare stool consistency, as measured by the Bristol Stool Form Scale, between groups

  5. Body composition

    Time frame: 8 weeks

    Changes in muscle, fat mass, and total body water assessed by bioelectrical impedance spectroscopy.

  6. Appetite

    Time frame: Each week up to 10 weeks

    Changes in appetite will be assessed weekly using the Council on Nutrition Appetite Questionnaire (CNAQ).

  7. Nutrition risk

    Time frame: 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.

  8. Constipation-related Quality of Life

    Time frame: 8 weeks

    Changes in quality of life related to constipation assessed by the Patient Assessment of Constipation- Quality of Life questionnaire.

  9. Non-motor symptoms

    Time frame: 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).

  10. Parkinson's Disease- related Quality of life

    Time frame: 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.

  11. Handgrip strength

    Time frame: 8 weeks

    Changes in upper body strength assessed by handgrip strength via dynamometer

Other outcomes

  1. Digestion-related Quality of Life

    Time frame: Each week up to 10 weeks

    Changes in quality of life related to digestion assessed by the Digestion-associated Quality of life Questionnaire.

  2. Stress

    Time frame: Each day up to 10 weeks

    Changes in daily stress rating on a 10-point severity Likert scale.

  3. Physical Activity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: NRO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2021
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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