The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Dose Prune Juice, Medium-Dose Prune Juice, High-Dose Prune Juice.
- Who it may be relevant to
- Registry conditions: Constipation in Older Adults, Functional Constipation in Elderly. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Different Doses of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life Among Older Adults in Long-Term Care Facilities
Overview
This study investigates the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life in older adults. Using a factorial experimental design, 90 participants aged 65 to 100 with functional constipation will be randomly assigned to receive 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The study aims to determine a safe and effective dosage for constipation management, offering a non-pharmacological approach to improving bowel health in older adults.
Detailed description
Constipation is a prevalent issue among older adults, leading to physical discomfort and long-term health complications. Non-pharmacological interventions are essential for effective management. This study aims to compare the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life to determine a safe and effective dosage for older adults. A factorial experimental design will be employed, with 90 participants aged 65 to 100 who are conscious, able to express their opinions, and diagnosed with functional constipation. Participants will be randomly assigned to three groups receiving 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The outcomes will be assessed at five time points: before the intervention (T0), after one week (T1), after two weeks (T2), after three weeks (T3), and after four weeks (T4).
Interventions
- Dietary supplement Low-Dose Prune Juice
Intervention Name: Prune Juice 100 mL/day Description: 100 mL prune juice daily (1.07 g dietary fiber), administered once each morning for 4 weeks. - Dietary supplement Medium-Dose Prune Juice
Intervention Name: Prune Juice 150 mL/day Description: 150 mL prune juice daily (1.61 g dietary fiber), administered once each morning for 4 weeks. - Dietary supplement High-Dose Prune Juice
Intervention Name: Prune Juice 200 mL/day Description: 200 mL prune juice daily (3.22 g dietary fiber), administered once each morning for 4 weeks.
Primary outcome measures
- Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS) [Time frame: From study enrollment to the end of the 4-week intervention]
- Change in Constipation Symptoms Measured by PAC-SYM [Time frame: From study enrollment to the end of the 4-week intervention]
Eligibility criteria
Inclusion criteria
- Older adults aged 65 to 100 years
- Cognitively aware and able to express their opinions
- Diagnosed with functional constipation
Exclusion criteria
- Diagnosis of diabetes mellitus
- Cognitive impairment, including moderate to severe dementia or psychiatric disorders
- Aphasia
- Severe hearing impairment
- Presence of gastrointestinal diseases, including:
- Gastrointestinal bleeding
- Intestinal obstruction
- Abdominal tumors
- Irritable bowel syndrome
- Acute diverticulitis
- Diarrhea
- Crohn's disease
- Ulcerative colitis
- History of abdominal surgery
- Regular use of probiotics
- Regular use of traditional Chinese medicine or folk remedies for constipation relief
- Difficulty swallowing or risk of aspiration
- Major illnesses, such as current cancer treatment or severe cardiovascular diseases
- Currently hospitalized
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Licensed Long-Term Care Institutions in Chiayi Region — Chiayi City
Identifiers
NCT: NCT06963125 · B11304037