The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorDalin Tzu Chi General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older adults aged 65 to 100 years
Cognitively aware and able to express their opinions
Diagnosed with functional constipation
Disqualifiers
Diagnosis of diabetes mellitus
Cognitive impairment, including moderate to severe dementia or psychiatric disorders
Aphasia
Severe hearing impairment
Trial design
Design model
Factorial
Treatments tested in this trial
Low-Dose Prune Juice
Dietary supplementIntervention Name: Prune Juice 100 mL/day Description: 100 mL prune juice daily (1.07 g dietary fiber), administered once each morning for 4 weeks.
Medium-Dose Prune Juice
Dietary supplementIntervention Name: Prune Juice 150 mL/day Description: 150 mL prune juice daily (1.61 g dietary fiber), administered once each morning for 4 weeks.
High-Dose Prune Juice
Dietary supplementIntervention Name: Prune Juice 200 mL/day Description: 200 mL prune juice daily (3.22 g dietary fiber), administered once each morning for 4 weeks.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Experimental Group 1Experimental treatment 1 intervention
Group B: Experimental Group 2Experimental treatment 1 intervention
Group C: Experimental Group 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS)
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a 7-point scale that classifies stool into 7 types: Type 1 = separate hard lumps Type 7 = entirely liquid Types 3 to 5 are considered normal. The mean change in BSFS score from baseline to Week 4 will be measured. Higher or lower scores reflect changes in stool consistency severity.
Time frame
From study enrollment to the end of the 4-week intervention2
Change in Constipation Symptoms Measured by PAC-SYM
Constipation symptoms will be assessed using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. This instrument includes 12 items across abdominal, stool, and rectal symptom subscales. Each item is rated from 0 (no symptoms) to 4 (very severe). The total score ranges from 0 to 48, with higher scores indicating worse symptoms. The change in total PAC-SYM score from baseline to Week 4 will be evaluated.
Time frame
From study enrollment to the end of the 4-week interventionSponsors and contacts
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Source ClinicalTrials.gov