The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life

NCT06963125 | Recruiting

• 1 other identifier: B11304037
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation in Older Adults; Functional Constipation in Elderly

Outcome Measures

Primary Outcomes (2)

• 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.

  From study enrollment to the end of the 4-week intervention

• 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.

  From study enrollment to the end of the 4-week intervention

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Dietary Supplement: Low-Dose Prune Juice

Experimental Group 2

EXPERIMENTAL

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Dietary Supplement: Medium-Dose Prune Juice

Experimental Group 3

EXPERIMENTAL

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Dietary Supplement: High-Dose Prune Juice

Interventions

Low-Dose Prune Juice DIETARY_SUPPLEMENT

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.

Experimental Group 1

Medium-Dose Prune Juice DIETARY_SUPPLEMENT

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.

Experimental Group 2

High-Dose Prune Juice DIETARY_SUPPLEMENT

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.

Experimental Group 3

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults aged 65 to 100 years
• Cognitively aware and able to express their opinions
• Diagnosed with functional constipation

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Licensed Long-Term Care Institutions in Chiayi Region

Chiayi City, Chiayi County, 51591, Taiwan

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 8, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)