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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Constipation in Older Adults; Functional Constipation in Elderly
• Intervention / Treatment: Dietary supplement: Low-Dose Prune Juice; Dietary supplement: Medium-Dose Prune Juice; Dietary supplement: High-Dose Prune Juice

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).

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi County
    • Chiayi City, Chiayi County, Taiwan, 51591
      • Recruiting
      • Licensed Long-Term Care Institutions in Chiayi Region
      • Contact: Li-Zhen Lin; Phone Number: 05-264-8000; Email: lin.lone1118@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1; 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; 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: Experimental Group 2; 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; 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: Experimental Group 3; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dalin Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 8, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: B11304037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns and the absence of a data-sharing infrastructure at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No