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

NCT ID: NCT06963125

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2026-11-30

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.

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).

Conditions

Constipation in Older Adults; Functional Constipation in Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Dose Prune Juice

Intervention Type: 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 1

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

Group Type: EXPERIMENTAL

Low-Dose Prune Juice

Intervention Type: 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 2

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

Group Type: EXPERIMENTAL

Medium-Dose Prune Juice

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalin Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Licensed Long-Term Care Institutions in Chiayi Region

Chiayi City, Chiayi County, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Li-Zhen Lin

Role: primary

lin.lone1118@gmail.com

05-264-8000

Other Identifiers

B11304037

Identifier Type: -

Identifier Source: org_study_id