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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Change in Stool Consistency Measured by Bristol Stool Form Scale (BSFS) [Срок оценки: From study enrollment to the end of the 4-week intervention]
• Change in Constipation Symptoms Measured by PAC-SYM [Срок оценки: From study enrollment to the end of the 4-week intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Licensed Long-Term Care Institutions in Chiayi Region — Chiayi City

Идентификаторы

NCT: NCT06963125 · B11304037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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