Efficacy of Oral Nutritional Supplement in Community-Dwelling Adults Following Acute Care

Официальное название

Efficacy of Oral Nutritional Supplementation Added to Usual Care in Community-dwelling Adults at Risk of Malnutrition and With Low Muscle Strength Following Acute Care

Обзор

The study aims to determine the effects of Oral Nutritional Supplement (ONS) added to usual care on body weight compared with usual care alone in community-dwelling adults aged 55 years and older who are at risk of malnutrition and have low muscle strength following acute care. Participants randomized to receive either ONS twice daily for 180 days plus usual care, or usual care alone. Usual care includes individualized dietary counseling and standardized physical activity advice provided. The study will assess body weight, nutritional status, muscle strength, physical function, dietary intake, and safety outcomes.

Вмешательства

• Пищевая добавка ONS
  230 mL per serving, twice daily
• Другое Standard of Care (SOC)
  Dietary counseling and physical activity advice

Первичные конечные точки

• Change in body weight [Срок оценки: Day 0 to Day 180]

Вторичные конечные точки (12)

• Change in body weight [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Body mass index (BMI) [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Calf circumference [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Mid-upper arm circumference (MUAC) [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Body composition [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Nutrition Risk [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Handgrip strength [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Short Physical Performance Battery (SPPB) total score [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Short Physical Performance Battery (SPPB) component scores [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• 4-meter gait speed [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Chair stand time [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]
• Energy, macronutrient and micronutrient intakes [Срок оценки: Study Day 30, Study Day 90 and Study Day 180]

Критерии участия

Критерии включения

• At risk of malnutrition.
• At the point of hospital discharge, the admission was for an acute medical illness.
• Has low maximum handgrip strength.
• Estimated life expectancy of more than 12 months.
• Community ambulant.
• No other chronic disease.
• Able to communicate and follow instructions.
• Able to consume food and beverages orally.
• Willing to refrain from taking non-study oral nutritional supplements over the course of the study.
• Able and willing to follow study procedures.

Критерии исключения

• Index hospitalization admission was for a surgical procedure or a stroke/myocardial infarction.
• Diagnosed with type 1 or type 2 diabetes.
• Has an active infectious disease.
• Diagnosed with severe gastrointestinal disorders.
• With severe or unstable congestive heart failure.
• With chronic kidney disease stage 2 or higher, end-stage organ failure, or other pre-terminal condition.
• Has an active malignancy within the past five years or currently receiving treatment for malignancy.
• Has a severe or unstable musculoskeletal or neuromuscular disorder.
• Unable to perform a valid handgrip strength assessment.
• Any condition that makes the participant unsuitable for the study.
• Currently enrolled in another clinical study.
• Has an eating disorder, alcoholism or substance abuse.
• Has dementia, delirium, or a significant neurological or psychiatric disorder.
• Known allergy or intolerance to any ingredients of the study product.
• Continuous use of ONS for 14 days prior to the baseline visit.
• Has used herbal products, dietary supplements, or medications in the past 30 days that could affect body weight, appetite, or body composition.
• Presence of clinically significant ascites, pleural effusion, edema, or dehydration.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Таиланд · 7 центров

• King Chulalongkorn Memorial Hospital — Bangkok
• Phramongkutklao Hospital — Bangkok
• Siriraj Hospital — Bangkok
• Vajira Hospital — Bangkok
• Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
• Songklanagarind Hospital — Hat Yai
• Naresuan University Hospital — Phitsanulok

Идентификаторы

NCT: NCT07753239 · BL95

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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