A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 811
- 试验地点
- 8
- 主要终点
- Primary composite outcome consisting of change in body weight and unexpected hospital admission
研究概览
简要总结
The prevalence of malnutrition among the elderly in Asia is high. The objective of this randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of consuming an adult ONS plus dietary counseling (intervention group) for 180 days on nutritional status and unexpected hospital (re)admission, compared with a placebo supplement plus dietary counseling (control group).
详细描述
This randomized controlled trial will involve 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants will be randomized to intervention group vs. control group at the baseline visit at the clinical trial research unit where baseline measurements and baseline survey using the study specific questionnaires will be performed. Participants will be followed up prospectively at Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit). Repeated measures will be performed at the pre-defined time points. Intention-to-treat analysis comparing intervention group vs. control group will be performed to study the effect of ONS on primary composite outcome consisting of (i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The effect of ONS on nutritional status will be examined by comparing the biochemical and anthropometric measurements of intervention group vs. control group at Day 180. Other outcomes such as changes in functional assessment, nutritional knowledge levels, and quality of life will also be examined. There will be a follow up visit at Day 360.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study is double-blinded, i.e., during the study, neither the investigator(s), study and appropriate Abbott Nutrition staff, nor participants will be informed of the identity of any of the study products. Study center personnel will not analyze the contents of the study products or in any way seek to learn the identity of the study products. The investigator should ensure that if it becomes necessary, blinding is broken only in accordance with the protocol.
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant aged ≥65 years.
- •Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
- •Participant is being discharged home directly (applicable for hospital cohort).
- •Participant is community ambulant with or without aid.
- •Participant does not have any chronic disease(s) or has stable chronic disease(s) including hypertension, chronic obstructive pulmonary disease, and cardiovascular disease in the opinion of the Study Physician, at study entry
- •Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) and provided authorization prior to any participation in the study.
- •Participants will be able to communicate and follow instructions.
- •Participant is able to consume food and beverages orally.
- •Participant has been identified as at risk of undernutrition as defined by Malnutrition Universal Screening Tool.
- •Participant is willing to refrain from taking non-study oral nutritional supplements including protein powder over the entire course of the study.
- •Participant is able and willing to follow study procedures and record data in diary and complete any forms or assessments needed throughout the study, with or without the help of the caregivers.
排除标准
- •Participant has been diagnosed with dementia according to medical records.
- •Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
- •Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
- •Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
- •Participant has been diagnosed with end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the screening according to medical records.
- •Participant has malignancy according to medical records.
- •Participant has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
- •Participant is taking part in another study that has not been approved as a concomitant study by the study team.
- •Participant has been diagnosed or is known to be allergic or intolerant to milk products.
- •Participant has continuous ONS usage for 30 days prior to the screening.
结局指标
主要结局
Primary composite outcome consisting of change in body weight and unexpected hospital admission
时间窗: baseline to Day 180
(i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)
次要结局
- Fat mass and fat free mass(Baseline, 30 days, 90 days and 180 days])
- Length of stay of unexpected hospital admission(s)(90 days & 180 days)