NCT05682781已完成不适用
Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Change in body weight
研究概览
简要总结
Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. The objective of this prospective, multicenter, randomized controlled, open-label, parallel-design study is to determine the effects of an oral nutritional supplement with dietary counseling on body weight, in comparison with dietary counseling alone, in community dwelling older adults at risk of malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant aged ≥60 years at risk of undernutrition.
- •Community-dweller.
- •Participant is community ambulant.
- •Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry.
- •Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation.
- •Participant is able to communicate and follow instructions.
- •Participant is able to consume food and beverages orally.
- •Participant is willing to refrain from taking non-study oral nutritional supplements.
- •Participant is able and willing to follow study procedures and record data in diary and complete forms or assessments as needed.
排除标准
- •Participant diagnosed with type 1 or type 2 diabetes.
- •Participant has active infectious disease.
- •Participant has been diagnosed with severe gastrointestinal disorders.
- •Participant has been diagnosed with advanced renal disease or end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the baseline visit.
- •Participant has active malignancy within the last five years, or is in current treatment for malignancy.
- •Participant has any 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.
- •Participant has disorder or other conditions, that may interfere with study product consumption or compliance with study protocol procedures.
- •Participant has been diagnosed or known to be allergic or intolerant to milk products.
- •Participant has continuous oral nutritional supplement usage for 30 days prior to the baseline visit.
- •Participant has been taking herbals, dietary supplements, or medications during the past 30 days prior to the baseline visit that could profoundly affect body weight or appetite.
- •Participant has clinically significant ascites, pleural effusion, edema, or dehydration
结局指标
主要结局
Change in body weight
时间窗: Baseline to 60 days
Measured in kg
次要结局
- Mid-upper arm circumference(Baseline, Study Day 30 and Study Day 60)
- Energy intake(Baseline, Study Day 30 and Study Day 60)
- Body mass index (BMI)(Baseline, Study Day 30 and Study Day 60)
- Nutrient intake(Baseline, Study Day 30 and Study Day 60)
- Malnutrition risk(Baseline, Study Day 30 and Study Day 60)
- Change in body weight(Baseline and Study Day 30)
研究者
研究点 (4)
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