The Effect of 12 Weeks of Nutritional Supplementation on Nutritional Intake and Status in Older Outpatients With Malnutrition Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Changes in carbohydrate intake in grams
研究概览
简要总结
The primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin D, and Vitamin B12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care.
The secondary outcomes are body weight, nutritional status, body composition, physical performance, vitamin D level, and nonelective hospitalization
The Study Hypothesize:
The hypothesize that outpatients who receive nutrient-dense drinks (NDD) will have increased body weight, better nutritional status, better body composition, higher vitamin D level, better physical performance and reduced non-elective hospitalization than those receiving standard care after 12 weeks of intervention.
详细描述
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Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel
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Treatment 1: nutrient-dense drinks on top of standard care
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Treatment 2: standard care only (reference)
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Location and time study: Geriatric outpatient clinic and internal medicine outpatient clinic in Cipto Mangunkusumo National Hospital Jakarta. The study will be conducted on July 2022 to October 2023.
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Study subject: elderly outpatients (aged 60 years old or more) who visit outpatient clinics will be screened for their eligibility as participants of this study.
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Sample Size: sample size for each group is 41 participants per group (for two groups a total of 82 participants). To anticipate a dropout of 20% a minimum of 98 participants (rounded to 100 participants in total) is the minimum sample size of our study.
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Data collection : Energy and nutrient intake, particularly protein calcium, vitamin D, and vitamin B12, Nutritional status based on full form Mini Nutritional Assessment, Vitamin D level, lean body mass (using Bioelectrical Impedance Analysis), physical performance will be measured by Shor Physical Performance Battery, handgrip strength, medical history, data on the demographic status and clinical data will be retrieved from the medical record and the attending physicians, body weight and anthropometric measurements, intervention: Nutrient Dense-Drink + Standard Care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessment will be performed by blinded raters.
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
- •older patients (60-years or older)
- •Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)
排除标准
- •Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
- •Unwillingness to participate
结局指标
主要结局
Changes in carbohydrate intake in grams
时间窗: at baseline and week 12
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in Fat intake in grams
时间窗: at baseline and week 12
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes of Energy in Kilocalories
时间窗: at baseline and week 12
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in Protein intake in grams
时间窗: at baseline and week 12
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in micronutrients intake in micrograms
时间窗: at baseline and week 12
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
次要结局
- Changes of Vitamin D level(Screening (Week 0) and week 12)
- Changes of Short Physical Performance Battery Score(Screening (Week 0) and week 12)
- Changes of Mini Nutritional Status Score(at screening (Week 0) and week 12)
- Changes of Body Weight(Screening (week 0) and Week 12)
- Changes to Chair Stand Test(Screening (Week 0) and week 12)
- Changes of Skeletal Muscle Mass(Screening (Week 0) and week 12)
- Changes of Handgrip Strength(Screening (Week 0) and week 12)
- Number of the Participants with Rehospitalization(3 months (12 weeks))
- Gait Speed(Screening (Week 0) and week 12)
研究者
Siti Setiati
Professor of Geriatric Medicine
Indonesia University