"Impact of cost-effective, nutritionally optimized supplement on body composition and functional measures: A multicentric randomized trial among older adults at risk of malnutrition (I-CARE Study)"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Hand grip strength (kG)
研究概览
简要总结
Background: There has been drastic change in the structure of the population with tripling of the population 60 years and above. One of the hidden problems among elderly is the growing prevalence of malnutrition and sarcopenia.
Objectives Phase 1: To develop nutritional supplement that is acceptable and palatable to the elderly Indian population and Phase 2: To compare the effect of 6-month nutritional supplementation and nutritional education with nutritional education alone on body composition and functional measures among elderly Indians at risk of malnutrition/or malnourished.
Methods: Phase 1: A nutritional supplement in the form of a nutri snacks/ ladoo will be developed. It will be administered to total of number of 50 Elderly. Each participant will consume the supplement every day for 15 days. Following analysis of the data, the supplement will be suitably modified and prepared for the trial phase- phase 2. Phase 2: Elderly participants aged 60 years and above will be recruited from proposed centers and screened using the mini nutritional assessment scale. Participants identified as being at risk for malnutrition/or malnourished will be recruited. A randomized open-labelled trial will be performed for 180 days (6 months).
Expected outcome: The study will result in the creation of a cost-effective, appetizing, and easy-to consume supplemental product that meets the unique dietary requirements of the elderly population. This will enable policymakers at a national level to target the important problems of malnourishment and sarcopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •elderly participants at risk of malnourishment.
排除标准
- •Participants with known medical conditions leading to weight loss.
- •Individuals with active cancer currently undergoing therapy.
- •Participants with altered estimated Glomerular Filtration Rate (eGFR).
- •Individuals involved in any ongoing studies involving supplementation or interventions that could influence the outcomes of this study.
结局指标
主要结局
Hand grip strength (kG)
时间窗: Baseline and post intervention follow up at 6 months
次要结局
- Functional measures including muscle strength and physical performance(Baseline and post intervention follow up at 6 months)
研究者
Dr Sucharita S
St Johns Medical College