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临床试验/NCT03240952
NCT03240952已完成不适用

Establishing Reference Range for Community-dwelling Elderly Nutrition

Abbott Nutrition4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
4
主要终点
MUST

研究概览

简要总结

Elderly are at greater risk of dietary insufficiency due to age-related increases in nutrient requirements concomitant with a reduction in energy requirements, decreases in appetite and energy intake. Currently there is a gap in knowledge of the factors that are associated with malnutrition in the elderly in Singapore. In addition, there is no "reference" database on anthropometric measurements and biochemical indices for elderly with a range of nutrition status in Singapore. Thus, the objectives of this cross-sectional study are to examine factors influencing nutritional status and to determine the reference values for anthropometric and biochemical measurements related to nutritional status for community-dwelling elderly in Singapore.

详细描述

This is a cross-sectional study. Measurements will be taken at baseline for elderly with normal nutrition (n = 400) and elderly who are at risk of under nutrition (n = 800).. These measurements will be used to examine factors influencing nutritional status and to create a "reference" database for anthropometric and biochemical measurements related to nutritional status for use in clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

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.

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.

结局指标

主要结局

MUST

时间窗: Baseline

Malnutrition risk using Malnutrition Universal Screening Tool

次要结局

  • Body weight, fat mass, fat free mass(Baseline)
  • Pre-albumin(Baseline)
  • Albumin and total protein(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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