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临床试验/NCT03648580
NCT03648580已完成不适用

Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Mini Nutritional Assessment short-form (MNA®-SF) score

研究概览

简要总结

Background: As the aging of the population aggravating, the ratio of the elderly in empty nest family has reached 50%, particularly in big and medium size cities, it is as high as 70%. The elderly in those families where no child living inside, elderly living alone, including an individual living alone or living with spouse are known as empty nester. The diversity of food consumption of empty nester is always poor, with single and simple meals, especially for the consumption of "core food" (fish, meat, egg, milk, vegetables and fruits), and the quantity and variety of consumption is very limited, which make the elderly be prone to be deficient of high quality protein and micronutrient. In 2005, the World Health Organization (WHO) brought up a new concept for the universally exiting problem of vitamin and trace elements intake deficiency among people, namely Hidden Hunger. With age increasing, multiple causes such as single eating pattern, empty nest lifestyle and chronic diseases lead to long term intake deficiency of protein and micronutrient of the elderly, which will further result in various symptoms of nutritional deficiency. Therefore, it is particularly important for the empty nester to have sufficient energy, high quality protein and multiple micronutrients to prevent hidden hunger and sarcopenia, thus avoiding the health problem and life quality decreasing caused by them.

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
None

盲法说明

It's an open study. The number of protocol evaluable subjects for each group that complete the study and comply well with study protocol is planned to be 30.

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •the one who is or is between 65 to 85 years old, male or female;
  • •the one with nutritional risk according to MNA-Short Form evaluation (score less than12);
  • •the one who has low skeletal muscle mass (with bioelectrical impedance analysis report indicating that the skeletal muscle mass is less than 90% of the normal level) and/or the one who has at least 1 type of the micronutrient deficiency symptom (part A < 40 or part A < 85 in the hidden hungry evaluation questionnaire)

排除标准

  • •long-term bedridden or the one has difficult in taking food orally;
  • •Liver failure in recent one year;
  • •Renal insufficiency (serum creatinine is more than 2 times of normal value)
  • •the one who is allergic to or not applicable to the component in oral dietary supplement;
  • •the one with parkinsonism, epilepsy and other nervous system disorders;
  • •malignant tumor patients with chemotherapy and chemotherapy;
  • •irritable bowel disease and other chronic wasting diseases.
  • •Taking multi-vitamin&mineral supplements or protein or other oral nutritional supplements

研究组 & 干预措施

Intervention group

Experimental

Give the verbal nutrition education and supply Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks

干预措施: Ensure Complete powder (Dietary Supplement)

Intervention group

Experimental

Give the verbal nutrition education and supply Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks

干预措施: verbal nutrition education (Other)

Control group

Other

just give the verbal nutrition education.

干预措施: verbal nutrition education (Other)

结局指标

主要结局

Mini Nutritional Assessment short-form (MNA®-SF) score

时间窗: 12 weeks

MNA®-SF is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The Screening score(max. 14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished".

次要结局

  • Muscle mass--The change of percentage of skeletal muscle mass(12 weeks)
  • Muscle strength--The change of Calf circumference(12 weeks)
  • Dietary Nutrients(12 weeks)
  • The change of DETERMINE score(12 weeks)
  • The change of BMI(12 weeks)
  • Muscle strength--6 meters gait speed(12 weeks)
  • Questionnaire--Healthy lifestyle questionnaire(12 weeks)
  • Questionnaire--Self-satisfaction questionnaire(12 weeks)
  • Muscle strength--The change of Grip strength(12 weeks)
  • Hidden Hunger Assessment Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting Zhao

Technologist-in-charge

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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