Clinical trial NCT04857463: The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
Official title: The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition Elderly
Keywords: Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Meiji Co., Ltd.
First posted: 2021-04-23
Enrollment: 161
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a clustered, randomized, parallel, multicenter clinical trial.
Primary purpose: OTHER

Brief summary: Past studies have pointed out that adequate intake of calories and protein in the elderly can deferred sarcopenia and debilitating conditions. Therefore, this study intends to use oral nutrition as a way of nutritional supplements, without affecting the subjects' normal meal intake, and supplements with snacks It is expected that there will be benefits in protein and muscle synthesis.

However, the palatability of oral nutritional products will affect the effectiveness of nutritional supplements. Therefore, this test provides nutrients that are easy for the subjects to ingest with a variety of flavors, in order to achieve the test calories and protein needs.

In order to investigate and compare the nutritional status, serum zinc and vitamin D status in healthy (MUST score 0) elderly and at risk of malnutrition elderly, we recruited healthy elderlies in the nursing home.

Detailed description: In this study, subjects were randomly assigned. Through a multi-center research method, a total of 100 eligible subjects were recruited, and their consent was obtained and a subject consent form was signed. The subjects were divided into two groups according to the way of nutritional intervention, including nutritional education (NE) and nutritional supplement drink (NSD), with 50 people in each group. The NE group is given regular nutrition education by qualified clinical nutritionists to ensure the effectiveness of nutrition education. In the NSD group, in addition to nutrition and health education, daily oral supplements (Meiji Mei Balance, Meiji Co., Ltd., Tokyo, Japan) are provided daily, and snacks are supplemented between lunch and dinner and before bedtime, 2 per day. bottle. The two groups were divided into groups by lottery, and the intervention period was 12 weeks. During the intervention period, blood will be drawn at the beginning, 6th, and 12th week of the case, and blood pressure, body position, body composition and muscle strength will be measured, and dietary intake will be assessed. At the same time, a quality of life survey will also be conducted. survey, QoL survey.

Moreover, we recruited 50 healthy elderly to investigate and compare the nutritional status, serum zinc and vitamin D status in healthy elderly and at risk of malnutrition elderly. This group was considered as a control group and we didn't do any intervention after blood collection and physical measurements.

Eligibility criteria: Inclusion Criteria:

1. age \>65 years old (regardless of gender)
2. Malnutrition risk judgment: Subjects were assessed as moderate and high malnutrition risk with the malnutrition risk screening tool MUST (Malnutrition Universal Screening Tool)

Exclusion Criteria:

1. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.

Primary outcomes:
measure: Blood biochemical value
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Blood pressure
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Body position measurement
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Body composition
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Muscle strength test
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Diet pattern
timeFrame: at the start of the experiment and at the 6th and 12th week
measure: Quality of life and health status
timeFrame: at the start of the experiment and at the 6th and 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: