The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly

Taipei Medical University

Status: Completed

Conditions: Malnutrition Elderly

Treatments: Other: Nutritional education; Other: Nutritional supplement drink

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04857463

N202011065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 3 patient groups, including a placebo group

Nutritional supplement drink

Experimental group

Description:

Nutritional supplement, this group receives a nutritional supplement for a period of 12 weeks.

Treatment:

Other: Nutritional supplement drink

Nutritional education

Placebo Comparator group

Description:

Qualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education

Treatment:

Other: Nutritional education

Healthy control

No Intervention group

Description:

No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done.