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Clinical Trials/NCT04857463
NCT04857463
Completed
N/A

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

Taipei Medical University1 site in 1 country161 target enrollmentNovember 3, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malnutrition Elderly
Sponsor
Taipei Medical University
Enrollment
161
Locations
1
Primary Endpoint
Body composition
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2021
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \>65 years old (regardless of gender)
  • 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

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

Outcomes

Primary Outcomes

Body composition

Time Frame: at the start of the experiment and at the 6th and 12th week

Use a body fat machine to measure muscle mass, fat mass and water content.

Muscle strength test

Time Frame: at the start of the experiment and at the 6th and 12th week

measure 6m walking speed, grip strength measurement, etc.

Blood biochemical value

Time Frame: at the start of the experiment and at the 6th and 12th week

blood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc

Blood pressure

Time Frame: at the start of the experiment and at the 6th and 12th week

measure systolic and diastolic blood pressure.

Body position measurement

Time Frame: at the start of the experiment and at the 6th and 12th week

height, weight, waist-to-hip ratio, body mass index, etc.

Diet pattern

Time Frame: at the start of the experiment and at the 6th and 12th week

Evaluate the 24-hour recall method and Three-day dietary record

Quality of life and health status

Time Frame: at the start of the experiment and at the 6th and 12th week

Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status

Study Sites (1)

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