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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition Elderly
• Intervention / Treatment: Other: Nutritional supplement drink; Other: Nutritional education

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplement drink; Nutritional supplement, this group receives a nutritional supplement for a period of 12 weeks.	Other: Nutritional supplement drink; At the intervention period (0th to 12th week of the experiment), In addition to nutrition and health education, subjects were provided with 2 bottles of commercially available oral nutritional supplements (Meiji Mei Balance, Meiji Co., Ltd., Tokyo, Japan) every day, between lunch and dinner and before bedtime.
Placebo Comparator: Nutritional education; Qualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education	Other: Nutritional education; At the intervention period (0th to 12th week of the experiment) , subjects will be given regular nutrition education by a qualified clinical dietitian to ensure the effectiveness of nutrition education, in order for the nutrition education group to benefit from participating in this trial, the subjects will also be provided with the same nutritional products after the trial
No Intervention: Healthy control; No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biochemical value	blood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc	at the start of the experiment and at the 6th and 12th week
Blood pressure	measure systolic and diastolic blood pressure.	at the start of the experiment and at the 6th and 12th week
Body position measurement	height, weight, waist-to-hip ratio, body mass index, etc.	at the start of the experiment and at the 6th and 12th week
Body composition	Use a body fat machine to measure muscle mass, fat mass and water content.	at the start of the experiment and at the 6th and 12th week
Muscle strength test	measure 6m walking speed, grip strength measurement, etc.	at the start of the experiment and at the 6th and 12th week
Diet pattern	Evaluate the 24-hour recall method and Three-day dietary record	at the start of the experiment and at the 6th and 12th week
Quality of life and health status	Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status	at the start of the experiment and at the 6th and 12th week

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Meiji Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: N202011065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No