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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04857463
Enrollment
161
Registered
2021-04-23
Start date
2021-11-03
Completion date
2023-12-01
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Elderly

Keywords

Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk

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.

Interventions

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.

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

Sponsors

Meiji Co., Ltd.
CollaboratorINDUSTRY
Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

This study was a clustered, randomized, parallel, multicenter clinical trial.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood biochemical valueat the start of the experiment and at the 6th and 12th weekblood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc
Blood pressureat the start of the experiment and at the 6th and 12th weekmeasure systolic and diastolic blood pressure.
Body position measurementat the start of the experiment and at the 6th and 12th weekheight, weight, waist-to-hip ratio, body mass index, etc.
Body compositionat the start of the experiment and at the 6th and 12th weekUse a body fat machine to measure muscle mass, fat mass and water content.
Muscle strength testat the start of the experiment and at the 6th and 12th weekmeasure 6m walking speed, grip strength measurement, etc.
Diet patternat the start of the experiment and at the 6th and 12th weekEvaluate the 24-hour recall method and Three-day dietary record
Quality of life and health statusat the start of the experiment and at the 6th and 12th weekUse the quality of life questionnaire (SF-36) to evaluate the quality of life and health status

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026