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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

NCT07309120

Low Muscle Mass Low Muscle Strength Low Physical Function

COMPLETED NA

Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly

NCT06991855

Sarcopenia Sarcopenia in Elderly

RECRUITING NA

Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults

NCT05828134

Muscle Loss Muscle Weakness

COMPLETED NA

Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia

NCT04516421

Sarcopenia

UNKNOWN NA

Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults

NCT05243472

Sarcopenia Muscle Loss Malnutrition

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition Elderly

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutritional supplement drink

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

Group Type EXPERIMENTAL

Nutritional supplement drink

Intervention Type OTHER

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.

Nutritional education

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

Group Type PLACEBO_COMPARATOR

Nutritional education

Intervention Type OTHER

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

Healthy control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)