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

Primary Purpose

Malnutrition Elderly

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nutritional supplement drink
Nutritional education
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition Elderly focused on measuring Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Nutritional supplement drink

Nutritional education

Healthy control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
Blood pressure
measure systolic and diastolic blood pressure.
Body position measurement
height, weight, waist-to-hip ratio, body mass index, etc.
Body composition
Use a body fat machine to measure muscle mass, fat mass and water content.
Muscle strength test
measure 6m walking speed, grip strength measurement, etc.
Diet pattern
Evaluate the 24-hour recall method and Three-day dietary record
Quality of life and health status
Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
September 7, 2023
Sponsor
Taipei Medical University
Collaborators
Meiji Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04857463
Brief Title
The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
Official Title
The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Meiji Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition Elderly
Keywords
Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional supplement drink
Arm Type
Experimental
Arm Description
Nutritional supplement, this group receives a nutritional supplement for a period of 12 weeks.
Arm Title
Nutritional education
Arm Type
Placebo Comparator
Arm Description
Qualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done.
Intervention Type
Other
Intervention Name(s)
Nutritional supplement drink
Intervention Description
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
Intervention Name(s)
Nutritional education
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood biochemical value
Description
blood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Blood pressure
Description
measure systolic and diastolic blood pressure.
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Body position measurement
Description
height, weight, waist-to-hip ratio, body mass index, etc.
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Body composition
Description
Use a body fat machine to measure muscle mass, fat mass and water content.
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Muscle strength test
Description
measure 6m walking speed, grip strength measurement, etc.
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Diet pattern
Description
Evaluate the 24-hour recall method and Three-day dietary record
Time Frame
at the start of the experiment and at the 6th and 12th week
Title
Quality of life and health status
Description
Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status
Time Frame
at the start of the experiment and at the 6th and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 1. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.
Facility Information:
Facility Name
Taipei Medical University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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

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