- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857463
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei City, Taiwan
- Taipei Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
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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
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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
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No Intervention: Healthy control
No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood biochemical value
Time Frame: at the start of the experiment and at the 6th and 12th week
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blood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc
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at the start of the experiment and at the 6th and 12th week
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Blood pressure
Time Frame: at the start of the experiment and at the 6th and 12th week
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measure systolic and diastolic blood pressure.
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at the start of the experiment and at the 6th and 12th week
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Body position measurement
Time Frame: at the start of the experiment and at the 6th and 12th week
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height, weight, waist-to-hip ratio, body mass index, etc.
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at the start of the experiment and at the 6th and 12th week
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Body composition
Time Frame: at the start of the experiment and at the 6th and 12th week
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Use a body fat machine to measure muscle mass, fat mass and water content.
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at the start of the experiment and at the 6th and 12th week
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Muscle strength test
Time Frame: at the start of the experiment and at the 6th and 12th week
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measure 6m walking speed, grip strength measurement, etc.
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at the start of the experiment and at the 6th and 12th week
|
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
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at the start of the experiment and at the 6th and 12th week
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Quality of life and health status
Time Frame: at the start of the experiment and at the 6th and 12th week
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Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status
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at the start of the experiment and at the 6th and 12th week
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202011065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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