Malnutrition ElderlyNCT04857463
The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
A study testing Nutritional supplement drink and Nutritional education in people with Malnutrition Elderly, run by Taipei Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition Elderly
- What is being tested?
- Nutritional supplement drink and Nutritional education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Nov 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 1. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malnutrition Elderly
- Being tested
- Nutritional supplement drink, Nutritional education
- Keywords
- Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplement drinkOther
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 educationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement drink | Experimental | Nutritional supplement, this group receives a nutritional supplement for a period of 12 weeks. Receives: Other: Nutritional supplement drink |
| Nutritional education | Placebo comparator | Qualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education Receives: Other: Nutritional education |
| Healthy control | No intervention | No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the start of the experiment and at the 6th and 12th week
Blood pressure
measure systolic and diastolic blood pressure.
Measured: 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.
Measured: 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.
Measured: at the start of the experiment and at the 6th and 12th week
Muscle strength test
measure 6m walking speed, grip strength measurement, etc.
Measured: 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
Measured: 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
Measured: at the start of the experiment and at the 6th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start3 Nov 2021
- Primary completion30 May 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition ElderlyStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a clustered, randomized, parallel, multicenter clinical trial.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Meiji Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857463
- Sponsor's protocol ID
- N202011065
- Status last verified
- Jan 2023
- First submitted
- 20 Apr 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly
- ClinicalTrials.gov ID
- NCT04857463
- Acronym / sponsor ID
- N202011065
- Conditions
- Malnutrition Elderly
- Keywords
- Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Meiji Co., Ltd.
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study was a clustered, randomized, parallel, multicenter clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement drink | Experimental | Other: Nutritional supplement drinkNutritional supplement, this group receives a nutritional supplement for a period of 12 weeks. |
| Nutritional education | Placebo comparator | Other: Nutritional educationQualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education |
| Healthy control | No intervention | –No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 1. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplement drinkAt 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. | Other | Nutritional supplement drink |
| Nutritional educationAt 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 | Other | Nutritional education |
Primary outcome
Blood biochemical value
Time frame: at the start of the experiment and at the 6th and 12th week
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
Time frame: at the start of the experiment and at the 6th and 12th week
measure systolic and diastolic blood pressure.
Body position measurement
Time frame: at the start of the experiment and at the 6th and 12th week
height, weight, waist-to-hip ratio, body mass index, etc.
Body composition
Time frame: at the start of the experiment and at the 6th and 12th week
Use a body fat machine to measure muscle mass, fat mass and water content.
Muscle strength test
Time frame: at the start of the experiment and at the 6th and 12th week
measure 6m walking speed, grip strength measurement, etc.
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
Quality of life and health status
Time frame: at the start of the experiment and at the 6th and 12th week
Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplement drink and Nutritional education in people with Malnutrition Elderly, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biochemical value (time frame: at the start of the experiment and at the 6th and 12th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.