UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053751 |
|---|---|
| Receipt number | R000061184 |
| Scientific Title | Randomized parallel group comparative study on improving nutritional status with oral nutritional supplements in community-dwelling elderly |
| Date of disclosure of the study information | 2024/03/09 |
| Last modified on | 2024/03/01 17:07:53 |
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Basic information
Public title
Study on improving nutritional status using oral nutritional supplements for community-dwelling elderly
Acronym
Study on improving nutritional status using oral nutritional supplements for community-dwelling elderly
Scientific Title
Randomized parallel group comparative study on improving nutritional status with oral nutritional supplements in community-dwelling elderly
Scientific Title:Acronym
Randomized parallel group comparative study on improving nutritional status with oral nutritional supplements in community-dwelling elderly
Region
| Japan |
Condition
Condition
Under-nutritional condition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of improving nutritional status by taking for 16 weeks the nutritional supplement, fortified with eicosapentaenoic acid (EPA), branched-chain amino acids (BCAA), and inulin, targeted at community-dwelling elderly people who tend to be malnourished and attend day service facilities that provide functional training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
BMI, Body composition, calf circumference, grip strength, total protein, albumin, total lymphocyte count, Prognostic Nutritional Index, prealbumin, total cholesterol, high-sensitivity CRP, blood EPA concentration, blood BCAA concentration , intestinal microbiota, MNA-SF score, Functional Independence Measure (motor subscales)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking orally one pack of nutritional supplement (200 kcal) per day for 16 weeks in addition to regular meals
Interventions/Control_2
No test food intake
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Community dwelling elderly aged 65 or more
2. Those who regularly visit the facility (at least once a week) and undergo functional training.
3. Persons with a Mini Nutritional Assessment-Short Form (MNA-SF) score of 11 or less
Key exclusion criteria
1. Persons with a BMI of 23 kg/m2 or more
2. Persons with moderate or higher dementia
3. Persons who are depressed
4. Persons who are allergic to cow's milk or soybeans
5. Persons who have difficulty in swallowing and in ingesting the test food
6. Persons who have been instructed by a doctor or dietitian to restrict their intake of energy or protein
7. Persons who are taking medicines or supplements which main ingredients are EPA or BCAA
8. Persons who have collected or plan to collect a cumulative total of 400 ml or more of blood within 12 weeks before the start date of taking the test food.
9. Persons who are participating in other clinical trials or who plan to participate in other clinical trials during the study period
10.Persons who are judged to be unsuitable as subjects by the study director due to subject background, lifestyle, etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Chikao |
| Middle name | |
| Last name | Miki |
Organization
Hekisuikai
Division name
Yashio Station Square Home Care Clinic
Zip code
340-0822
Address
6-9-7, Ose, Yashio-City, Saitama-Pref, Japan
TEL
048-954-5508
c.miki@hekisuikai-cl.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsubara |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL
046-252-3057
Homepage URL
ta-matsubara@morinagamilk.co.jp
Sponsor or person
Institute
Yashio Station Square Home Care Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@jccr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061184
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
