UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058980 |
|---|---|
| Receipt number | R000067452 |
| Scientific Title | A study on food diversity among the elderly and verification of the effectiveness of nutritional supplement drinks in improving vitamin intake |
| Date of disclosure of the study information | 2025/09/03 |
| Last modified on | 2025/09/03 17:51:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on food diversity among the elderly and verification of the effectiveness of nutritional supplement drinks in improving vitamin intake
Acronym
Dietary Surveys and Nutritional Supplement Drinks in the Elderly
Scientific Title
A study on food diversity among the elderly and verification of the effectiveness of nutritional supplement drinks in improving vitamin intake
Scientific Title:Acronym
Dietary Surveys and Nutritional Supplement Drinks in the Elderly
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As society ages, individual level disease prevention has become increasingly crucial. Specifically, preventing individuals from becoming bedridden and extending what is known as healthy life expectancy the period during which people remain active are essential goals. Diet is one of the simplest ways to maintain health in daily life. Notably, vitamin and mineral deficiencies are often observed in underweight individuals. Among young, underweight women, deficiencies in vitamins D and B12 are common, and similar risks are also a concern among the elderly. In Daito City, Osaka Prefecture, a regular activity called Genki de Masse Exercise is held, during which we assessed the dietary habits of its participants. By examining the current nutritional status of elderly participants, we aimed to improve the dietary habits of local residents. Additionally, we investigated the extent to which vitamin and mineral levels would increase after consuming commercially available vitamin supplements for seven days. Simultaneously, we sought to determine whether distributing such nutritional supplements could enhance the health of local residents in the future. Through this study, if we can evaluate the actual diversity of foods among the elderly and demonstrate the potential for improvement with nutritional supplements, it could provide local governments with insights for offering nutritional guidance or distributing supplements as interventions for residents, thereby contributing to the promotion of community health.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For participants in the Genki de Masse Taiso, we will conduct a food frequency survey , and collect information on height, weight, age, sex, weight six months ago, changes in appetite over the past two weeks, and underlying health conditions, in order to determine the prevalence of undernutrition within the group based on GLIM criteria. Next, for each sex, we will divide the participants into three groups underweight, normal weight, and obese and clarify the differences in food diversity among the groups.
Key secondary outcomes
Of those who responded to the questionnaire, approximately 20 people (up to a maximum of 30) who do not meet the exclusion criteria (listed separately) will have their blood drawn. Afterward, they will take Ikkyo Sensai Drink for 7 days, and their blood will be drawn again on the 7th day. Changes in blood concentrations of zinc, iron, vitamin B1 and B12, and folic acid before and after taking Ikkyo Sensai Drink will be analyzed separately by gender, using paired t-tests to compare the values before and after.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The study participants will be given a seven-day supply of nutritional drinks to take orally.
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are 65 years or older and can consent to taking the Ikkyu Chisai drink for 7 consecutive days,
those who have no abnormal test values related to diabetes, kidney disease, or liver disease,
those who can present their medication notebook (to confirm types, amounts, and duration of diabetes medication and antacids),
those with no food allergies,
those who are able to communicate their own intentions to others,
and those who can manage daily life independently.
Key exclusion criteria
People with poorly controlled diabetes (HbA1c > 7%), those with liver disease, kidney disease, or heart disorders, those with cancer, those taking supplements or health foods, and others deemed inappropriate by the principal investigator or co-investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
Department of Clinical Nutrition, Faculty of Medicine
Zip code
4701192
Address
1 98, Dengakugakubo, Kutsukake machi, Toyoake, Aichi
TEL
0562932329
katsumi.iizuka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
Department of Clinical Nutrition, Faculty of Medicine
Zip code
4701192
Address
1 98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562932329
Homepage URL
katsumi.iizuka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Fujita health university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1 98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.ac.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
| 2025 | Year | 09 | Month | 03 | 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
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067452
