UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062315 |
|---|---|
| Receipt number | R000071242 |
| Scientific Title | Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults |
| Date of disclosure of the study information | 2026/07/25 |
| Last modified on | 2026/07/23 14:22:42 |
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Basic information
Public title
Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults
Acronym
Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults
Scientific Title
Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults
Scientific Title:Acronym
Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore the effects of demographic characteristics, lifestyle, and dietary habits on changes in body composition during a 12-week dietary intervention involving foods containing GABA, isoflavones, and Beta-cryptoxanthin, using an open-label, uncontrolled trial.
Basic objectives2
Others
Basic objectives -Others
To explore the relationship between demographic characteristics, lifestyle, and dietary habits and body composition through a cross-sectional analysis using pre-intervention data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (muscle mass)
Key secondary outcomes
Body Composition (Body Weight, Body Fat Percentage, BMI, Lean Body Mass, Skeletal Muscle Mass, Body Fat Mass, Skeletal Muscle Index (SMI), Body Water Balance (ECW/TBW), Total Body Water, Intracellular Water, Extracellular Water, Protein Mass, Mineral Mass, Body Fat Mass, Somatic Cell Mass, Bone Mineral Mass, Impedance, Reactance, Phase Angle, Skeletal Muscle Percentage, Lean Body Index, Body Fat Index) , Physical Fitness Tests (walking speed, 5-repetition STS, grip strength), Skin Examination (skin thickness, stratum corneum condition), Vital Signs (blood pressure and pulse rate upon arrival), Serum Bone Metabolism Markers (TRACP-5b, total PINP), Skeletal Muscle Markers (procollagen III peptide [P-III-P], IGF-1, Myostatin), serum metabolome, urinary metabolome, gut microbiota, stool collection questionnaire, frailty-related questionnaires (Basic Checklist, WHO-5, Brief Job Stress Questionnaire Domain B, Skindex-16, PSQI-2, Sleep Restfulness Questionnaire, Skin Questionnaire), blood tests (complete blood count, liver function, kidney function, blood lipids, blood glucose, nutritional status), and bone metabolism-related gene expression
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Foods containing GABA, isoflavones, and Beta-cryptoxanthin
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
| 55 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who agree to participate in this study with a written informed consent
Japanese men and women aged 55 to 64 at the time of the screening examination (preliminary examination)
Those who are aware of muscle weakness
Those with a relatively low skeletal muscle index
Key exclusion criteria
Those receiving nutritional guidance as part of medical treatment.
Those receiving continuous medication affecting bone metabolism.
Those diagnosed with diabetes mellitus.
Those with an HbA1c level >= 6.5% at screening.
Those diagnosed with dyslipidemia.
Those with LDL-C levels >= 180 mg/dL at screening.
Those with eGFR levels < 45 mL/min/1.73m^2 at screening.
Those with BMI value >= 35 kg/m^2 at screening.
Those with severe cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory, or notifiable infectious diseases.
Those using medications/supplements affecting blood pressure (e.g., monoglucosyl hesperidin, lactotripeptides).
Those routinely using health foods/supplements with GABA.
Those routinely using health foods/supplements with beta-cryptoxanthin.
Those routinely using health foods/supplements with soy isoflavones.
Those whose soy isoflavone intake may exceed the safe limit (70-75mg/day) due to the test food.
Those with major abnormalities in blood pressure, anthropometry, or blood tests.
Those with potential allergies to drugs or foods (especially soy).
Those unable to continuously consume the test food due to allergic reactions etc.
Those with a history of feeling unwell or sick due to blood collection.
Those with implanted metal devices (pacemakers, ICDs, artificial joints, plates, etc.).
Those with metal implants in the lumbar spine or hip joints.
Those expecting major daily lifestyle changes during the study.
Perimenopausal women experiencing significant physical changes.
Heavy smokers, heavy drinkers, or those with extremely irregular lifestyles.
Those who donated 400mL blood within 16 (women)/12 (men) weeks, 200mL within 4 weeks, or components within 2 weeks before intake.
Those in other clinical trials, observational studies, or home-use tests from 4 weeks before screening to completion.
Any others deemed ineligible by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-0832
Address
45-7, Nishi-nopporo, Ebetsu, Hokkaido, 069-0832, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
Institute of Science Tokyo
KOSE Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 25 | 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
| 2026 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071242
