UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062126 |
|---|---|
| Receipt number | R000071066 |
| Scientific Title | Effects of test food intake on physical function and muscle strength in middle-aged and older adults: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/02 19:04:52 |
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Basic information
Public title
Effects of test food intake on physical function and muscle strength in middle-aged and older adults: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effects of test food intake on physical function and muscle strength in middle-aged and older adults
Scientific Title
Effects of test food intake on physical function and muscle strength in middle-aged and older adults: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effects of test food intake on physical function and muscle strength in middle-aged and older adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 16-week intake of test food containing the active ingredient on physical function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function (walking speed [6-meter walk test] and handgrip strength); between-group comparison at 16 weeks
Key secondary outcomes
1) Aging-related markers in immune cells; oxidative stress-related markers in T cells; high-sensitivity C-reactive protein (hs-CRP); Olink Target 48
2) Body composition (muscle mass measured by InBody770; bone mineral density measured by VENUS evo), muscle quality (phase angle and extracellular water ratio [ECW/TBW] measured by InBody770), muscle strength (knee extension strength), physical function (chair stand test [CS-30] and Timed Up & Go test)
3) Subjective assessment questionnaires (POMS2, Anti-Aging QOL Common Questionnaire, SCD-Q, and skin-related assessments using visual analog scales (VAS))
4) cold-like symptoms questionnaire
5) Physical function (walking speed and handgrip strength): between-group comparison at 8 weeks; within-group comparison before and after intervention; and change from baseline (delta 8-week value: 8-week value - screening value; delta 16-week value: 16-week value - screening value)
6) Comprehensive gene expression analysis in peripheral blood mononuclear cells (PBMCs) using single-cell RNA sequencing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food containing the active ingredient (high dose) for 16 weeks
Interventions/Control_2
Daily intake of test food containing the active ingredient (low dose) for 16 weeks
Interventions/Control_3
Daily intake of placebo (test food without the active ingredient) for 16 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women from 50 to 74 years old.
2) Individuals who subjectively feel that their physical fitness has declined compared with the past.
3) Individuals who have not engaged in regular exercise (at least 2 times per week and at least 30 minutes per session) for at least 1 year.
4) Individuals who have received a full explanation of the study objectives and procedures, have the capacity to provide informed consent, fully understand the study, voluntarily agree to participate, and have provided written informed consent.
Key exclusion criteria
1) Individuals with serious diseases such as diabetes, renal, hepatic, or cardiovascular diseases; thyroid or adrenal disorders; or other metabolic diseases, or those currently undergoing treatment for these conditions.
2) Individuals with chronic diseases who regularly use medications that may affect study outcomes.
3) Individuals who plan to start regular exercise (at least 2 times per week and at least 30 minutes per session) during the study period.
4) Individuals who have engaged in regular exercise (at least 2 times per week and at least 30 minutes per session) within the past 3 months.
5) Individuals who are unable to refrain from consuming supplements or health foods that may affect physical function or muscle strength during the study period.
6) Individuals who are unable to refrain from consuming foods rich in lactic acid bacteria, bifidobacteria, oligosaccharides, or live microorganisms during the study period.
7) Individuals who are expected to require regular medical visits or use of prescribed medications each year due to pollinosis or allergic rhinitis.
8) Individuals with implanted medical devices such as pacemakers or implantable cardioverter-defibrillators, or with metal implants in the body.
9) Individuals with allergies to medications or study food-related products.
10) Individuals with gastrointestinal diseases or a history of gastrointestinal surgery that may affect digestion or absorption (excluding appendicitis).
11) Individuals with a body mass index (BMI) of 30 or higher.
12) Night shift workers or individuals engaged in late-night work.
13) Individuals with a current or past history of drug or alcohol dependence.
14) Individuals currently participating in, or planning to participate in, other clinical studies involving the ingestion of foods, use of medications, or application of cosmetics or pharmaceuticals.
Due to character limitations, part of the exclusion criteria is presented in the "Other relevant information" section.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anela Building 8F, 3-3-3 Higashinihonbashi Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management Department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2026 | Year | 07 | Month | 08 | 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 | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to character limitations, additional exclusion criteria are listed below.
15) Individuals with excessive alcohol consumption (equivalent to more than approximately 60 g of pure alcohol per day).
16) Individuals who are unable to abstain from alcohol from 2 days prior to screening or other examination days.
17) Individuals judged by the principal investigator to be unsuitable for participation based on clinical test results at screening.
18) Individuals who have donated more than 200 mL of blood within 1 month prior to screening, or more than 400 mL (including component donation) within 3 months prior to screening.
19) Individuals with psychiatric disorders such as depression.
20) Individuals who are unable to appropriately perform assessments such as walking tests, chair stand tests, or handgrip strength measurements (e.g., requiring a cane, having difficulty with normal walking, experiencing severe pain, having undergone joint replacement surgery, or having hand injuries).
21) Individuals who smoke 21 or more cigarettes per day.
22) Individuals who have taken antibiotics within 1 month prior to screening.
23) Individuals who are otherwise judged by the principal investigator to be unsuitable for participation in the study.
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071066
