UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061411 |
|---|---|
| Receipt number | R000070259 |
| Scientific Title | Effects of an Energy-Supplemented Dietary Intervention under Free-Living Conditions on Body Composition and Physical Function in Community-Dwelling Older Adults with Sarcopenia: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/28 23:42:57 |
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Basic information
Public title
Effects of an Energy-Supplemented Dietary Intervention under Free-Living Conditions on Body Composition and Physical Function in Community-Dwelling Older Adults with Sarcopenia: A Pilot Randomized Controlled Trial
Acronym
Energy Supplementation for Sarcopenia in Older Adults Study
Scientific Title
Effects of an Energy-Supplemented Dietary Intervention under Free-Living Conditions on Body Composition and Physical Function in Community-Dwelling Older Adults with Sarcopenia: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
ENERGY-SARC Trial (Energy Supplementation for Sarcopenia Trial)
Region
| Japan |
Condition
Condition
Sarcopnia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate whether an increase in energy intake can be achieved and to examine the effects of energy intake exceeding estimated requirements on body weight, body composition (fat mass and fat-free mass), and physical function (sarcopenia-related indicators) in community-dwelling older adults with sarcopenia. Participants will be allocated to either a control group maintaining their usual diet or an intervention group receiving an additional energy supplement of approximately 300 kcal/day under free-living conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in fat-free mass from baseline to 12 weeks after the dietary intervention
Key secondary outcomes
1. Changes in body weight, appendicular skeletal muscle mass, fat mass, and physical function indicators from baseline to 12 weeks
2. Intervention adherence rate
3. Study completion rate
4. Incidence of adverse events
This study is conducted as a pilot trial. Estimates and 95% confidence intervals will be reported to obtain information on effect sizes and variability for the design of future trials.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
An intervention group that supplemented their regular diet with approximately 300 kcal/day of energy as a supplement.
Interventions/Control_2
Control group continuing their normal diet
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. Adults aged 65 years or older
2. Individuals who are able to provide written informed consent to participate in the study voluntarily
3. Individuals who are able to live independently in daily life, including walking and performing household activities without assistance
Key exclusion criteria
1. Individuals with severe obesity (BMI >= 27 kg/m2).
2. Individuals currently taking SGLT2 inhibitors.
3. Individuals who initiated treatment with diuretics, alpha-blockers, or beta-blockers within 4 weeks prior to providing informed consent.
4. Individuals with chronic or acute diseases, including malignant tumors, liver disease, kidney disease, HIV infection, or thyroid disorders. However, individuals with hypertension or diabetes mellitus that are well controlled with prescribed medication will not be excluded.
5. Individuals who are currently following a calorie-restricted diet as medical nutrition therapy.
6. Individuals with extremely irregular dietary habits.
7. Individuals with food allergies to any of the foods provided in the study.
8. Individuals who habitually consume excessive alcohol (>= 60 g of pure alcohol per day).
9. Individuals who are judged by the principal investigator or study investigators to be inappropriate for participation in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
566-0002
Address
Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan
TEL
06-6384-1120
yhatamoto@nibn.go.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation
Division name
Department of Nutrition and Metabolism
Zip code
566-0002
Address
Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan
TEL
06-6384-1120
Homepage URL
yhatamoto@nibn.go.jp
Sponsor or person
Institute
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation
Institute
Department
Personal name
Funding Source
Organization
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Medical Ethics Committee
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka, Japan
Tel
0928716631
yamatai0605@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
K26-04-001
Org. issuing International ID_1
Fukuoka University
Study ID_2
Org. issuing International ID_2
IND to MHLW
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070259
