Sarcopnia
Conditions
Interventions
An intervention group that supplemented their regular diet with approximately 300 kcal/day of energy as a supplement.
Control group continuing their normal diet
Sponsors
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fat-free mass from baseline to 12 weeks after the dietary intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYoichi Hatamoto
National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation Department of Nutrition and Metabolism
Outcome results
None listed