Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061411) titled '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' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - National Institute of Biomedical Innovation, National Institutes of Biomedical Innovation
Condition:
Condition - Sarcopnia
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 65
years-old
= 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 Size - 60
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070259
Disclaimer: Curated by HT Syndication.
