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Nutritional intervention study to maintain and improve ADL in older adults with diabetes

Development of nutritional therapy that contributes to the maintenance and improvement of ADL in older adults with diabetes - Protein enrichment intervention trial for older adults with diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051128
Enrollment
50
Registered
2023-06-01
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Sarcopenia

Interventions

Implement nutritional dietary guidance on protein intake. Specifically, protein-enriched food (commercially available) will be provided, and the daily protein intake will be 1.5 g or more per 1 kg of

Sponsors

Kansai Electric Power Medical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Diabetic patients aged 65 and over (2) Subjects with decreased muscle mass or grip strength (SMI: men <7.0 kg/m^2, women <5.7 kg/m^2, grip strength: men <28 kg, women <18 kg) (3) Subjects whose protein intake is less than 1.2g/kg/day (4) Patients who are outpatients (5) Persons who can write dietary records

Exclusion criteria

Exclusion criteria: (1) Subjects with obvious dementia or mental illness (2) Persons using steroids (3) Patients with liver disorder with Child Pugh classification of 7 points or more, or renal dysfunction with eGFR less than 45 (4) Heart failure with limitation of physical activity (New York Heart Association classification of heart failure II or higher) (5) Subjects who have a history of gastrointestinal reconstructive surgery (6) Subjects who have incurable cancer (7) Those who have a cardiac pacemaker or an implanted cardioverter-defibrillator (8) Subjects with motor paralysis in the extremities due to central neuromuscular disease (9) Persons who are judged to be inappropriate for this clinical study by the research implementation supervisor or co-investigator

Design outcomes

Primary

MeasureTime frame
Changes in muscle mass, grip strength, and breakfast protein intake ratio over 6 months.

Secondary

MeasureTime frame
Changes in stratum corneum water content, physical activity, and blood biochemical tests (HbA1c, creatinine, estimated glomerular filtration rate) over a 6 months.

Countries

Japan

Contacts

Public ContactShota Moyama

Kansai Electric Power Medical Research Institute Department of Metabolism and Nutrition, Diabetes Research Center

shota0531@gmail.com+81-6-6458-5821

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026