A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.

A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients. - A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019360

Enrollment

Registered

2015-10-20

Start date

2015-10-20

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

Patients in recovery phase rehabilitation hospital

Interventions

Protein(10g/pack) and Vitamin D(20ug/pack) fortified food (2pack/day, 16weeks) Placebo(Protein 0g, Vitamin D 0ug) food (2pack/day, 16weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 40 or older 2. FIM locomotion subscore is 4 or less, social interaction subscore is 6 or over and comprehension and expression is 5 or over 3. Within two weeks after admission 4. Patients who can ride normal wheelchair

Exclusion criteria

Exclusion criteria: 1. Impossible to get informed concent by cognitive deficit 2. Impossible to be treated with exercise therapy due to complication or previous disease 3. Impossible to swallow experimental food 4. Patients who receive parenteral or enteral Nutrition 5.eGFR score is less than 60 mL/min/1.73m2 6. peel of citrus species supplementation 7. Vitamin D supplementation or medicine 8. Protein or amino acid supplementation 9. Patients who are judged inappropriate for the study by the physician

Design outcomes

Primary

Measure	Time frame
Skeletal muscle mass (BIA, thigh muscle area by Computed tomography) after 16 weeks intervention	—

Secondary

Measure	Time frame
Muscle strength (handgrip, lower limb), ADL (FIM, mBI), Physical activity (walking test, timed up & go test, chair-stand test), Nutritional index(alb, pre-Alb, IGF-1, DHEA-s, free-teststerone, 25(OH)D, PTH, Ca), length of hospital stay, discharge disposition (home/not home)	—

Countries

Japan

Contacts

Public ContactKaoru Honaga

Tokyo Bay Rehabilitation Hospital Rehabilitation Department

rh_fortune@hotmail.com047-453-9000

Outcome results

None listed

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