A single-blind, placebo controlled, randomized trial to evaluate the efficacy of protein fortified food in rehabilitation patients.
- Conditions
- Patients in recovery phase rehabilitation hospital
- Registration Number
- JPRN-UMIN000019360
- Lead Sponsor
- Tokyo Bay Rehabilitation Hospital
- Brief Summary
The cross sectional areas of fat infiltration muscles in the thigh decreased in the HP group more than pracebo group. Otherwise, there was no difference in the total cross-sectional area of the thigh muscles between two groups. In the HP group, resting metabolism rate was increased and body fat rate was decreased significantly after intervention. Blood 25 (OH) D was significantly higher in the HP group after intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skeletal muscle mass (BIA, thigh muscle area by Computed tomography) after 16 weeks intervention
- Secondary Outcome Measures
Name Time Method 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)