A monitoring study to investigate the effects of soft meals on weight gain and grip strength in elderly volunteers
- Conditions
- Elderly individuals aged 65 years old or older
- Registration Number
- JPRN-UMIN000029873
- Lead Sponsor
- InCROM Inc
- Brief Summary
Among 30 subjects, a total of 28 finished the trial, The change in body weight from the start of the study to the end was -0.45 +/- 0.75 kg (Mean+/-SD, the same hereinafter), 95% confidence interval (CI) on both sides was [-0.74, -0.15], P=0.0041, showing a significant decrease. Through the analysis of the individual weight change, body weight increased in only 6 subjects, equaled in 3 subjects, and decreased in 19 subjects. More than 1 kg of body weight decreased in 6 subjects, whereas that increased in none. The maximum change in body weight was 0.8 kg, and minimum -2.7 kg. The change in BMI was -0.12 +/- 0.30, and the 95% CI on both sides was [-0.24, -0.01], P=0.0384, showing a significant decrease. No significant changes in grip strength, serum total protein, or albumin were observed. The change in grip strength was 0.1 +/- 1.6 kg, and 95% CI on both sides was [-0.5, 0.8], P=0.6458. The change in serum total protein was -0.07 +/- 0.27 g/dL, 95% CI on both sides was [-0.17, 0.04], P=0.1872. The change in albumin was -0.02 +/- 0.18 g/dL, 95% CI on both sides was [-0.09, 0.05], P=0.6131. No significant adverse events were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
Diabetic patients History of previous or present illness that interferes with ethical conduct of the research as determined by the investigator, e.g., hepatic or renal disorder; gastrointestinal, cardiovascular, respiratory, endocrine, metabolic, nervous, or psychological disease Those with extremely lowered appetite Those who possibly have allergy to test diets History of previous or present drug or alcohol dependence Those who live in a welfare facility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method