Unique ID issued by UMIN | UMIN000037901 |
---|---|
Receipt number | R000043203 |
Scientific Title | The effect of regular intake of Oral Nutritional Supplements on nutritional status. |
Date of disclosure of the study information | 2019/09/02 |
Last modified on | 2021/03/01 14:24:59 |
The effect of regular intake of Oral Nutritional Supplements on nutritional status.
The effect of regular intake of ONS on nutritional status.
The effect of regular intake of Oral Nutritional Supplements on nutritional status.
The effect of regular intake of ONS on nutritional status.
Japan |
Elderly persons
Adult |
Others
NO
To evaluate the effect of regular intake of ONS on nutritional status by means of comparing intake with non-intake of ONS in elderly persons who have attended nursing facilities in an open trial (20 in each group).
Efficacy
Exploratory
Pragmatic
Phase II
body weight, body mass index(BMI), muscle mass, skeletal muscle mass, limb skeletal muscle mass, skeletal muscle mass index(SMI), segmental muscle mass, body fat mass,segmental body fat mass, body fat percentage, serum albumin, serum transthyretin (serum prealbumin), geriatric nutritional risk index (GNRI), grip strength, 10m walking speed, timed up and go test (TUG), knee extensor strength, one-leg standing test, forward reach test, mini nutritional assessment-short form (MNA-SF), basic checklist for care prevention
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Food |
Take ONS twice a day for 12 weeks.
No intervention
65 | years-old | <= |
Not applicable |
Male and Female
1) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
2) Elderly men and women over 65 years old who use nursing facilities and living in their house, at a screening test.
3) Subjects who are less than 11 of MNA-SF points, at a screening test.
1) Subjects who is being serious or progressive diseases.
2) Subjects in BMI of more than 25.0 kg/m2 .
3) Depressed patients
4) Dementia patients
5) Severe liver disease patients
6) Subjects who receive dietetic treatment of energy or protein restrictions.
7) Subjects who implant a pacemaker.
8) Subjects who have difficulty in taking test food.
9) Subjects who have milk or soybean allergy.
10) Participation in other clinical studies during the last one month.
11) Subjects who are judged unsuitable for this study by the principal investigator or the research physician.
40
1st name | Sachie |
Middle name | |
Last name | Ikeda |
Kamakura Rehabilitation St. Therese Hospital
Community comprehensive care promotion center
248-0033
1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan
0467-32-4125
sachie-ikeda@st-therese.jp
1st name | Sachie |
Middle name | |
Last name | Ikeda |
Kamakura Rehabilitation St. Therese Hospital
Community comprehensive care promotion center
248-0033
1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan
0467-32-4125
sachie-ikeda@st-therese.jp
Kamakura Rehabilitation St. Therese Hospital
Meiji Co., Ltd.
Profit organization
Japan
The ethics committee of Kamakura Rehabilitation St. Therese Hospital
1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan
0467-32-4125
s-ikeda@st-therese.jp
NO
鎌倉リハビリテーション聖テレジア病院(神奈川県)
(Kamakura Rehabilitation St. Therese Hospital(Kanagawa))
2019 | Year | 09 | Month | 02 | Day |
Unpublished
18
The levels of blood transthyretin and the changes from base line in BMI, although both of which were used as nutritional status indicators, were significantly large in elderly patients with probable malnutrition who had been cared at home and provided regularly ONS as meals.
In addition, the ONS intake made significantly increases of the change in BMI and of the amount of skeletal muscle mass among the patients who were 75 years of age or older.
2021 | Year | 03 | Month | 01 | Day |
Completed
2019 | Year | 06 | Month | 28 | Day |
2019 | Year | 06 | Month | 28 | Day |
2019 | Year | 10 | Month | 01 | Day |
2020 | Year | 06 | Month | 25 | Day |
2020 | Year | 09 | Month | 25 | Day |
2020 | Year | 10 | Month | 27 | Day |
2021 | Year | 01 | Month | 21 | Day |
2019 | Year | 09 | Month | 02 | Day |
2021 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043203
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |