UMIN-CTR Clinical Trial

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

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Basic information

Public title

The effect of regular intake of Oral Nutritional Supplements on nutritional status.

Acronym

The effect of regular intake of ONS on nutritional status.

Scientific Title

The effect of regular intake of Oral Nutritional Supplements on nutritional status.

Scientific Title:Acronym

The effect of regular intake of ONS on nutritional status.

Region

Japan


Condition

Condition

Elderly persons

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

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

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Take ONS twice a day for 12 weeks.

Interventions/Control_2

No intervention

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Sachie
Middle name
Last name Ikeda

Organization

Kamakura Rehabilitation St. Therese Hospital

Division name

Community comprehensive care promotion center

Zip code

248-0033

Address

1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan

TEL

0467-32-4125

Email

sachie-ikeda@st-therese.jp


Public contact

Name of contact person

1st name Sachie
Middle name
Last name Ikeda

Organization

Kamakura Rehabilitation St. Therese Hospital

Division name

Community comprehensive care promotion center

Zip code

248-0033

Address

1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan

TEL

0467-32-4125

Homepage URL


Email

sachie-ikeda@st-therese.jp


Sponsor or person

Institute

Kamakura Rehabilitation St. Therese Hospital

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethics committee of Kamakura Rehabilitation St. Therese Hospital

Address

1-2-1 Koshigoe, Kamakura, Kanagawa 248-0033, Japan

Tel

0467-32-4125

Email

s-ikeda@st-therese.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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))


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

18

Results

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.

Results date posted

2021 Year 03 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 06 Month 28 Day

Date of IRB

2019 Year 06 Month 28 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 06 Month 25 Day

Date of closure to data entry

2020 Year 09 Month 25 Day

Date trial data considered complete

2020 Year 10 Month 27 Day

Date analysis concluded

2021 Year 01 Month 21 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 02 Day

Last modified on

2021 Year 03 Month 01 Day



Link to view the page

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