UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018313
Receipt number R000021195
Scientific Title The effect of an amino acid-containing drink on sarcopenia.
Date of disclosure of the study information 2016/10/31
Last modified on 2019/02/06 16:48:34

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Basic information

Public title

The effect of an amino acid-containing drink on sarcopenia.

Acronym

The effect of an amino acid-containing drink on sarcopenia.

Scientific Title

The effect of an amino acid-containing drink on sarcopenia.

Scientific Title:Acronym

The effect of an amino acid-containing drink on sarcopenia.

Region

Japan


Condition

Condition

Sarcopenia

Classification by specialty

Geriatrics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of a leucine -containing drink on sarcopenia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Usual walking speed

Key secondary outcomes

grip strength


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Taking of Leucine-containing drink for three months

Interventions/Control_2

Nothing
three months

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects whose BMI values are between 15.0 kg/m2 and 18.5 kg/m2.
Male subjects whose grip strength values are less than 25.0 kg.
Female subjects whose grip strength values are less than 20.0 kg.

Key exclusion criteria

(1)Subjects who have allergy to gelatin or collagen.
(2)Subjects who take daily supplementation of collagen, amino acids or vitamin D.
(3) Subjects with hemiplegia caused by brain infarction.
(4)Subjects who can't understand the instructions because of dementia.
(5)Subjects who are diagnosed as Parkinson's disease.
(6)Subjects who exercise therapy cannot be applied to because of pain derived from joint disease.
(7)Subjects who are classified as Nursing Care Level 3 or above.
(8)Patients with renal or liver disorder.
(9)Patients with maple syrup urine disease.
(10)Subjects who are on medication for diabetes.
(11) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuaki Namba

Organization

House Foods Corp.

Division name

Research & Development Institute

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Email

k-namba@housefood.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chika Takeyama

Organization

House Foods Group Inc.

Division name

Central research & Development institute

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Homepage URL


Email

c-takeyama@housefoods.co.jp


Sponsor or person

Institute

House Foods Corp.

Institute

Department

Personal name



Funding Source

Organization

House Foods Corp.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Internet Infinity Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


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

2015 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 14 Day

Last modified on

2019 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021195


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name