UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of an amino acid-containing drink on sarcopenia.
Title of the study (Brief title)	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	Katsuaki Namba
Organization	House Foods Corp.
Division name	Research & Development Institute
Address	1-4, Takanodai, Yotsukaido, Chiba, Japan
TEL	043-237-5211
Email	k-namba@housefood.co.jp

Public contact
Name of contact person	Chika Takeyama
Organization	House Foods Group Inc.
Division name	Central research & Development institute
Address	1-4, Takanodai, Yotsukaido, Chiba, Japan
TEL	043-237-5211
Homepage URL
Email	c-takeyama@housefoods.co.jp

Sponsor
Institute	House Foods Corp.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021195