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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020779
Receipt No. R000023981
Scientific Title A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Date of disclosure of the study information 2016/02/01
Last modified on 2018/08/09

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Basic information
Public title A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Acronym A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Scientific Title A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Scientific Title:Acronym A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Region
Japan

Condition
Condition Open distal gastrectomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study whether preoperative administration of amino acids, cystine and theanine, accelerate recovery from postoperative reduction of activity amount.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Changes in amount of activity from 2 days before to 1 week after surgery measured using wristwatch-type motion logger.
Key secondary outcomes Hematological and blood biochemistry indices before and 1, 3, 7, 14days after surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing 700mg of cystine and 280mg of theanine once daily for 10 days from 2days before until 7days after surgery.
Interventions/Control_2 No ingestion of supplement instead of the cystine and theanine.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Received a written informed consent by patient's self-determination.
2.Scheduled to receive open distal gastrectomy.
3.From 20 to less than 80 years old.
4.No severe complication before surgery.
Key exclusion criteria 1.Phenyl ketonuria.
2.Active infection.
3.Poorly controlled hypertension.
4.Poorly controlled diabetes.
5.Clinically important cardiac disease.
6.Severe pulmonary disease(e.g. interstitial pneumonia, fibrosis, severe emphysema).
7.History of clinically important psychopathic disorder or central nervous system damage.
8.Continuous systemic administration(iv or po) of steroid.
9.Pregnancy, breast-feeding, possible pregnancy, and willing to be pregnant.
10.Particpation for other studies.
11.Impossible of oral ingestion.
12.Judged ineligible by the principal investigator of sub-investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center Sendai Open Hospital
Division name Director, GI Surgery
Zip code
Address 5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL 022-252-1111
Email tsuchiya@openhp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Tsuchiya
Organization Sendai City Medical Center Sendai Open Hospital
Division name Director, GI Surgery
Zip code
Address 5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL 022-252-1111
Homepage URL
Email tsuchiya@openhp.or.jp

Sponsor
Institute Sendai City Medical Center Sendai Open Hospital
Institute
Department

Funding Source
Organization Ajinomoto Co., Inc.
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
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 02 Month 01 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
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 Terminated
Date of protocol fixation
2016 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 28 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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