UMIN-CTR Clinical Trial

Basic information
Public title	Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine
Acronym	Safety and efficacy evaluation of drink with a plant-derived product and carnosine
Scientific Title	Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine
Scientific Title:Acronym	Safety and efficacy evaluation of drink with a plant-derived product and carnosine
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Test to evaluate safety and efficacy of 8-week-drinking with a plant-derived product and carnosine
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Number of adverse effects Stress reaction
Key secondary outcomes	Number of adverse events Proteins and chemicals in blood Intestinal bacterial flora analysis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	One drink with plant-derived product and carnosine every day for eight weeks
Interventions/Control_2	One drink without plant-derived product and carnosine every day for eight weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 20 to less than 65 years old. 2) Top 60 people detected as high stressor 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1) Subjects who take continuous medical treatment. 2) Subjects who have systolic blood pressure less than 90 mmHg. 3) Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman. 4) Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study. 5) Male subjects who donated 400 mL of blood within the last three months prior to the current study. 6) Female subjects who donated 400 mL of blood within the last four months prior to the current study. 7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Subjects who are participating in other clinical studies, or who finished clinical study within three months. 10) Subjects who are contracting heart disease, liver disease, kidney disease and digestive disease. 11) Subjects who have contracted a disease in circulatory organs. 12) Subjects who have allergic reaction to drug medicine and food. 13) Subjects who drink alcohol or smoke a lot. 14) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift. 15) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. 16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Norihito Middle name Last name Murayama
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL	050-3182-0588
Email	Norihito_Murayama@suntory.co.jp

Public contact
Name of contact person	1st name Jiro Middle name Last name Takano
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0598
Homepage URL
Email	Jiro_Takano@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clini
Address	2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 26 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	60
Results	Unpublished
Results date posted	2021 Year 03 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unpublished
Participant flow	Unpublished
Adverse events	Unpublished
Outcome measures	Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 18 Day
Date of IRB	2015 Year 08 Month 18 Day
Anticipated trial start date	2015 Year 08 Month 26 Day
Last follow-up date	2015 Year 11 Month 13 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 12 Month 04 Day
Date analysis concluded	2018 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date	2015 Year 08 Month 24 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021727