UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a research food on total body water
Acronym	Effects of a research food on total body water
Scientific Title	Effects of a research food on total body water
Scientific Title:Acronym	Effects of a research food on total body water
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a research food on total body water.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total body water
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of the test food - single ingestion of the placebo food
Interventions/Control_2	Single ingestion of the placebo food - single ingestion of the test food
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Men and women aged 20 to 65 years at the time of obtaining consent. 2)BMI of 18.5 kg/m^2or more but less than 25.0 kg/m^2. 3)Those who have received sufficient explanation of the test, understand the contents, and can give written consent in person. 4) Those who have completed two doses of the new coronavirus vaccine.
Key exclusion criteria	1)Those who have current medical treatments, or who are planning some kind of treatment the test period. 2)Those who constantly use medicines that may affect test results.(diuretic, antidiuretic, etc.).Those who take health foods and supplements (oral rehydration solution, saw palmettoetc.) daily, and those who may take or take them during the test period. 3)Those who are scheduled to take medication or receive vaccinations between one week before the first test date and the second test date. 4)Those who may onset seasonal allergies such as hay fever and take medicines during test period. 5)Those who may change their lifestyle (night shift, long trip, etc.) during test period. 6)Heavy drinkers of alcohol. 7)Those who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc. 8)Individuals with probable seasonal allergy, such as pollinosis, during the test period. 9) Those who are pregnant, lactating, or intend to become pregnant during the study period. 10)Those with allergies to medicines or food. 11)Those who are currently participating in a clinical trial of another drug or health food, and plan to participate in another clinical trial within 4 weeks of the end of the trial, or after consenting to participate in the trial. 12)Patients who are judged to be inappropriate for participation in the study by the principal investigator or sub-investigator.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Kawama
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Email	t-kawama-jb@morinaga.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Morinaga
Organization	Morinaga & Co., Ltd.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-571-6140
Homepage URL
Email	m-morinaga-bj@morinaga.co.jp

Sponsor
Institute	Morinaga & Co., Ltd.
Institute
Department

Funding Source
Organization	Morinaga & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 10 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	Completed
Date of protocol fixation	2022 Year 01 Month 31 Day
Date of IRB	2022 Year 01 Month 31 Day
Anticipated trial start date	2022 Year 03 Month 17 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 02 Day
Last modified on	2022 Year 09 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053660