UMIN-CTR Clinical Trial

Basic information
Public title	Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Acronym	Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Scientific Title	Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Scientific Title:Acronym	Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of subject food intake for 8 consecutive weeks on the subjective evaluation of fatigue, vitality, and sleep, using placebo as a control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	POMS2 T-score and OSA-MA at before, 4 and 8 weeks
Key secondary outcomes	SF36 at before, 4 and 8 weeks and flulike symptoms score during intake period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food daily intake, for 8 weeks
Interventions/Control_2	Intake of placebo daily intake, for 8 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Men and women between 20 and 64 years of age. (2) Subjects who feel fatigued and less active (3) Subjects with poor sleep quality
Key exclusion criteria	(1) Subjects who regularly use health foods containing the ingredients involved in the test food (2) Subjects engaged in actions/drugs or health food use to improve fatigue, stress, or sleep. (3) Subjects with a disease undergoing treatment or with a disease determined to be in need of treatment. (4) Subjects who have, have been diagnosed with, or are strongly suspected of having a sleep-related illness. (5) Subjects with a previous diagnosis of chronic fatigue syndrome (6) Subjects who are being treated for or have a history of mental illness, or are suspected to be suffering from one. (7) Seriously ill subjects and subjects with a history of serious illness (8) Subjects with irregular working days (holidays) (9) Subjects whose lives will become irregular more than once during the research period due to day/night shift work or night work, or who are engaged in physical labor such as heavy lifting. (10) Subjects with major life changes planned during the study period. (11) Subjects who have allergic diseases and are constantly taking therapeutic medication. (12) Subjects with diarrhea (13) Subjects with less than 3 bowel movements per week. (14) Subjects who are pregnant or lactating and who plan to become pregnant or breastfeeding during the study period. (15) Subjects at risk of developing allergies in connection with the study. (16) Subjects whose physical measurements, physical examination values, and clinical examination values at the pre-examination are significantly outside the reference range.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name To
Organization	Kenkoukazoku Co., Ltd.
Division name	None
Zip code	892-0848
Address	10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL	099-223-5211
Email	yasushi.nakasone@kenkoukazoku.co.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Nakasone
Organization	Kenkoukazoku Co., Ltd.
Division name	None
Zip code	892-0848
Address	10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL	099-223-5211
Homepage URL
Email	yasushi.nakasone@kenkoukazoku.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Kenkoukazoku 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 12 Month 18 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	2020 Year 08 Month 20 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 09 Month 11 Day
Last follow-up date	2020 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 10 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047653