UMIN-CTR Clinical Trial

Basic information
Public title	Effects of functional dietary ingredients on post-meal bodily sensation
Acronym	Effects of functional dietary ingredients on post-meal bodily sensation
Scientific Title	Effects of functional dietary ingredients on post-meal bodily sensation
Scientific Title:Acronym	Effects of functional dietary ingredients on post-meal bodily sensation
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine the effect on the bodily sensation after a single intake of meal containing functional dietary ingredient for healthy Japanese men and women aged 20 to 60 years using a questionnaire.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective evaluation of the bodily sensation using questionnaire (frequency and intensity of bodily sensation, and their cumulative value), physical condition changes after meals, vital signs,BMI,adverse events
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take test food A once on the day of the test.
Interventions/Control_2	Take test food B once on the day of the test.
Interventions/Control_3	Take test food placebo once on the day of the test.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1.Japanese male and female aged 20 to 60 years of aged at the time of the informed consent. 2.Subject who meets the human rights protection viewpoint and selection criteria, does not violate the exclusion criteria, and can comply with the management items during the test period. 3.BMI within 20.2kg/m2 to 27.2 kg/m2 for males and 18.5kg/m2 to 25.2kg/m2 for females. 4.Non-smoker 5. Subject who receives a sufficient explanation of the purpose and contents of the research, has the consent ability, and has a good understanding, voluntarily volunteer to participate in the research and has agreed in writing to participate in the research.
Key exclusion criteria	1.Subject who has a weight fluctuation of more than +-10kg within one year. 2.Subject who has experienced chest pain or abnormal pulse at rest. 3.Subject who frequently experience shortness of breath, dizziness, and loss of consciousness. 4.A family member who has died suddenly for unknown reasons. 5.Subject who has been diagnosed as having problems with the legs. 6.Subject who is treating rheumatism. 7.Subject who is taking medication or under medical treatment because of some serious illness. 8.Subject with a history of knee surgery or disease, or who regularly use of cane. 9.Subject with a history of allergies to drug, food, test food ingredients (milk protein, etc.) 10.Subject with a history of drug dependence or alcohol dependence. 11.Subject who has or had suspected of disorder with mental(such as depression) or sleep (such as insomnia and sleep apnea syndrome). 12.Subject who has irregular work rhythms such as working at night. 13.Subject who works in factories, construction, construction sites, etc. and engage in manual labor that overuses their bodies. 14.Subject who has extremely irregular lifestyle such as eating and sleeping. 15.Subject who has an unbalanced diet.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naohisa Middle name Last name Nosaka
Organization	The Nisshin OilliO Group, Ltd
Division name	Central Research Laboratory
Zip code	235-8558
Address	1 Shinmori-cho, Isogo-ku, Yokohama-shi, Kanagawa
TEL	045-757-5461
Email	n-nosaka@nisshin-oillio.com

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	The Nisshin OilliO Group, 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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.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	2020 Year 02 Month 04 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	2019 Year 12 Month 13 Day
Date of IRB	2019 Year 12 Month 13 Day
Anticipated trial start date	2020 Year 02 Month 07 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
Date trial data considered complete	2020 Year 05 Month 14 Day
Date analysis concluded

Other

Other related information

(Exclusion criteria continued) 16.Subject who has onset or history of serious disease (diseases on brain, liver (hepatitis), kidney, heart, immune system, thyroid, adrenal, and other metabolic organs, dysorder on glucose or lipid metabolism (diabetes or dyslipidemia), and cancer (malignant tumor)). 17.Subject who is taking health foods, supplements, or drugs that may affect fatigue reduction. 18.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 19.Subject who drawed 200mL or more (within the past 1 months from the day of the consent acquisition) or 400mL or more of blood (within the past 3 months from the day of the consent acquisition). 20.Subject who is planning to donate blood or receive vaccinations, or who wish to donate or vaccinate during the test period. 21.Subject who is pregnancy, lactation, or wishs to become pregnant during the study period. 22.Subject who can't keep the daily records. 23.Subject who is considered as an inappropriate by the medical doctor.

Management information
Registered date	2020 Year 02 Month 04 Day
Last modified on	2021 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044898