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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of the test food once on the day of the test.
Interventions/Control_2	Ingestion of the placebo food once on the day of the test.
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	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 with BMI from 20.2 kg /m2 less than 27.2 kg /m2 for males and 18.5 kg /m2 less than 25.2 kg /m2 for females. 3.Non-smoker 4. Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria	1.Subject who is taking medication or under medical treatment due to serious illness. 2.Subject who has experienced chest pain or abnormal pulse at rest. 3.Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 4.Subject who is treating rheumatism. 5.Subject who frequently experiences shortness of breath, dizziness, and loss of consciousness. 6.Subject who has or had a history of drug allergies, food allergies, or allergies to raw materials for test foods (milk protein etc.). 7.Subject who has a family member who died suddenly of unknown causes. 8.Subject who has been diagnosed as having problems with the legs and hips. 9.Subject with knee surgery or disease, or those who use a cane on a daily basis. 10.Subject who has or had a history of either medicine or alcohol dependence syndrome. 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 extremely irregular lifestyle such as eating and sleeping. 13.Subject who has an unbalanced diet. 14.Subject who has irregular life rhythms such as working at night. 15.Subject who works in factories, construction sites, etc. and perform physical labor that overuses the body.
Target sample size	50

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

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Public relations department
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 Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
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	2021 Year 04 Month 21 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	50
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	2021 Year 04 Month 02 Day
Date of IRB	2021 Year 04 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 22 Day
Last follow-up date	2021 Year 07 Month 29 Day
Date of closure to data entry	2021 Year 07 Month 29 Day
Date trial data considered complete	2021 Year 09 Month 06 Day
Date analysis concluded	2022 Year 04 Month 21 Day

Other

Other related information

(Exclusion criteria continued) 16.Subject with a weight fluctuation of more than +-10 kg within a year. 17.Subject who is taking health foods, supplements, or medications 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 has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 20.Subject who plans or wish to donate blood or get vaccinated during the test period(Vaccination against COVID-19 is an exception). 21.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating. 22.Subject who can't keep the daily records. 23.Subject who is considered as an inappropriate candidate by the doctor in charge.

Management information
Registered date	2021 Year 04 Month 21 Day
Last modified on	2022 Year 04 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050199