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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039382
Receipt No. R000044898
Scientific Title Effects of functional dietary ingredients on post-meal bodily sensation
Date of disclosure of the study information 2020/02/04
Last modified on 2020/02/18

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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 No longer recruiting
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
Date trial data considered complete
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
2020 Year 02 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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