UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043993 |
|---|---|
| Receipt number | R000050199 |
| Scientific Title | Effects of functional dietary ingredients on post-meal bodily sensation |
| Date of disclosure of the study information | 2021/04/21 |
| Last modified on | 2022/04/21 15:18:30 |
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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
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
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
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050199
