UMIN-CTR Clinical Trial

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

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

The Nisshin OilliO Group, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

02

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

02

Month

04

Day

Last modified on

2021

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044898