UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034047
Receipt number R000038810
Scientific Title A questionnaire research on the food function
Date of disclosure of the study information 2018/09/07
Last modified on 2022/05/01 17:01:38

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A questionnaire research on the food function

Acronym

Research on the food function

Scientific Title

A questionnaire research on the food function

Scientific Title:Acronym

Research on the food function

Region

Japan


Condition

Condition

Heathy adults with normal food habit

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the sustaining effect of satiety between pancakes made with barley flour mix or wheat flour mix.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Satiety index calculated by Visual Analog Scale (VAS)

Key secondary outcomes

Calorie intake estimated by weight


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

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Pancake made with wheat flour mix
Backed with blended wheat flour mix (100g), whole egg (50g), and milk (50ml)
Wash out period; 1 weeks after the first test

Interventions/Control_2

Pancake made with barley flour mix
Backed with blended barley flour mix (100g), whole egg (50g), and milk (50ml)
Wash out period; 1 weeks after the first 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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adult men and women: above 20 years old and less than 59 years old at the date of informed consent signature.

Key exclusion criteria

1) The person who suffered from cardiovascular disease, liver disease, kidney disease, digestive organ disease, respiratory disease, diabetes mellitus, or person with those past histories
2) The person who have a history of malignant disease or who are undergoing treatment for chronic diseases
3) The person who are taking a medication
4) The person with a history of drug or food allergy
5) .The person who uses dietary fiber rich supplement (containing seaweed, konjac, psyllium) or whole grain foods (whole grain wheat, brown rice, rye, barley) daily.
6) Pregnant person, person with the intention of the pregnancy during the study time, the person whom I am nursing
7) The person with smoking habbit
8) Person participating in an examination to apply a clinical study now or a history of the participation within one month
9) The person with drug dependency or abuse or the existing above medical history
10) The person whose stool frequency: is not more than 5 days in a week.
11) Others. the person who judged an examination responsibility doctor to be inappropriate as a subject

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Seiichiro
Middle name
Last name Aoe

Organization

Otsuma Women's University

Division name

Faculty of Home Economics Department Food Science

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

+81-3-5275-6048

Email

s-aoe@otsuma.ac.jp


Public contact

Name of contact person

1st name Seiichiro
Middle name
Last name Aoe

Organization

Otsuma Women's University

Division name

Faculty of Home Economics Department Food Science

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

+81-3-5275-6048

Homepage URL


Email

s-aoe@otsuma.ac.jp


Sponsor or person

Institute

Otsuma Women's University, Faculty of Home Economics, Department of Food Science

Institute

Department

Personal name



Funding Source

Organization

Showa Sangyo Co., Ltd.
Research Center for Fundamental Technologies

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Otsuma Women's University Life Science Research Ethics Committee

Address

12 Sanban-cho, Chiyoda-ku, Tokyo, Japan

Tel

03-5275-6408

Email

kenkyu.s@ml.otsuma.ac.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

大妻女子大学(東京都)/Otsuma Women’s university (Tokyo)
昭和産業株式会社/ Showa Sangyo Co., Ltd. (Chiba)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 07 Day


Related information

URL releasing protocol

http://www.jasso.or.jp/contents/magazine/manual/26-3.html

Publication of results

Unpublished


Result

URL related to results and publications

http://www.jasso.or.jp/contents/magazine/manual/26-3.html

Number of participants that the trial has enrolled

25

Results

Baked barley pancakes (BP) significantly reduced the VAS scores of hunger and prospective food consumption, and increased fullness and satiety before lunch compared to wheat pancakes (WP) (p<0.05). Energy intake at lunch subsequent to BP consumption was significantly lower than WP (p<0.05).

Results date posted

2022 Year 05 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 11 Month 01 Day

Baseline Characteristics

healthy Japanese men and women

Participant flow

The recruitment of subjects was conducted by in-house recruitment of male and female employees of Showa Sangyo Co., Ltd.

Adverse events

None

Outcome measures

Energy intake from the lunch was measured from a self-served plate of food minus left over waste. Subjects perception scores on hunger, fullness, prospective food consumption, and satiety were assessed using a visual analogue scale (VAS) before and after the breakfast and lunch.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 24 Day

Date of IRB

2018 Year 05 Month 15 Day

Anticipated trial start date

2018 Year 09 Month 07 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 04 Month 30 Day

Date trial data considered complete

2019 Year 04 Month 30 Day

Date analysis concluded

2019 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 09 Month 05 Day

Last modified on

2022 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name