UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037729
Receipt number R000043031
Scientific Title Effects of repeated ingestion of plant-derived ingredient
Date of disclosure of the study information 2019/08/19
Last modified on 2021/07/07 12:02:01

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Basic information

Public title

Effects of repeated ingestion of plant-derived ingredient

Acronym

Effects of plant-derived ingredient

Scientific Title

Effects of repeated ingestion of plant-derived ingredient

Scientific Title:Acronym

Effects of plant-derived ingredient

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of repeated consumption of a plant-derived ingredient for 2 weeks on energy expenditure in young women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

energy expenditure

Key secondary outcomes

fat oxidation, RQ, LF, HL, LF/HF, entotic temperature


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

Treatment

Type of intervention

Food

Interventions/Control_1

Repeated intake control food, once in a day for 2 weeks, after wash out for 2 weeks, repeated intake test food, once in a day for 2 weeks.

Interventions/Control_2

Repeated intake test food, once in a day for 2 weeks, after wash out for 2 weeks, repeated intake control food, once in a day for 2 weeks.

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

29 years-old >=

Gender

Female

Key inclusion criteria

1. Healthy female adults aged from 20 y to 29 y
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study

Key exclusion criteria

1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
3. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
4. Subjects who are heavy alcohol addicts (more than 80 g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency.
5. Subjects who regularly take drugs, which would affect this study.
6. Subjects who regularly take foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
7. Subjects who participate in other clinical trials within 4 weeks prior to this study.
8. Subjects who are judged as unsuitable for this study by the principal investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Shoji

Organization

Otsuma Women's University

Division name

Department of Food Science, Faculty of Home Economics

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

0352756086

Email

shoji@otsuma.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Shoji

Organization

Otsuma Women's University

Division name

Department of Food Science, Faculty of Home Economics

Zip code

102-8357

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

TEL

0352756086

Homepage URL


Email

shoji@otsuma.ac.jp


Sponsor or person

Institute

Otsuma Women's University

Institute

Department

Personal name



Funding Source

Organization

Otsuma Women's University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical review committee of Otsuma Women's University

Address

12 Sanban-cho,Chiyoda-ku,Tokyo

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



Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 19 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

20

Results

A significant difference was observed in the primary endpoint

Results date posted

2021 Year 02 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy adults

Participant flow

20 participants completed and 19 subjects were incorporated into the analyses

Adverse events

No adverse effect reported

Outcome measures

resting energy expenditure

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 03 Month 15 Day

Date of IRB

2019 Year 03 Month 25 Day

Anticipated trial start date

2019 Year 03 Month 26 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 19 Day

Last modified on

2021 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043031


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name