UMIN-CTR Clinical Trial

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
Institute	Otsuma Women's University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043031