UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on Energy Metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
Scientific Title	A Study on the Effect of Food Containing Plant Extract on Energy Metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of food containing plant extract on energy metabolism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Energy metabolism
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Food containing plant extract, 8 weeks consumption
Interventions/Control_2	Food not containing plant extract, 8 weeks consumption
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	30 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	(1) Healthy males aged 30 to 39 years-old. (2) Subjects whose BMI are 20 or over and under 25. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who contract chronic disease and are under treatment. (2) Subjects who have a history of and/or contract serious diseases (eg, liver and kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (3) Subjects who are judged to correspond to diabetic type, have hypertension and/or have symptoms of anemia by the screening tests. (4) Subjects who have declared allergic reaction to ingredients of test foods. (5) Subjects who can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting energy metabolism during test periods. (6) Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or a habit of drinking not less than 5 days a week. (7) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (8) Subjects who can't stop drinking from 2 days before each measurement. (9) Subjects who have a habit of smoking. (10) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (11) Subjects who are judged as unsuitable for the current study by the investigator through the screening tests. (12) Subjects who are shiftworker and/or midnight-shift worker. (13) Subjects who have regular exercise not less than 2 days a week. (14) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (15) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical examination and treatment management family chief director
Zip code	108-0075
Address	1-2-70, Konan, Minato-ku, Tokyo
TEL	03-3452-3382
Email	satoru_suzuki@sempos.or.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7, Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., 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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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 05 Month 10 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041804
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/48050/835
Number of participants that the trial has enrolled	80
Results	Statistically significant difference was confirmed in the energy expenditure. Statistically significant difference was not confirmed in the respiratory quotient.
Results date posted	2020 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males aged 30 to 39 years old.
Participant flow	Enrolled(n=80) Completed(n=78) Analysed(n=61)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	Energy metabolism
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 05 Month 07 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 11 Day
Last follow-up date	2019 Year 08 Month 24 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 05 Month 09 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041804