UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of increasing basal metabolic rate by ingestion of botanical ingredient-containing foods.
Title of the study (Brief title)	A study to evaluate the effect of increasing basal metabolic rate by ingestion of botanical ingredient-containing foods.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of increasing basal metabolic rate by ingestion of botanical ingredient-containing foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Basal metabolic rate, 4, 8 and 12 weeks after investigation.
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	Botanical ingredient-containing foods, 12 Weeks.
Interventions/Control_2	Botanical ingredient-non-containing foods, 12 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 years of age or older 2) 25 kg/m2 <= BMI < 30 kg/m2 3) With no treatment. 4) Submitting the written informed consent before this study.
Key exclusion criteria	1) With exercise or sports, strength training more than 3 times a week. 2) Under losing body weight. 3) Female with unstable estradiol cycle. 4) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food. 5) Subjects who are; (a) With present heart disorder, liver disorder, or kidney disorder, (b) With previous or present cardiac disorder, (c) With diabetes mellitus, or (d) With allergy to the study foods. 6) Female in pregnancy, lactation and scheduled pregnancy period. 7) Investigator's judgment for other reason.
Target sample size	90

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Hidenori Obata
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Homepage URL
Email	Hidenori_Obata@suntory.co.jp

Sponsor
Institute	Suntory Business Expert Limited
Institute
Department

Funding Source
Organization	Suntory Beverage & Food Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026359