UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Acronym	Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Scientific Title	Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Scientific Title:Acronym	Effects of Capsicum ingredient intake on energy metabolism and brown adipose tissue density
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine changes in resting energy consumption, brown adipose tissue density, visceral fat area, body composition, chill, and vigor/fatigue tiredness induced by Capsicum ingredient intake in middle and elderly men.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in resting energy rate and brown adipose tissue density after 6 weeks
Key secondary outcomes	1) Changing body composition (body temperature, fat area) 2) Oxygen consumption 3) Questionnaire on life style and actual feeling

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	Prevention
Type of intervention	Food
Interventions/Control_1	Healthy volunteers are given a Capsicum ingredient (9.0 mg/day) supplement every day for 6 weeks.
Interventions/Control_2	Healthy volunteers are given a placebo supplement every day for 6 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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male
Key inclusion criteria	1) Subjects who have will to follow the experimental design and get agreement on participation. 2) Subjects who can come to Tokyo Medical University where conduct examination. 3) Subjects who have a body mass index (BMI) of 23-28 kg/m2. 4) Subjects who can ingest a capsule.
Key exclusion criteria	1) Subjects who routinely intake nutritional foods and/or supplements such as catechin, sesamin, and capsaicin of which usefulness for energy metabolism have been reported. 2) Subjects who routinely take medicine such as coenzyme Q10 and adenosine triphosphate which have an effect on energy metabolism. 3) Subjects who routinely intake nutritional foods and/or supplements such as monoglucosyl hesperidin and shogaol of which usefulness for maintenance of body temperature have been reported. 4) Subjects with extremely higher than 100 micromol/L of total-hemoglobin concentration in tissue in the supraclavicular region which is index of brown adipose tissue density whose increase energy metabolism. 5) Subjects who have been diagnosed with obesity. 6) Subjects with a disease causing hyperthyroidism. 7) Subjects who are judge as unsuitable for the study by the investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Hamaoka
Organization	Tokyo Medical University
Division name	Department of Sports Medicine for Health Promotion
Zip code	160-8402
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL	03-3351-6141
Email	hamaoka@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Sayuri Middle name Last name Fuse
Organization	Tokyo Medical University
Division name	Department of Sports Medicine for Health Promotion
Zip code	160-8402
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL	03-3351-6141
Homepage URL
Email	fuse@tokyo-med.ac.jp

Sponsor
Institute	Department of Sports Medicine for Health Promotion, Tokyo Medical University
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
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	Center for Research Administration and Innovation, Tokyo Medical University
Address	6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo Japan
Tel	03-3342-6111
Email	IRB@tokyo-med.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	東京医科大学（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 25 Day
Date of IRB	2019 Year 04 Month 05 Day
Anticipated trial start date	2019 Year 11 Month 17 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The title at Ethical appraisal is different from the registration title of this time due to patent applications.

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2020 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043426