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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016361
Receipt No. R000018998
Scientific Title Chronic effects of catechin ingestion on energy expenditure by brown adipose tissue in humans
Date of disclosure of the study information 2015/01/28
Last modified on 2015/01/28

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Basic information
Public title Chronic effects of catechin ingestion on energy expenditure by brown adipose tissue in humans
Acronym Brown adipose tissue and catechin
Scientific Title Chronic effects of catechin ingestion on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym Brown adipose tissue and catechin
Region
Japan

Condition
Condition Healthy male volunteers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the chronic effects of green tea catechins on energy expenditure and to analyze its relation to brown adipose tissue activity and adiposity in humans.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Whole body energy expenditure assessed from respiratory gas analysis
Key secondary outcomes Respiratory quotient,
Skin temperature
Body fat content

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Beverages containing 1080 mg catechins were given daily for 5 wk, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and after 2-h cold exposure.
Interventions/Control_2 Placebo beverages were given daily for 5 wk, and whole-body energy expenditure, respiratory quotient and adiposity were measured by indirect calorimetry at a resting state and after 2-hr cold exposure.
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
30 years-old >=
Gender Male
Key inclusion criteria 1. Healthy male volunteers
2. Aged 20-30 years
3. Be able to provide written informed consent
Key exclusion criteria Body mass index >=30
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsushita, Mami
Organization Tenshi College
Division name School of Nursing and Nutrition
Zip code
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Email matsushita@tenshi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Matsushita, Mami
Organization Tenshi College
Division name School of Nursing and Nutrition
Zip code
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Homepage URL
Email matsushita@tenshi.ac.jp

Sponsor
Institute Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department

Funding Source
Organization Grants-In-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 天使大学(北海道) Tenshi College (Hokkaido)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.kao.com/jp/corp_news/2014/20140826_001.html?cid=corp_jp_ja_rss
Number of participants that the trial has enrolled
Results
Whole-body energy expenditure (EE) at 27C and 19C was measured in 10 healthy male subjects, before and 5 wk after daily ingestion of beverages containing 1080 mg or 0 mg (placebo) catechin. Before the ingestion of either catechin or placebo, EE at 19C was slightly higher than that at 27C. After the 5-wk ingestion of catechin, EE at 19C was markedly higher than that at 27C, while EE at 27C was similar to that before the ingestion. Cold-induced thermogenesis (CIT), calculated from the difference in EE at 19C and 27C, was about 198 kcal/day after catechin ingestion, which was significantly higher than that before the ingestion (92 kcal/day). After placebo ingestion, CIT was 99 kcal/day, being almost equal to that before the ingestion (70 kcal/day). Cold-induced fat oxidation also increased significantly after the catechin treatment, but not after the placebo treatment. No notable effect of catechin ingestion was found in body weight and body fat content. Considering that CIT is an index of brown adipose tissue (BAT) activity, the present results suggest that daily ingestion of catechin may recruit BAT in humans.

1. The 3rd International Conference on Recent Advances and Controversies in Measuring Energy Metabolism, October, 2014, Tokyo, Japan
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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 07 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 28 Day
Last modified on
2015 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018998

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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