UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016361 |
|---|---|
| Receipt number | 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 11:54:32 |
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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
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
matsushita@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018998
