UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006073 |
|---|---|
| Receipt number | R000007186 |
| Scientific Title | Effects of capsinoids on energy expenditure by brown adipose tissue in humans |
| Date of disclosure of the study information | 2011/07/29 |
| Last modified on | 2011/07/29 15:53:10 |
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Basic information
Public title
Effects of capsinoids on energy expenditure by brown adipose tissue in humans
Acronym
Human brown adipose tissue and capsinoids
Scientific Title
Effects of capsinoids on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym
Human brown adipose tissue and capsinoids
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the acute effects of a capsaicin analogue, capsinoids, on energy expenditure and to analyze its relation to brown adipose tissue activity 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
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
Whole-body energy expenditure and respiratory quotient after oral ingestion of capsules containing 9 mg capsinoids were measured at every 30min for 2hr by indirect calorimetry. The skin temperature response was also examined.
Interventions/Control_2
Whole-body energy expenditure and respiratory quotient after oral ingestion of placebo capsules were measured at every 30min for 2hr by indirect calorimetry. The skin temperature response was also examined.
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
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saito, Masayuki |
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saito, Masayuki |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Special Research Grant of Tenshi College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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 Collge (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Whole-body energy expenditure (EE) after oral ingestion of capsinoids or placebo was measured for 2hr in 18 healthy male volunteers. Brown adipose tissue (BAT) activity was undetectable and high in 8 and 10 subjects, respectively. Resting EE of the BAT-positive group was 1,460 +/- 54 kcal/day (mean +/- SEM), not differing from that in the BAT-negative group (1,506 +/- 37 kcal/day). After oral ingestion of capsinoids, EE of the BAT-positive group increased in 0.5-1 hr by 3.6 +/- 0.6 kcal/hr, which was greater (P<0.01) than that of the BAT-negative group (0.4 +/- 0.9 kcal/hr). Placebo ingestion produced no significant change in both groups. Neither capsinoids nor placebo changed skin temperature in various regions including those close to BAT deposits.
1. 65th Annual Meeting of Japanese Society of Nutrition and Food Science (May 15, 2011, Tokyo), Abstract book, p.206
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 29 | Day |
Last modified on
| 2011 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007186
