UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012974 |
|---|---|
| Receipt number | R000015163 |
| Scientific Title | Chronic effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2014/01/27 15:11:40 |
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Basic information
Public title
Chronic effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans
Acronym
Brown adipose tissue recruitment and ginger
Scientific Title
Chronic effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym
Brown adipose tissue recruitment and ginger
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the chronic effects of pungent ingredients of ginger 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
Capsules containing 40 mg of an extract of Grains of Paradise (West African spice obtained from Aframomum melegueta, a species in the ginger family) were given daily for 5 weeks, 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_2
Placebo capsules were given daily for 5 weeks, 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
15
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
saito@tenshi.ac.jp
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
011-741-1051
Homepage URL
saito@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
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
| 2014 | Year | 01 | Month | 30 | 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
Nine healthy male volunteers participated in the present study. Before and after daily ingestion of either Grains of Paradise extract (GP, 40 mg/day) or placebo (GP 0 mg/d) for 5 wk, whole-body energy expenditure (EE) was measured at thermoneutral condition (27˚C) and after 2-h cold exposure at 19˚C. Body fat content was also monitored. Resting EE at thermoneutral condition did not change after either the GP and placebo treatments. Response of EE to acute cold exposure (CIT) increased and body fat content decreased significantly after the 5-wk GP treatment. The placebo treatment did not change CIT and body fatness. As CIT is predicted index of BAT activity, our results suggest that repeated ingestion of GP recruits BAT and thereby increases EE and decreases body fatness.
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
| 2011 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 27 | Day |
Last modified on
| 2014 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015163
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| Registered date | File name |
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