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Recruitment status Completed
Unique ID issued by UMIN UMIN000006781
Receipt No. R000008024
Scientific Title Effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans
Date of disclosure of the study information 2011/11/28
Last modified on 2011/11/28

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Basic information
Public title Effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans
Acronym Human brown adipose tissue and ginger
Scientific Title Effects of pungent ingredients of ginger on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym Human brown adipose tissue and ginger
Region
Japan

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

Objectives
Narrative objectives1 To examine the acute effects of pungent ingredients of ginger 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 40 mg an extract of Grains of Paradise (a West African spice obtained from Aframomum melegueta, a species in the ginger family) were measured at every 30min for 2hr by indirect calorimetry. The skin temperature response was also examined.
Interventions/Control_2 hole-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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 20

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
Email

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
Email saito@tenshi.ac.jp

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
2011 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially 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 Grains of Paradise extract (GP) or placebo was measured for 2hr in 19 healthy male volunteers. Brown adipose tissue (BAT) activity was undetectable and high in 7 and 12 subjects, respectively. Resting EE of the BAT-positive group was 1,473 +- 202 kcal/day (mean +- SD), not differing from that in the BAT-negative group (1,551 +- 132 kcal/day). After oral ingestion of GP, EE of the BAT-positive group increased in 2 hr by 5.9 +- 5.1 kcal/2hr, which was greater (P<0.05) than that of the BAT-negative group (-0.8+- 6.4 kcal/2hr). 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.Symposium "Brown Adipose Tissue 2011 Update" (June 18, 2011, Sapporo), Abstract book, p.72.
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
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 11 Month 01 Day
Date trial data considered complete
2011 Year 11 Month 01 Day
Date analysis concluded
2011 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 28 Day
Last modified on
2011 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008024


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