UMIN-CTR Clinical Trial

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

Healthy male volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Whole body energy expenditure assessed from respiratory gas analysis

Key secondary outcomes

Respiratory quotient,
Skin temperature

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

LSI Sapporo Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

天使大学（北海道）　　 Tenshi College (Hokkaido)

Date of disclosure of the study information

2011

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2011

Year

11

Month

28

Day

Last modified on

2011

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008024