UMIN-CTR Clinical Trial

Public title

Chronic effects of capsinoids ingestion on energy expenditure by brown adipose tissue in humans

Acronym

Brown adipose tissue and capsinoids

Scientific Title

Chronic effects of capsinoids ingestion on energy expenditure by brown adipose tissue in humans

Scientific Title:Acronym

Brown adipose tissue and capsinoids

Region

Japan

Condition

Healthy male volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the chronic effects of a capsaicin analogue, capsinoids, 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

Primary outcomes

Whole body energy expenditure assessed from respiratory gas analysis

Key secondary outcomes

Respiratory quotient
Skin temperature
Body fat content

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

Capsules containing 9 mg capsinoids were given daily for 4-6 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 4-6 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

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

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

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 6 weeks after daily ingestion of capsinoids (9mg/day) or placebo. Before the ingestion, EE at 19C was slightly and insignificantly higher than that at 27C. However, after 6-week ingestion of either capsinoids or placebo EE at 19C was significantly 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 205.1 kcal/day after capsinoids ingestion, which was much higher that that before the ingestion (20.6 kcal/day). After placebo ingestion, CIT was 81.0 kcal/day, being almost equal to that before the ingestion (64.8 kcal/day), but significantly lower than that after capsinoids ingestion. No notable effect of capsinoids 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 capsinoids may recruit BAT in humans.

1. Experimental Biology 2012, April 23, 2012, San Diego, USA, Minisymposium, Abstract No.252.4

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

2011

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2012

Year

02

Month

01

Day

Date of closure to data entry

2012

Year

05

Month

01

Day

Date trial data considered complete

2012

Year

05

Month

01

Day

Date analysis concluded

2012

Year

06

Month

01

Day

Other related information

Registered date

2011

Year

12

Month

01

Day

Last modified on

2012

Year

06

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008059