UMIN-ICDS Clinical Trial

Public title

Study on the Effect of Green Propolis on Human Brown Fat

Acronym

Study on the Effect of Green Propolis on Human Brown Fat

Scientific Title

Study on the Effect of Brazilian Green Propolis Consumption on Human Brown Fat and Energy Metabolism

Scientific Title:Acronym

Study on the Effect of Brazilian Green Propolis Consumption on Human Brown Fat and Energy Metabolism

Region

Japan

Condition

Healthy male volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of Brazilian green propolis consumption on energy expenditure and body fat, and to determine its relationship with brown fat

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cold-induced thermogenesis (difference in oxygen consumption at room temperature of 27 degree and 19 degree) as an index of brown fat activity

Key secondary outcomes

(1) Change in body fat mass
(2) Change in body surface temperature during cold exposure
(3) Change in core body temperature during cold exposure
(4) Changes in the degree of fatty acid oxidation and carbohydrate oxidation

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved 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 508 mg propolis were given daily for 4 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 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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1. Those with body mass index from18.5 to 30.0
2. Those who provided informed consent forparticipation

Key exclusion criteria

1. Those who are receiving treatment, whether seasonal, chronic, or acute, by medication, therapy, or treatment
2. Those who have a history of asthma
3. Those who are allergic to bee products (such as honey), conifers, poplar, peruvian balsam (a resin obtained from pine trees in South America), or salicylic acid (included in anti-inflammatory medicines, therapeutics for wart, corn, etc.)
4. Those who will be taking other dietary supplements during the study period
5. Those who deemed ineligible by the Principal Investigator

Target sample size

16

Name of lead principal investigator

1st name	Yuko
Middle name
Last name	Okamatsu

Organization

Hokkaido University

Division name

Faculty of Veterinary Medicine

Zip code

060-0818

Address

Kita-ku N18 W9, Sapporo, Hokkaido

TEL

011-706-5205

Email

y-okamatsu@vetmed.hokudai.ac.jp

Name of contact person

1st name	Yuko
Middle name
Last name	Okamatsu

Organization

Hokkaido University

Division name

Faculty of Veterinary Medicine

Zip code

060-0818

Address

Kita-ku N18 W9, Sapporo, Hokkaido

TEL

011-706-5205

Homepage URL

Email

y-okamatsu@vetmed.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Organization

Yamada Bee Company, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committees of NISHI-UMEDA Clinic for Asian Medical Collaboration

Address

3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka

Tel

06-4797-5660

Email

jimukyoku@amc-clinc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Preinitiation

Date of protocol fixation

2023

Year

10

Month

27

Day

Date of IRB

2023

Year

10

Month

27

Day

Anticipated trial start date

2023

Year

11

Month

13

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

13

Day

Last modified on

2023

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060210