UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038723
Receipt number R000043942
Scientific Title Effects of soy protein on brown adipose tissue activity
Date of disclosure of the study information 2019/12/01
Last modified on 2021/02/17 18:03:10

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Basic information

Public title

Effects of soy protein on brown adipose tissue activity

Acronym

Effects of soy protein on brown adipose tissue activity

Scientific Title

Effects of soy protein on brown adipose tissue activity

Scientific Title:Acronym

Effects of soy protein on brown adipose tissue activity

Region

Japan


Condition

Condition

Healthy males

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate whether soy protein intake modulates circulating peptide hormone level and brown adipose tissue activity in healthy young male subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effects of soy protein intake for 2 weeks on brown adipose tissue activity

Key secondary outcomes

Effects of soy protein intake for 2 weeks on circulating peptide hormone level


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Two weeks intake of 10 g soy protein per day

Interventions/Control_2

Two weeks intake of placebo.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Healthy young subjects over 18 years old

Key exclusion criteria

Subject who have chronic diseases

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hirokazu
Middle name
Last name Taniguchi

Organization

Kyoto prefectural university

Division name

Graduate school of life and environmental sciences

Zip code

606-8522

Address

1-5 Hangi-cho, Shimogamo, Kyoto

TEL

+81-75-703-5415

Email

hirokazu-t@kpu.ac.jp


Public contact

Name of contact person

1st name Hirokazu
Middle name
Last name Taniguchi

Organization

Kyoto prefectural university

Division name

Graduate school of life and environmental sciences

Zip code

606-8522

Address

1-5 Hangi-cho, Shimogamo, Kyoto

TEL

+81-75-703-5415

Homepage URL


Email

hirokazu-t@kpu.ac.jp


Sponsor or person

Institute

Kyoto prefectural university

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto prefectural university

Address

1-5 Hangi-cho, Shimogamo, Kyoto

Tel

+81-75-703-5147

Email

kikaku@kpu.ac.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 01 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1186/s40101-020-00226-w

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1186/s40101-020-00226-w

Number of participants that the trial has enrolled

21

Results

The randomized crossover trial showed that 2-week beta-conglycinin intake did not affect serum fibroblast growth factor 21 (FGF21) level and brown adipose tissue activity, whereas changes in baseline levels of serum FGF21 were positively correlated with change in brown adipose tissue activity.
In addition, there was significant correlation between the changes in serum FGF21 level and brown adipose tissue activity in the beta-conglycinin group, but not in the placebo group.

Results date posted

2021 Year 02 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy young male subjects

Participant flow

Twenty-one subjects were pataicipated a single-blinded randomized crossover trial of 2 weeks. The subjects were allocated into the beta conglycinin group (n = 10) or the placebo group (n = 11). After baseline measurements, 2 subjects from the placebo group were excluded because of difficulties in collecting blood samples. Final measurements were performed after the 2-week interventional period.

Adverse events

N/A

Outcome measures

Serum FGF21 levels, blood metabolic parameters, energy and nutrients intake, and brown adipose tissue activity

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 06 Month 04 Day

Anticipated trial start date

2019 Year 11 Month 06 Day

Last follow-up date

2019 Year 12 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 29 Day

Last modified on

2021 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043942


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name