UMIN-CTR Clinical Trial

Public title

The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.

Acronym

The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.

Scientific Title

The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.

Scientific Title:Acronym

The short-Term effect of a grain-derived processed food product ingestion on visceral fat area : a randomized controlled trial.

Region

Japan

Condition

healthy humans

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of grain- derived processed product on visceral fat area

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

visceral fat area
4-wk repeated consumption

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

control
*body weight measurement every day at home
*visceral fat area measurement every 2-wk.

Interventions/Control_2

active: product code; S-001
*4-wk repeated consumption
*body weight measurement every day at home
*visceral fat area measurement every 2-wk

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1, 23<=BMI<30
2, 20<=Age<65 of healthy men and women
3, provided written informed consent from subjects

Key exclusion criteria

1, can't attend all of test SCR, 0,2 and 4-wk
2, liver, kidney and heart disease, or disorder of respiration endocrine, metabolism, nervous system consciousness, or diabetes, or other diseases
3, parson deviation from reference value of clinical trial, and are diagnosed with doctor
4, surgery or therapy within 2 months before the trial
5, medicine user for hyperglycaemia, lipidemia, or hypertension
6, user of supplements or foods with health claim
7, unpleasant feeling during blood drawing
8, donated 200mL or more blood within l month before the trial
9, skin disease, metal allergy and implanted pacemaker
10, changes in weight of 3kg or more within 3 month before the study
11, shift worker
12, business trip and travel planned for 5 consecutive days or more
13, allergies against any constituents in the test diet
14, heavy user of alcohol (800mL<=ingestion beer)
15, other clinical study or who intended to participate in one during the study period
16, can't write the dietary record, life record and body weight record
17, disagree with explanation for study
18, judged to be inappropriate as subject by physician in charge

Target sample size

20

Name of lead principal investigator

1st name	Haruna
Middle name
Last name	Miura

Organization

Higashi sinjyuku clinic

Division name

Director

Zip code

169-0072

Address

1-11-3 Okubo Shinjuku-ku Tokyo

TEL

03-6233-8581

Email

d-kameda@mediffom.co.jp

Name of contact person

1st name	Junko
Middle name
Last name	Fujii

Organization

New drag Research Center, Inc

Division name

Clinical Research Development

Zip code

105-0001

Address

2-7-5 Toranomon Minato-ku Tokyo

TEL

03-5510-6908

Homepage URL

Email

j-fujii@ndrcenter.co.jp

Institute

Higashi sinjyuku clinic

Institute

Department

Personal name

Organization

Kao corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miyawaki orthopedics clinic IRB

Address

3-1-6 Ariake-cho, Eniwa city, Hokkaido

Tel

0123-33-4026

Email

d-kameda@mediffom.co.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

2017

Year

01

Month

10

Day

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

44

Results

There was a significant difference in primary outcome

Results date posted

2019

Year

07

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

healthy human

Participant flow

43 participants completed and 40 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

visceral fat area

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

28

Day

Date of IRB

2016

Year

11

Month

29

Day

Anticipated trial start date

2016

Year

12

Month

16

Day

Last follow-up date

2017

Year

02

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

15

Day

Last modified on

2019

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028241