UMIN-CTR Clinical Trial

Public title

Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study

Acronym

Effect of cereal-derived processed product on metabolism

Scientific Title

Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study

Scientific Title:Acronym

Effect of cereal-derived processed product on metabolism

Region

Japan

Condition

healthy humans

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Effect of cereal-derived processed product on metabolism, and clarify its mechanism.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fat oxidation

Key secondary outcomes

Serum glucose-dependent insulinotropic polypeptide and insulin.
Energy expenditure

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of control food (one time)

Interventions/Control_2

Intake of test food (one time)

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

Key inclusion criteria

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

Key exclusion criteria

1; suffering from liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2; LDL-cholesterol>=140mg/dL, triglyceride>=150mg/dL, Systolic blood pressure>=140mmHg, diastolic pressure>=90mmHg, fasting blood glucose>=126mg/dL,
3; taking medication or operation by severe sickness and injury within 2 months before the trial,
4; becoming unpleasant feeling after blood test or energy expenditure analyzing (metabolic chamber, collecting of breath by mask or hood)
5; making blood donation of 200 mL or more within l month of this trial
6; medicine user for hyperglycemia, hyperlipidemia, or hypertension,
7; unstable measurement of energy expenditure
8; heavy drinker(more than 30 g/day alcohol everyday)
9; user of supplements or foods with health claim
10; having variability in body weight more than +-2.0 kg within 1 month of this trial
11; business trip or travel planned for 5 consecutive days or more during this trial
12; having allergy to gum
13; having allergy to the ingredients included in the test meal
14; smoker
15; participating subject of other clinical study or having a plan during this study period,
16; judged to be inappropriate for the study based on the access record by medical doctor.
17; judged to be inappropriate as subject by physician in charge

Target sample size

15

Name of lead principal investigator

1st name	Noriko
Middle name
Last name	Osaki

Organization

Kao Corporation

Division name

Health Care Food Research Labs

Zip code

131-8501

Address

2-1-3 Bunka Sumida-ku Tokyo

TEL

03-5630-7224

Email

osaki.noriko@kao.co.jp

Name of contact person

1st name	Chizuka
Middle name
Last name	Suzuki

Organization

Kao Corporation

Division name

Health Care Food Research Labs

Zip code

131-8501

Address

2-1-3 Bunka Sumida-ku Tokyo

TEL

03-5630-7456

Homepage URL

Email

suzuki.chizuka@kao.co.jp

Institute

Kao Corporation

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

Kao Corporation Human Research IRB

Address

2-1-3 Bunka Sumida-ku Tokyo

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com

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

2016

Year

10

Month

24

Day

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Published

URL related to results and publications

works in progress

Number of participants that the trial has enrolled

22

Results

Significant difference in the primary outcome

Results date posted

2019

Year

08

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Healthy subjects

Participant flow

21 participants completed and 21 subjects were incorporated into the analyses

Adverse events

No adverse effect related to the test diets reported

Outcome measures

Postprandial fat oxidation

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2016

Year

10

Month

12

Day

Date of IRB

2016

Year

10

Month

24

Day

Anticipated trial start date

2016

Year

10

Month

24

Day

Last follow-up date

2016

Year

12

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

21

Day

Last modified on

2019

Year

08

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028166