UMIN-CTR Clinical Trial

Public title

A study for an effect of dietary fat oxidation after ingestion of the plant-derived processed food.

Acronym

Elucidation of the action mechanism of the plant-derived processed food.

Scientific Title

A study for an effect of dietary fat oxidation after ingestion of the plant-derived processed food.

Scientific Title:Acronym

Elucidation of the action mechanism of the plant-derived processed food.

Region

Japan

Condition

Nothing (healthy subjects)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the plant-derived processed food on dietary fat oxidation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Dietary fat oxidation after 14-day continuous diet intervention period (breath analysis data)

Key secondary outcomes

Postprandial energy expenditure, Postprandial total fat oxidation, Postprandial respiratory quotient.

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

Treatment

Type of intervention

Food

Interventions/Control_1

Intake test diet (product code: AD-01) for 2 weeks (one serving size per day) > wash out more than 3 weeks > intake control diet (product code: NO-01) for 2 weeks (one serving size per day)

Interventions/Control_2

Intake control diet (product code: NO-01) for 2 weeks (one serving size per day) > wash out more than 3 weeks > intake test diet (product code: AD-01) for 2 weeks (one serving size per day)

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

35

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Age>=35 and <65 years
2.BMI>=23 and <= 30 kg/m2
3.Person who provides informed consent by a document.

Key exclusion criteria

1.Person who is difficult to participate due to have a liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases
2.Person who has surgical history for disease or injury within the last two months prior to the current study.
3.Person who takes a medicine for hyperglycaemia, lipid metabolism, hypertension.
4.Person who habitually takes the foods for specified health uses (FOSHU), functional food, or dietary supplements (capsules) affecting current study (e.g. fat weight, serum lipid level). (Except for subjects who can stop consume them after informed consent).
5.Person who was experienced unpleasant feeling during blood collection.
6. Person who has donated over 200 mL of blood within the last one month prior to the current study.
7.Person whose weight changes more than 2 kg during past one year.
8.Person who is shift worker
9.Person who will plan to go long term business trip or trip (more than 5 consecutive days) during current study.
10.Person who is not used to intake shortbread.
11.Person who has possibility for allergic reaction to food or rubber.
12.Person who drinks a lot of alcohol. (more than 30 g/day alcohol)
13.Person who can't keep a diary during current study.
14.Person who can't note daily diet during current study.
15.Person who is smoker.
16.Person who is before menopause.
17.Person who can't accept to access past medical chart.
18.Person who has participated in other clinical study or are planned to participate in other clinical study.
19.Person who can't agree current informed consent.
20.Person who is judged to be inappropriate for current study based on the medical chart by medical doctor.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Noriko Osaki

Organization

Kao Corporation

Division name

Health Care Food Research

Zip code

Address

2-1-3, Bunka, Sumida-ku, Tokyo

TEL

+81-3-5630-7266

Email

osaki.noriko@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co. Ltd

Division name

operational management of clinical research

Zip code

Address

7-3-1, hongo, Bunkyo-ku, Tokyo

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.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

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

Date of disclosure of the study information

2016

Year

02

Month

09

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

Terminated

Date of protocol fixation

2016

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

08

Day

Last modified on

2016

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024163