UMIN-CTR Clinical Trial

Public title

A study for evaluating the effect of repeated intake of the plant-derived processed food on postprandial fat oxidation.

Acronym

Effect of the plant-derived processed food on postprandial fat metabolism in human subjects.

Scientific Title

A study for evaluating the effect of repeated intake of the plant-derived processed food on postprandial fat oxidation.

Scientific Title:Acronym

Effect of the plant-derived processed food on postprandial fat metabolism in human subjects.

Region

Japan

Condition

Nothing (healthy subjects)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of repeated intake of the plant-derived processed food on postprandial fat oxidation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postprandial fat oxidation

Key secondary outcomes

Postprandial respiratory quotient, Postprandial energy expenditure.

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: A-001) for 2 weeks (one serving size per day) > wash out more than 2 weeks > intake control diet (product code: C-001) for 2 weeks (one serving size per day)

Interventions/Control_2

intake control diet (product code: C-001) for 2 weeks (one serving size per day) > wash out more than 2 weeks > intake test diet (product code: A-001) 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

25

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male

Key inclusion criteria

1. Subjects who are male and belong to KAO Corporation.
2. Age>=25 and <65 years
3. Subjects who can approve their medical record access and agree with the study protocol following explanation of current study.
4. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1. Subjects having a liver, kidney, or heart disease, respiratory disorder, endocrine disorder, metabolic disorder, nervous disorder, consciousness disorder, diabetes, or other diseases.
2. Subjects who have surgical history for disease or injury within the last two months prior to the current study.
3. Subjects who were experienced unpleasant feeling during blood collection or energy expenditure analyzing (metabolic chamber, hood, or mask).
4. Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the current study.
5. Subjects who take a medicine for hyperglycaemia, lipidemia, or hypertension.
6. Subjects whose visceral fat area is below 25 cm2.
7. Subjects whose energy expenditure is not stable.
8. Subjects who drink a lot of alcohol. (more than 30 g/day alcohol)
9. Subjects who habitually take 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)
10. Subjects whose weight change more than 2 kg during past 2 months.
11. Subjects who will plan to go long term business trip or travel (more than 5 days) during current study.
12. Subjects who have allergy against rubber.
13. Subjects who are not used to intake test diet.
14. Subjects who are smoker.
15. Subjects who have possibility for allergic reaction to food.
16. Subjects who can not intake test diet during clinical study period.
17. Subjects who have participated in other clinical study or are planned to participate in other clinical study.
18. Subjects who are judged to be inappropriate for the study based on the access record by medical doctor.
19. Subjects judged as unsuitable for the study by the investigator or medical doctor for other reason.

Target sample size

30

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

+81-3-5630-7224

Email

osaki.noriko@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Yasutoshi Ando

Organization

Kao Corporation

Division name

Health care food Research center

Zip code

Address

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

TEL

+81-3-5630-7476

Homepage URL

Email

andou.yasutoshi@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

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

2015

Year

08

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Nineteen healthy subjects participated in this study, and postprandial energy metabolism was evaluated using indirect calorimetry followed by 14-d repeated pre-consumption of TAG (rapeseed oil) as a control or ALA-DAG. As a primary outcome, ALA-DAG induced significantly higher postprandial fat oxidation than TAG. As a secondary outcome, carbohydrate oxidation tended to be decreased. In addition, postprandial energy expenditure was significantly increased by ALA-DAG compared to TAG. These findings suggest that daily ALA-DAG consumption stimulates dietary fat utilization as energy after a meal, as well as greater diet induced thermogenesis in healthy humans. In conclusion, repeated consumption of ALA-DAG enhanced postprandial fat metabolism after a meal, which may partially explain its visceral fat area-reducing effect.

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

Main results already published

Date of protocol fixation

2015

Year

08

Month

25

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

08

Month

28

Day

Last modified on

2016

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021490