UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021181
Receipt number R000024423
Scientific Title A study for an effect of dietary fat oxidation after ingestion of the plant-derived processed food.
Date of disclosure of the study information 2016/02/24
Last modified on 2016/09/26 10:20:53

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Basic information

Public title

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

Acronym

Effect of alpha-linolenic acid enriched diacylglycerol on dietary fat oxidation.

Scientific Title

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

Scientific Title:Acronym

Effect of alpha-linolenic acid enriched diacylglycerol on dietary fat oxidation.

Region

Japan


Condition

Condition

Nothing (healthy subjects)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Interventional


Study design

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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake test diet (product code: AD-02) for 2 weeks (one serving size per day) > wash out more than 3 weeks > intake control diet (product code: NO-02) for 2 weeks (one serving size per day)

Interventions/Control_2

Intake control diet (product code: NO-02) for 2 weeks (one serving size per day) > wash out more than 3 weeks > intake test diet (product code: AD-02) 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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

TES Holdings Co. Ltd

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 02 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 02 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Journal of Oleo Science
Accept:25-Sep-2016
66(2),2017
Title:Alpha linolenic acid-enriched diacylglycerol consumption enhances dietary fat oxidation in healthy subjects: A randomized double-blind controlled trial
Author:Yasutoshi Ando, Shinichiro Saito, Nami Yamanaka, Chizuka Suzuki, Takahiro Ono, Noriko Osaki, and Yoshihisa Katsuragi
Abstract:Consumption of alpha linolenic acid-enriched diacylglycerol (ALA-DAG) reduces visceral fat area. In this study, we performed a randomized, placebo-controlled, double-blind, crossover intervention trial to investigate the effect of ALA-DAG on dietary fat oxidation in comparison with control triacylglycerol (TAG). Each subject (n=16) consumed either 2.5 g/d of ALA-DAG or TAG for 14-d, separated by a 14-d washout period. At the end of each consumption period, we assessed dietary fat oxidation. ALA-DAG consumption significantly enhanced dietary fat utilization as energy compared to TAG consumption.


Management information

Registered date

2016 Year 02 Month 24 Day

Last modified on

2016 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024423


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name