UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for an effect of dietary fat oxidation after ingestion of the plant-derived processed food.
Title of the study (Brief title)	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	Noriko Osaki
Organization	Kao Corporation
Division name	Health Care Food Research
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	Ryoma Shimizu
Organization	TES Holdings Co. Ltd
Division name	operational management of clinical research
Address	7-3-1, hongo, Bunkyo-ku, Tokyo
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co. Ltd
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024423