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
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
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
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
