UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022352
Receipt number R000025250
Scientific Title Effect of a plant-derived processed food on fat metabolism
Date of disclosure of the study information 2016/05/19
Last modified on 2019/07/31 09:56:08

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Basic information

Public title

Effect of a plant-derived processed food on fat metabolism

Acronym

Effect of a plant-derived processed food on dietary fat oxidation

Scientific Title

Effect of a plant-derived processed food on fat metabolism

Scientific Title:Acronym

Effect of a plant-derived processed food on dietary fat oxidation

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of a plant-derived processed food on fat metabolism.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fat oxidation measures after 1wk repeated ingestion

Key secondary outcomes



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

Ingestion of test diet (code name: A-004) for 1 weeks > wash out more than 1 weeks > Ingestion of control diet (code name: C-004) for 1 weeks.
dose: one serving size per day
Energy metabolism will be measured after 1wk repeated ingestion

Interventions/Control_2

Ingestion of control diet (code name: C-004) for 1 weeks > wash out more than 1 weeks > Ingestion of test diet (code name: A-004) for 1 weeks.
dose: one serving size per day
Energy metabolism will be measured after 1wk repeated ingestion

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, Aged between 35 and 64
2, BMI >= 23 and <30 kg/m2
3, Person who provides informed consent by a document

Key exclusion criteria

1, Hepatic, renal, or cardiac diseases, respiratory impairment, endcrinopathy, metabolic impairment, neuropathy, impaired mental status, diabetes, other disorders that would make participation in a study difficult
2, Surgery for disease or injury within 2 months before the study
3, Treatment with medication to improve glucose metabolism, fat metabolism, or blood pressure
4, Regular consumption Food with Health Claims (Food for Specified Health Uses [FOSHU], Foods with functional Claims, and nutritional food supplements) and supplements
5, Individual experienced unpleasant feeling during blood drawing.
6, Donation of 200mL or more of blood within 1month before the study
7, Heavy smoker (21 cigarettes a day or more)
8, Inability to continuous administration in the test diets
9, Potential to exhibit allergic symptoms to the ingredients in the test diets
10, Shift-worker
11, Intention to live or travel overseas for an extended period (6 or more consecutive days) during the study period (including wash-out periods)
12, Inability to record a diet for 9 days (3 days x 3 times)
13, Lock of consent to view previous medical records
14, Current participation in another clinical study or who intended to participate in one during the study period
15, Person who are considered inappropriate by medical doctors.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Ono

Organization

MEDICS Hongo Clinic

Division name

Director

Zip code


Address

2-2-6 Mukogaoka, Bunkyo-ku, Tokyo

TEL

03-6801-9761

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoma Shimizu

Organization

TES Holdings Co. Ltd

Division name

Administrative Department of Clinical Trials

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

MEDICS Hongo Clinic

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 05 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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 04 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2019 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025250


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name