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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022758
Receipt No. R000026219
Scientific Title A study for an effect of dietary fat oxidation after repeated ingestion of the plant-derived processed food.
Date of disclosure of the study information 2016/07/01
Last modified on 2016/10/24

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Basic information
Public title A study for an effect of dietary fat oxidation after repeated ingestion of the plant-derived processed food.
Acronym Effect of the plant-derived processed food on dietary fat metabolism.
Scientific Title A study for an effect of dietary fat oxidation after repeated ingestion of the plant-derived processed food.
Scientific Title:Acronym Effect of the plant-derived processed food on dietary fat metabolism.
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 28 days repeated ingestion (breath analysis data)
Key secondary outcomes Basal metabolic rate,
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: A-001) for 28 days (one serving size per day) > wash out more than 28 days > intake control diet (product code: C-001) for 28 days (one serving size per day)
Interventions/Control_2 Intake control diet (product code: C-001) for 28 days (one serving size per day) > wash out more than 28 days > intake test diet (product code: A-001) for 28 days (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 the study due to presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases.
2.Person who has skin infection or dysfunction on abdominal.
3.Person who has constipation more than 5 days.
4.Person whose waist circumference is less than 55 cm or more than 140 cm.
5.Person who has surgical or treatment history for disease or injury within two months before the trial. (except for common cold, abdominal pain, allergic rhinitis)
6.Person who taking medicine for hyperglycaemia, lipid metabolism, or hypertension.
7.Person who experienced unpleasant feeling during drawing blood.
8.Person who has donated 200 mL or more blood within one month before the trial.
9.Person who has possibility for allergies to ingredients in the test food or equipment used for indirect calorimetry.
10.Person whose weight changes more than +-5 kg within one month before the trial.
11.Person who is shift worker.
12.Person who planned business trip lasting 5 consecutive days or more.
13.Person who habitually takes the FOSHU (foods for specified health uses), functional food, or dietary supplements affecting current study (e.g. serum cholesterol, serum triglyceride, fat weight, blood glucose). (Except for person who can stop consume them after informed consent).
14.Person who inability or unwillingness to conform to the alcohol limitation (more than 30 g/day alcohol).
15.Person who inability or unwillingness to record diary during current study.
16.Person who inability or unwillingness to record daily diet during current study.
17.Person who is smoker.
18.Person who participating or planning to participate in other clinical studies.
19.Person who can't agree current informed consent.
20.Person who determined to be unqualified by the supervising physician based on the medical record or other reasons.
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 Shinpei Tomita
Organization New drug research center Co. Ltd
Division name Research Division
Zip code
Address 452-1, Toiso, Eniwa-shi, Hokkaido
TEL +81-123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute Kao Corporation
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)

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 07 Month 01 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 05 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 09 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 06 Month 15 Day
Last modified on
2016 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026219

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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