UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022758 |
|---|---|
| Receipt number | 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 18:33:50 |
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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
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
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Kao Corporation
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026219
