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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
