UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035624 |
|---|---|
| Receipt number | R000040547 |
| Scientific Title | Suppressive effect of test food on the postprandial triglyceride level. -A randomized, double blind, placebo controlled, cross-over study- |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/08/06 19:06:33 |
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Basic information
Public title
Suppressive effect of test food on the postprandial triglyceride level. -A randomized, double blind, placebo controlled, cross-over study-
Acronym
Suppressive effect of test food on the postprandial triglyceride level.
Scientific Title
Suppressive effect of test food on the postprandial triglyceride level. -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym
Suppressive effect of test food on the postprandial triglyceride level.
Region
| Japan |
Condition
Condition
Adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test food on the postprandial triglyceride level of subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the curve for postprandial serum triglyceride leve.
Key secondary outcomes
Area under the curve for Remnant-like particle cholesterol, and serum triglyceride levels and Remnant-like particle cholesterol of before, 2, 3, 4 and 6 hours after high fat meal ingestion.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion).
Interventions/Control_2
Intake of placebo (single ingestion) - washout period - intake of test food (single 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Males and females from 20 to 64 years of age.
2)Subjects whose fasting serum triglyceride levels is less than 200 mg/dL.
3)Subjects who are available to the scheduled visits including overnight stay in the hospital.
4)Subjects who agree to participate in the study and who can sign, seal and date the consent forms by themselves.
Key exclusion criteria
1)Subjects who have serious medical history or who had digestive tract resectional surgery (except for appendectomy).
2)Subjects who routinely use medicine, supplements, FOSHU and/or health food which may affect the result of the study.
3)Subjects who have allergy to the test food or high fat meal and have extreme lactose intolerance or diarrhea.
4)Subjects who are planning to become pregnant during the study or are pregnant or lactating.
5)Heavy user of alcohol or heavy smokers.
6)Subjects who are judged as inappropriate to participate in the study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ishikawa |
Organization
Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name
internal medicine
Zip code
004-0004
Address
2-1-30, Atsubetsuhigashi4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL
080-6082-7362
kanamori@hpgr.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Limited
Division name
Food Service Division
Zip code
060-0061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061 Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Hokubukai beauty hill hospital ethics review committee
Address
No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel
011-882-0111
wakimoto@ughp-cpc.jp
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
医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040547
