UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027767 |
|---|---|
| Receipt number | R000031820 |
| Scientific Title | A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study) |
| Date of disclosure of the study information | 2017/06/21 |
| Last modified on | 2017/12/14 15:14:29 |
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Basic information
Public title
A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study)
Acronym
A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride.
Scientific Title
A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study)
Scientific Title:Acronym
A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of serum triglyceride level and AUC (area under the curve)(0-6hrs)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Seasoning containing functional ingredients, vegetable (1 day)
Interventions/Control_2
Seasoning not containing functional ingredients, vegetable
Interventions/Control_3
No intervention
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy individuals aged 20 to 60 years old
(2) Individuals whose fasting serum triglyceride levels are from 120 mg/dL to 199 mg/dL.(3) Individuals giving written informed consent
Key exclusion criteria
(1) Individuals who use oral medication, supplements and/or functional foods affecting lipid metabolism
(2) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(3) Individuals who are suffered from or under treatment of serious disease (e.g., heart disease, liver disease, kidney disease, and/or digestive disease)
(4) Individuals who are under treatment of alcohol dependence
(5) Individuals who are extremely irregular in eating habits
(6) Individuals who declare the allergy symptoms against drugs and/or foods
(7) Individuals who are participating in other clinical trials of drugs or health food, who participated in the last 4 weeks, or who are willing to participate after giving the informed consent.
(8) Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study
(9) Males who have donated over 400 mL of blood and/or blood component within the last three months prior to the current study
(10) Females who have donated over 400 mL of blood and/or blood component within the last four months prior to the current study
(11) Males whose total blood collection volume exceeding 1200 mL
within the last twelve months prior to the current study (include the blood collection volume of the current study)
(12) Females whose total blood collection volume exceeding 800 mL
within the last twelve months prior to the current study (include the blood collection volume of the current study)
(13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sakano |
Organization
CPCC Company, Limited
Division name
Department of Parmaceutical Medical Business Sciences
Zip code
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Numa |
Organization
CPCC Company, Limited
Division name
Sales department
Zip code
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
| 2017 | Year | 06 | Month | 21 | 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
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | 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
| 2017 | Year | 06 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031820
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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