UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035337 |
|---|---|
| Receipt number | R000040262 |
| Scientific Title | A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2019/01/18 |
| Last modified on | 2019/06/24 11:49:15 |
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Basic information
Public title
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.
-Randomised double-blind placebo-controlled trial
Acronym
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.
-Randomised double-blind placebo-controlled trial
Scientific Title
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.
-Randomised double-blind placebo-controlled trial
Scientific Title:Acronym
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.
-Randomised double-blind placebo-controlled trial
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 intake on the suppression of the elevation of postprandial serum triglyceride after ingesting high fat meal.
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
Time course of serum RLP-cholesterol level and AUC (area under the curve)(0-6hrs)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test participants intake one package of test food dissolved in 180ml water 15 min before consuming high fat meal.
Interventions/Control_2
Test participants intake one package of control food dissolved in 180ml water 15 min before consuming high fat meal.
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 aged 20 to 64 years old when informed consent and body mass index (BMI) is included between 18.5 to less than 30
(2)Individuals whose fasting serum triglyceride level at the time of screening is 150mg/dL or less
(3) Individuals who do not drink large amount of alcohol habitually
(4) Individuals who are judged that not suffering from a disease.
(5)Individuals giving written informed consent
Key exclusion criteria
(1)Individuals who use oral medication affecting lipid metabolism
(2)Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting lipid metabolism
(3)Individuals who are suffered from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder
(4)Individuals who have a chronic disease and use medicines continuously
(5)Individuals who are diagnosed as severe anemia and not suitable for frequent collection of blood
(6)Individuals who had an onset diarrhea within one week from the date of screening, and who is prone to diarrhea always
(7)Individuals who are diagnosed as familial hyperlipidemia
(8)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(9)Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
niho-jimucho@well-sleep.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings Co., Ltd.
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
| 2019 | Year | 01 | Month | 18 | 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 | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040262
