UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042359 |
|---|---|
| Receipt number | R000048321 |
| Scientific Title | Effect of a Functional Food for Postprandial Triglyceride. |
| Date of disclosure of the study information | 2020/11/06 |
| Last modified on | 2021/06/01 09:46:23 |
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Basic information
Public title
Effect of a Functional Food for Postprandial Triglyceride.
Acronym
Effect of a Functional Food for Postprandial Triglyceride.
Scientific Title
Effect of a Functional Food for Postprandial Triglyceride.
Scientific Title:Acronym
Effect of a Functional Food for Postprandial Triglyceride.
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of a functional food for postprandial triglyceride.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Efficacy evaluation (changes, increase and decrease, Cmax, delta Cmaxm AUC and iAUC of TG and NEFA(1); blood viscosity and lipid composition analysis(2)).
(1): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet).
(2): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
Key secondary outcomes
*Safety
[1]Blood pressure, pulsation(1).
[2]Weight, body fat percentage, BMI(2).
[3]Doctor's questions(1).
[4]Subject's diary(3).
*Other indexes
[1]Hematologic test(4).
[2]Blood biochemical test(2).
[3]Urine analysis(4).
[4]Anti-Aging QOL Common Questionnaire(2).
(1):Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
(2):Screening; Week 0, Week 4 (before ingestion of a challenge diet).
(3):From two days before ingestion of a challenge diet in observation period I to one day before ingestion of a challengediet in Week 4.
(4):Screening.
(5): Week 0, Week 4 (before ingestion of a challenge diet).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
[1]Oral Fat Tolerance Test (1 time).
[2]Oral intake of the tes food (6 tablets in a day; 4 weeks).
[3]Oral Fat Tolerance Test (1 time).
Interventions/Control_2
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]Japanese males and females aged 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals whose triglyceride level is high-normal (120-149 mg/dL) or who are mild hyperlipemia
(150-199mg/dL).
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions.
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[5]Individuals who have digestive organ disease (disease of an appendix is removed).
[6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females).
[7]Individuals whose BMI is over 30kg/m2.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals with serious anemia.
[10]Individuals who are difficult to conduct blood collections over time.
[11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies.
[12]Individuals who cannot intake every diet the day before the inspection day or every loading food.
[13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day.
[14]Individuals whose life style will change during the test period (ex. travel for a long time).
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period.
[16]Individuals who are or are possibly pregnant, or are lactating.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name
Head
Zip code
169-0072
Address
3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL
+81-3-6233-8583
h.kondo@meiseikai-cl.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 06 | 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
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048321
