UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036241 |
|---|---|
| Receipt number | R000041280 |
| 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 | 2019/03/18 |
| Last modified on | 2021/06/03 14:40:15 |
* 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
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.
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.
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
serum triglyceride
*Measure at before ingestion and 1, 2, 3, 4, 5, 6 hours after 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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing test food + high fat meal, single ingestion [Wash out for 1 week] Food not containing test food + high fat meal, single ingestion
Interventions/Control_2
Food not containing test food + high fat meal, single ingestion [Wash out for 1 week] Food containing test food + high fat meal, 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, aged 20 - 65 years old.
2) Individuals whose fasting serum triglyceride level is less than 150 mg/dL
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Individuals whose fasting serum triglyceride level is greater than or equal to 150 mg/dL.
2) A medical history of malignant tumor, heart failure or myocardial infarction.
3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4) Subjects who currently on medications (including herbal medicines)
5) Subjects who are allergic to medicines and/or the test food related products.
6) Subjects with irregular life rhythms such as shift workers, irregular eating habits.
7) Subjects who are pregnant, breast-feeding, or planning to get pregnant.
8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial.
9) Subjects who are considered as ineligible to participate in the study by the physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Makishima |
Organization
Allegro Inc.
Division name
Clinical trial promotion department
Zip code
151-0051
Address
4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
TEL
03-5363-6821
y-maki@bml.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Kase |
Organization
Allegro Inc.
Division name
Clinical trial promotion department
Zip code
151-0051
Address
4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo
TEL
03-5363-6821
Homepage URL
f-kase@bml.co.jp
Sponsor or person
Institute
Allegro Inc.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
MC Food Specialties Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tomisaka Clinic
Address
1-33-9, Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-2662
info@tomisaka.or.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
| 2019 | Year | 03 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041280
