UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045632 |
|---|---|
| Receipt number | R000052051 |
| Scientific Title | A clinical study for evaluating of the suppressive effect of a supplement containing complex ingredients on the elevation of postprandial serum triglyceride. |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/10/05 18:52:17 |
* 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 of the suppressive effect of a supplement containing complex ingredients on the elevation of serum triglyceride.
Acronym
A clinical study for evaluating of the suppressive effect of a supplement containing complex ingredients on the elevation of serum triglyceride.
Scientific Title
A clinical study for evaluating of the suppressive effect of a supplement containing complex ingredients on the elevation of postprandial serum triglyceride.
Scientific Title:Acronym
A clinical study for evaluating of the suppressive effect of a supplement containing complex ingredients on the elevation of postprandial serum triglyceride.
Region
| Japan |
Condition
Condition
Healthy subjects with normal to slightly higher fasting serum triglyceride levels
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the supplement containing complex ingredients on postprandial serum triglyceride (TG) and the safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the area under the curve of postprandial serum triglyceride level when placebo and test food are consumed
Key secondary outcomes
The comparison of the area under the curve and the level at each measuring point of Remnant-like particles-cholesterol and chylomicron-TG when placebo and test food are consumed.
The comparison of the level at each measuring point of postprandial serum triglyceride when placebo and test food are consumed.
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
single ingestion of the placebo food - washout period (6 days and more) - single ingestion of the test food
Interventions/Control_2
single ingestion of the test food - washout period (6 days and more) - single ingestion of the placebo food
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 between the ages of 20 and 64 years old at the time of obtaining consent to participate in the study.
2. Healthy subjects with normal to slightly higher fasting serum triglyceride levels at pre-screening, and whose time courses of serum TG after loading dietary food resemble
each other at 1st and 2nd screening.
3. Subjects available at every designated visit.
4. Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
1. Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
2. Subjects with a surgical history of digestive system (except appendicectom).
3. Subjects currently under treatment with chronic diseases.
4. Subjects with food allergies to the food ingredients used in the test.
5. Subjects who are pregnant or intend to become pregnant during the study or are lactating.
6. Subjects who are lactose intolerant or are susceptible to gastrointestinal symptoms of high-fat foods.
7. Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) and excessive smokers (smoke more than 20 cigarettes per day).
8. Subjects who always take drugs or supplements which claim the suppressive absorption of sugar or lipid or reduction of triglyceride, etc.
9. Subjects who participate in other clinical trial.
10. Subjects who may feel unwell or deteriorate due to repeated blood collection.
11. Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study.
12. Subjects who do not take breakfast.
13. Subjects who work from 22:00 to 6:00 (shift worker, night- shift worker, etc.)
14. Subject who cannot consume foods whose origin is not clearly indicated due to religious or other reasons.
15. Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kunishige |
Organization
Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name
Internal medicine
Zip code
004-0004
Address
2-1-30, Atubetsuhigashi4jo, Atubetsu-ku, Sapporo, Hokkaido, Japan
TEL
011-898-2151
esashika@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, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujifilm 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
Medical corporation Hokubukai beauty hill hospital ethics review committee
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel
011-882-0111
matsuda@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | 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
| 2021 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052051
