UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050594 |
|---|---|
| Receipt number | R000057575 |
| Scientific Title | The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial- |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2024/03/11 09:54:57 |
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Basic information
Public title
The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-
Acronym
The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-
Scientific Title
The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-
Scientific Title:Acronym
The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-
Region
| Japan |
Condition
Condition
Healthy subjects with normal level or slightly higher than normal level of fasting serum triglyceride
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a supplement containing complex ingredients on postprandial serum triglyceride (TG) and its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of area under the concentration curve (AUC) in the change of triglyceride levels between groups after single ingestion.
Key secondary outcomes
Comparison of area under the concentration curve (AUC) in the triglyceride levels as is between groups after single ingestion.
Between group comparison of triglyceride levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion.
Between group comparison of remnant-like lipoprotein cholesterol levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion as well as comparison for those for the area under the concentration curve (AUC).
Effects on the intestinal microflora after 7 days consecutive ingestion of test food.
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
Ingestion of the placebo food(7 days) - washout period (3 weeks or more) - ingestion of the test food(7 days)
Interventions/Control_2
Ingestion of the test food (7 days) - washout period (3 weeks or more) - ingestion of the placebo food(7 days)
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 giving consent to participate in the study.
(2) Subjects whose fasting triglyceride level is less than 200 mg/dL before lipid load at screening.
(3) Subjects who can be available to the test site on the visit dates.
(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 history of hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious illness.
(2) Subjects with a surgical history of digestive system (except appendicectomy).
(3) Subjects with chronic diseases under treatment.
(4) Subjects with food allergies to the food ingredients used in the study.
(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 high-fat foods to show gastrointestinal symptoms.
(7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) or excessive smokers (smoke more than 20 cigarettes per day).
(8) Subjects who always take drugs or supplements which claim the effects such as 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 have a habit of skipping meals.
(13) Subjects who work from 22:00 to 6:00 (shift workers, late night workers, etc., including part-time workers)
(14) Subjects who due to religious or other reasons need to avoid consuming foods whose origin is not clearly indicated.
(15) Subjects judged as unsuitable for this study by the investigator with other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kunishige |
Organization
Medical Corporation Shoureikan Shin-Sapporo Seiryou Hospital
Division name
Internal medicine
Zip code
004-0004
Address
2-1-30, Atubetsuhigashi4jo, Atubetsu-ku, Sapporo, Hokkaido, Japan
TEL
011-898-2151
ishikawa@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 Shin-Sapporo 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 UtsukushigaokaHospital Ethics Review Committee
Address
No. 61, Maeda, 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
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057575
