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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026135
Receipt No. R000029452
Scientific Title A clinical study for evaluating the effect of a complex food on the suppression of the elevation of postprandial serum triglyceride
Date of disclosure of the study information 2018/03/30
Last modified on 2019/03/05

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Basic information
Public title A clinical study for evaluating the effect of a complex food on the suppression of the elevation of postprandial serum triglyceride
Acronym A clinical study for evaluating the effect of a complex food on the suppression of the elevation of postprandial serum triglyceride
Scientific Title A clinical study for evaluating the effect of a complex food on the suppression of the elevation of postprandial serum triglyceride
Scientific Title:Acronym A clinical study for evaluating the effect of a complex food on the suppression of the elevation of postprandial serum triglyceride
Region
Japan

Condition
Condition Slightly higher fasting serum triglyceride level (from 120 to no more than 200 mg/dL)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of a complex food on the suppression of the elevation of postprandial serum triglyceride as a primary endpoint.
To evaluate the safety of the complex food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time course of serum triglyceride level and AUC 0-6 for actual measured values as well as amount of changed values after intake of dietary fat.
Key secondary outcomes Time course of serum RLP-cholesterol level and AUC 0-6 for actual measured values and amount of changed values after intake of dietary fat.
Assessment of safety(subjective and objective symptoms and blood biochemistry).

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 single ingestion of a placebo food - washout period (6 days or more) - single ingestion of a test food
Interventions/Control_2 single ingestion of a test food - washout period (6 days or more) - single ingestion of a 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)Healthy Japanese males and females from 20 to 64 years of age when consented.
(2)Subjects whose fasting serum triglyceride levels are less than 150 mg/dL. Most of them desirably have triglyceride level of 120 - 149 mg/dL.
(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 appendicectomy)
(3)Subjects with a history of a previous drug or food allergy.
(4)Subjects currently under treatment with chronic diseases.
(5)Subjects who are pregnant or intend to become pregnant during the study or are lactating.
(6)Subjects who are lactose intolerant or sensitive to fatty diet to show gastrointestinal symptoms.
(7)Subjects who take excessive alcohol (equivalent to 540 mL of Japanese sake or more) for 5 days or more per week.
(8)Subjects who 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 have a history of feeling ill or unwell during or after blood drawing.
(11)Subjects who have donated over 200 mL of blood within the last one month prior to this study or expect to donate the same during the study.
(12)Subjects with extremely irregular diet (shift worker, night-shift worker, etc.)
(13)Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Takano
Organization Medical Corporation Hokubukai
Division name Utsukushigaoka Hospital
Zip code
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Wakimoto
Organization Medical Corporation Hokubukai
Division name Utsukushigaoka Hospital
Zip code
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Homepage URL
Email wakimoto@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 30 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
In the stratified group, there was a tendency to suppress the elevation of postprandial serum triglyceride by ingestion of the complex food.
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
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 14 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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