UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027767
Receipt No. R000031820
Scientific Title A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study)
Date of disclosure of the study information 2017/06/21
Last modified on 2017/12/14

* 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 seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study)
Acronym A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride.
Scientific Title A clinical study for evaluating the efficacy of seasoning containing functional ingredients on the suppression of the elevation of postprandial serum triglyceride. (Randomised, placebo controlled crossover study)
Scientific Title:Acronym A clinical study for evaluating the efficacy of seasoning containing functional ingredients 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 on the suppression of the elevation of postprandial serum triglyceride.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time course of serum triglyceride level and AUC (area under the curve)(0-6hrs)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Seasoning containing functional ingredients, vegetable (1 day)
Interventions/Control_2 Seasoning not containing functional ingredients, vegetable
Interventions/Control_3 No intervention
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
60 years-old >=
Gender Male and Female
Key inclusion criteria (1) Healthy individuals aged 20 to 60 years old
(2) Individuals whose fasting serum triglyceride levels are from 120 mg/dL to 199 mg/dL.(3) Individuals giving written informed consent
Key exclusion criteria (1) Individuals who use oral medication, supplements and/or functional foods affecting lipid metabolism
(2) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(3) Individuals who are suffered from or under treatment of serious disease (e.g., heart disease, liver disease, kidney disease, and/or digestive disease)
(4) Individuals who are under treatment of alcohol dependence
(5) Individuals who are extremely irregular in eating habits
(6) Individuals who declare the allergy symptoms against drugs and/or foods
(7) Individuals who are participating in other clinical trials of drugs or health food, who participated in the last 4 weeks, or who are willing to participate after giving the informed consent.
(8) Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study
(9) Males who have donated over 400 mL of blood and/or blood component within the last three months prior to the current study
(10) Females who have donated over 400 mL of blood and/or blood component within the last four months prior to the current study
(11) Males whose total blood collection volume exceeding 1200 mL
within the last twelve months prior to the current study (include the blood collection volume of the current study)
(12) Females whose total blood collection volume exceeding 800 mL
within the last twelve months prior to the current study (include the blood collection volume of the current study)
(13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company, Limited
Division name Department of Parmaceutical Medical Business Sciences
Zip code
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL 03-5297-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Numa
Organization CPCC Company, Limited
Division name Sales department
Zip code
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company, Limited
Institute
Department

Funding Source
Organization Kewpie 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
2017 Year 06 Month 21 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
2017 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 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 06 Month 15 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.