UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Katsuhisa Sakano
Organization	CPCC Company, Limited
Division name	Department of Parmaceutical Medical Business Sciences
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Masanori Numa
Organization	CPCC Company, Limited
Division name	Sales department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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