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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028525
Receipt No. R000032641
Scientific Title Effects of functional foods on the blood cholesterol level -A randomized, double-blind, placebo-controlled, parallel-group comparative study-
Date of disclosure of the study information 2017/08/03
Last modified on 2018/01/29

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Basic information
Public title Effects of functional foods on the blood cholesterol level
-A randomized, double-blind, placebo-controlled, parallel-group comparative study-
Acronym Effects of functional foods on the blood cholesterol level
Scientific Title Effects of functional foods on the blood cholesterol level
-A randomized, double-blind, placebo-controlled, parallel-group comparative study-
Scientific Title:Acronym Effects of functional foods on the blood cholesterol level
Region
Japan

Condition
Condition hypercholesterolemia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of functional foods on the blood cholesterol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood LDL- cholesterol level
Key secondary outcomes blood total- cholesterol level
blood non-HDL- cholesterol level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Food1(Intake priod:12 weeks)
Interventions/Control_2 Food2(Intake priod:12 weeks)
Interventions/Control_3 Placebo(Intake priod:12 weeks)
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)20 to 75 years at the time of informed consent and possible to visit.
2)Japanese males and females.
3)LDL-Cho >=140 mg/dl and <200 mg/dl.
Key exclusion criteria 1)Subjects who is taking the following medications within 3 months, or who is scheduled to take medication after informed consent to participate in this examination.
Fibrate-based medicine (bezafibrate etc), nicotinic acid, azole antifungal drug (itraconazole etc), macrolide antibiotics(erythromycin etc), coumarin-based anticoagulants(warfarin), antacid(magnesium hydroxide, aluminium hydroxide), lopinavir and ritonavir combination drug,Simeprevir, eltrombopag.
2)Subjects using steroidal and non-steroidal medicines (internal medicine / topical medicine).
3)Subjects who regularly use chemicals (orlistat (Xenical, Arai )etc) affecting fat absorption.
4)Subjects who previous or present serious disease such kidney, liver, circulatory system, benign neoplasm,mental, dementing disorder.
5)Subjects who are alcoholics or previous.
6)Subjects with hypothyroidism, patients with hereditary muscle disease (muscular dystrophy etc) or their family history, or those with a history of drug-induced myopathy.
7)Subjects who are receiving medication in diabetic patients or hypertensive patients.
8)Subjects who have allergy related to the study foods.
9)Subjects who using health foods (supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol.
10)Subjects who are participating within 3 months or planning to participate in other clinical study.
11)Subjects who are pregnant or breast-feeding.
12)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
Target sample size 75

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Yamato
Organization Medical Corporation Kouwakai Kouwa Clinic
Division name Director
Zip code
Address 6-33-17, komagome, toshima-ku, Tokyo, Japan
TEL 03-3917-8105
Email info@kouwakai.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masao Matsuoka
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Oekkusu Bldg. 10th Fl., 5-31-19 Shiba,Minato-ku,108-0014,Japan
TEL 03-3431-1216
Homepage URL
Email matsuoka@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization FANCL 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 08 Month 03 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 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 17 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 08 Month 03 Day
Last modified on
2018 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032641

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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