UMIN-CTR Clinical Trial

Basic information
Public title	Placebo controlled, double bind, randomized, parallel group clinical trial to study the effects of continuous ingestion of enriched beta-conglycinin soy based processed food on dyslipidemia.
Acronym	Effects of enriched beta-conglycinin soy based processed food on dyslipidemia.
Scientific Title	Placebo controlled, double bind, randomized, parallel group clinical trial to study the effects of continuous ingestion of enriched beta-conglycinin soy based processed food on dyslipidemia.
Scientific Title:Acronym	Effects of enriched beta-conglycinin soy based processed food on dyslipidemia.
Region	Japan

Condition
Condition	Dyslipidemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the improvement of lipid metabolism in dyslipidemia by ingesting processed soy food enriched in beta-conglycinin (containing 5g/day of beta-conglycinin) in a 12 week randomized, double-blind, placebo-controlled study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	triglyceride
Key secondary outcomes	T-Cho, LDL-Cho, HDL-Cho, FBG, HbA1c, Insulin, Adiponectin, hs-CRP, Active-GLP1 (pre intervention, post intervention), body composition (weight, BMI, body fat percentage)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Enriched beta-conglycinin soy based processed food, ingested 40 g/day for 12 weeks.
Interventions/Control_2	Soy based placebo processed food, ingested 40 g/day for 12 weeks.
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	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects who have fasting triglyceride levels between the range of 55 mg/dl to 260 mg/dl. 2.Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria	1.Subjects who use medication for chronic ailments (especially cancer, diseases related to: liver, kidney, heart, digestive system disorder, diabetes, dyslipidemia, stress, high blood pressure, mental illness etc.) 2.Subjects who have serious disease(cerebrovascular, heart, liver, kidney, gastrointestinal, infectious diseases that requires notification) 3.Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc. 4.Subjects having a family history of hypercholesterolemia 5.Subjects who take drugs affecting serum lipids (EPA formulation, statin, fibrates, ezetimibe, steroids, thyroid drugs, functional food / nutraceuticals, health supplements (EPA, DHA, medium chain triglycerides, plant sterol, sesamen, turmeric, polyphenols, dietary fiber 6.Subjects with frequent complaints of post-menopausal symptoms 7.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data 8.Subjects with serious anemia 9.Subjects with a history of allergy to medicine and food, especially soybean 10.Heavy smokers or alcohol addicts or subjects with irregular lifestyle 11. Subjects who donated 400ml whole blood within past 12 weeks, or 200ml whole blood within past 4 weeks, or plasma or platelets within past 2 weeks prior to this study 12.Subjects who are pregnant or under lactation, or expected to get pregnant during the study 13.Subjects who are currently participating in or who had participated in other clinical trials within the last one month prior to this study 14.Subjects who are judged ineligible by our physician.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Prof. Jun Nishihira, M.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code
Address	59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Dir. Prof. Jun Nishihira, M.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code
Address	59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kinki University, Faculty of Agriculture National Agriculture and Food Research Organization Nagano Research Center of Vegetable and Floricultural Science Asahimatsu Foods Co., Ltd. Minami Sangyo Co., Ltd. Maruyanagi Co., Ltd.
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	北海道情報大学　保健センター(北海道)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/27529274
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	2014 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date	2014 Year 12 Month 21 Day
Date of closure to data entry	2015 Year 04 Month 03 Day
Date trial data considered complete	2015 Year 04 Month 10 Day
Date analysis concluded	2016 Year 02 Month 05 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 30 Day
Last modified on	2016 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016791

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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