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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014427
Receipt No. R000016791
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.
Date of disclosure of the study information 2014/06/30
Last modified on 2016/10/28

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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://upload.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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