UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014427 |
|---|---|
| Receipt number | 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 09:03:55 |
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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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
