Unique ID issued by UMIN | UMIN000014427 |
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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 |
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.
Effects of enriched beta-conglycinin soy based processed food on dyslipidemia.
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.
Effects of enriched beta-conglycinin soy based processed food on dyslipidemia.
Japan |
Dyslipidemia
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase III
triglyceride
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Enriched beta-conglycinin soy based processed food, ingested 40 g/day for 12 weeks.
Soy based placebo processed food, ingested 40 g/day for 12 weeks.
30 | years-old | <= |
70 | years-old | > |
Male and Female
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.
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.
120
1st name | |
Middle name | |
Last name | Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Ministry of Agriculture, Forestry and Fisheries
Japanese Governmental office
Japan
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.
NO
北海道情報大学 保健センター(北海道)
2014 | Year | 06 | Month | 30 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/27529274
Completed
2014 | Year | 06 | Month | 23 | Day |
2014 | Year | 09 | Month | 05 | Day |
2014 | Year | 12 | Month | 21 | Day |
2015 | Year | 04 | Month | 03 | Day |
2015 | Year | 04 | Month | 10 | Day |
2016 | Year | 02 | Month | 05 | Day |
2014 | Year | 06 | Month | 30 | Day |
2016 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016791
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