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.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014427

Enrollment

120

Registered

2014-06-30

Start date

2014-09-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
triglyceride	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactDir. Prof. Jun Nishihira, M.D.

Hokkaido Information University Health Information Science Center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026