A Study on Lipid Improvement Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on Lipid Improvement Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on Lipid Improvement Effect of Food Containing Plant Extract

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043673

Enrollment

Registered

2021-03-19

Start date

2021-03-22

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

None listed

Interventions

Foods containing plant extract, 12 weeks consumption Foods not containing plant extract, 12 weeks consumption

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose LDL-cholesterol levels are 139 mg/dL or less, or triglyceride levels are 149 mg/dL or less by the screening tests. (3) Subjects whose HDL-cholesterol levels are 40 mg/dL or over. (4) Subjects whose BMI are under 30. (5) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism. (2) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism. (4) Subjects with tendency of diarrhea or who have diarrhea within 2 weeks before the screening test. (5) Subjects who are shift workers and/or night-shift workers. (6) Subjects who were pregnant or planned to become pregnant or breastfeed during the study period. (7) Subjects who have been diagnosed as familial hyperlipidemia. (8) Subjects with a history of and/or current drug addiction and/or alcoholism. (9) Subjects who were planning to participate and/or had participated in other clinical studies within the month prior to the commencement of the current study. (10) Subjects who were judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
LDL-cholesterol Triglyceride	—

Secondary

Measure	Time frame
Other lipid metabolism markers Body fat and liver function markers	—

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results