A randomized placebo-controlled trial for evaluating effects of consumption of perilla fruit (Nga-keemon) oil-added soybean milk on health outcomes and blood biomarkers among healthy subjects

Perilla frutescens var. keemon fruit oil-fortified soybean milk intake alters levels of serum triglycerides and antioxidant status, and influences phagocytotic activity among healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11403535

Enrollment

196

Registered

2022-03-26

Start date

2015-02-10

Completion date

Unknown

Last updated

2023-06-05

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

Conditions

Comparative effects on consumption of perilla fruit oil-fortified soybean milk and black sesamin-fortified soybean milk in healthy adult subjects Not Applicable

Interventions

In this clinical trial, the block randomization method was employed in order to randomise healthy subjects (n = 192, male and female) who were then divided into four groups (n = 48 each): Group 1 was

bp values of < 0.05 when compared with the baseline (D0) in the sa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Not allergic to soybeans or perilla nutlets 2. Not currently participating in any vitamin, supplementary food, or any other controlled diet programs 3. Aged 20-60 years old

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Systolic/diastolic blood pressure measured using an aneroid sphygmomanometer with a cuff at the baseline (day 0) and at the end of the study (day 30) 2. Hematological parameters measured using an automated cell counter/analyzer (Beckman Coulter Life Sciences, Indianapolis, NJ, USA) according to the manufacturer’s instructions on days 0 and 30 3. Blood biochemical parameters, including blood urea nitrogen (BUN), creatinine (CRE), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total cholesterol (TC), triglycerides (TG), high-density lipoprotein-cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C), analyzed using an automated clinical chemistry analyzer (Randox Laboratories Limited, County Antrim, UK) according to the manufacturer’s instructions on days 0 and 30 4. Phagocytotic activity in the blood measured according to established methods on days 0 and 30 5. ROS in RBC detected using the dichlorofluorescein diacetate/flow cytometry method on days 0 and 30 6. Serum thiobarbituric acid-reactive substance (TBARS) concentrations measured using the colorimetric method on days 0 and 30 7. Superoxide dismutase (SOD) activity determined using Dojindo’s highly water-soluble tetrazolium salt with WST-1 as an electron acceptor according to the procedure described by the manufacturer on days 0 and 30 8. Serum reduced glutathione (GSH) concentration determined based on the non-enzymatic reduction of 5,5’-dithiobis(2-nitrobenzoic acid) substrate to yellow-colored 5-thio-2-nitrobenzoic acid product on days 0 and 30 9. Total antioxidant capacity (TAC) value in the serum measured using 2,2-diphenyl-1-picryl-hydrazyl (DPPH) radical scavenging assay on days 0 and 30	—

Measure

Time frame

1. Systolic/diastolic blood pressure measured using an aneroid sphygmomanometer with a cuff at the baseline (day 0) and at the end of the study (day 30) 2. Hematological parameters measured using an automated cell counter/analyzer (Beckman Coulter Life Sciences, Indianapolis, NJ, USA) according to the manufacturer’s instructions on days 0 and 30 3. Blood biochemical parameters, including blood urea nitrogen (BUN), creatinine (CRE), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total cholesterol (TC), triglycerides (TG), high-density lipoprotein-cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C), analyzed using an automated clinical chemistry analyzer (Randox Laboratories Limited, County Antrim, UK) according to the manufacturer’s instructions on days 0 and 30 4. Phagocytotic activity in the blood measured according to established methods on days 0 and 30 5. ROS in RBC detected using the dichlorofluorescein diacetate/flow cytometry method on days 0 and 30 6. Serum thiobarbituric acid-reactive substance (TBARS) concentrations measured using the colorimetric method on days 0 and 30 7. Superoxide dismutase (SOD) activity determined using Dojindo’s highly water-soluble tetrazolium salt with WST-1 as an electron acceptor according to the procedure described by the manufacturer on days 0 and 30 8. Serum reduced glutathione (GSH) concentration determined based on the non-enzymatic reduction of 5,5’-dithiobis(2-nitrobenzoic acid) substrate to yellow-colored 5-thio-2-nitrobenzoic acid product on days 0 and 30 9. Total antioxidant capacity (TAC) value in the serum measured using 2,2-diphenyl-1-picryl-hydrazyl (DPPH) radical scavenging assay on days 0 and 30

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026