The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.

The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial. - The study of living body control function by "Koiaona".

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028707

Enrollment

Registered

2018-02-01

Start date

2018-03-15

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

N/A(healthy adults)

Interventions

Duration: 12 weeks Test material:&quot

Koiaona &quot

powder Dose: Take one package, two times a day Administration: Take one package before breakfast and dinner Duration: 12 weeks Test material:Placebo Dose: Take one package, two times a day A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)20yrs<=age<=65yrs 2)Male and Female 3)Outpatients 4)120mg/dl<=LDL-Cholesterol<=159mg/dl 5)Those who are able to take the test foods during 3 months. 6)Those who don't change living habits such as exercise, diet, sleeping etc during the study period 7)consent document

Exclusion criteria

Exclusion criteria: 1) Smokers 2)Those who are taking drugs for disease treatment 3) serious heart disease [heart failure, myocardial infarction, myocarditis, etc.] liver disease [liver failure symptoms (fulminant hepatitis ),patients with cirrhosis of the liver, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), uremia, merged, etc. hydronephrosis] 4) Those who have participated in other clinical trials within before consent get one month, and those who are currently participating in other clinical trials. 5) At the physician's judgment, who it is determined that there is a possibility that either increased risk to the subject, or sufficient data not obtained 6) Those who take antibiotics within before consent get one month 7) Those who currently take health foods

Design outcomes

Primary

Measure	Time frame
Biomarkers of blood lipids such as LDL-C, HDL-C and TG will be measured as primary endpoint. The changes will be compared within each group and between the treatment groups.	—

Secondary

Measure	Time frame
As secondary endpoints, following items will be evaluated; blood examination involving oxidative stress and special items such as s-LOX1, carotenoid, inflammation, mitochondrial function index, urinalysis, physiological parameters, variety and ratio of bacteria in stool and meal nourishment.	—

Countries

Japan

Contacts

Public ContactTomohisa Takagi

Kyoto Prefectural University of Medicine Department of Gastroenterology and Hepatology

takatomo@koto.kpu-m.ac.jp075-251-5508

Outcome results

None listed

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

The study to investigate the living body control function of &quot;Koiaona&quot;, which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.