Clinical study of Sakurajima Daikon

JRCT ID: jRCTs071210142

Registered date:30/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metabolic syndrome
• Date of first enrollment: 13/06/2022
• Target sample size: 21
• Study type: Interventional

Intervention(s)

1) Sakurajima Daikon Powder Period:
Sakurajima Daikon Powder(Take Yakuhin product, 5g/1pack, 2packs per day)
2packs per day(10g), Take one or two divided doses.
2) Aokubi Daikon Powder Period:
Aokubi Daikon Power (Take Yakuhin product, 5g/1pack, 2packs per day)
2packs per day(10g), Take one or two divided doses.
3) Normal diet Period:
Do not change the diet before the start of the study as much as possible.

Outcome(s)

• Primary Outcome: %FMD at 14 days after the start of feeding

Secondary Outcome

1) Trigonelline value at 14 days after the start of feeding.
2) Lipid profile value at 14 days after the start of feeding.
- Total cholesterol
- Low density lipoprotein cholesterol
- High density lipoprotein cholesterol
- Triglyceride
3) Measured value at 14 days after the start of feeding.
- Urine NOx
- Urine 8-OhdG/Urine Creatinine ratio
4) Systolic blood pressure at 14 days after the start of feeding.
5) Diastolic blood pressure at 14 days after the start of feeding.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients providing written informed and consent to participate in the study
2) Aged >= 18 years (irrespective of sex)
3) Patients with Metabolic syndrome

Exclude criteria

1) Patients with active or prior malignancy, heart failure, myocardial infarction.
2) Patients undergoing treatment for the following chronic diseases(excluded hypertension, dyslipidemia and diabetes).
Arrhythmia, Liver disorder*, Renal disorder*, Cerebrovascular disorder, Rheumatoid arthritis, and other chronic diseases.
* The following definitions shall be used for Liver and Renal disorder.
- Liver disorder: AST and ALT are more than 3 times the upper limit of the (facility) reference value.
- Renal disorder: Serum creatine >= 2.4 mg/dL (men), >= 2.0 mg/dL (women).
3) Patients with allergies (to medicines and test food related foods).
4) Patients with pregnancy, on breast-feeding or who wish to become pregnant during trial.
5) Current smoker in the 3 months prior to the date consent was obtained.
6) Patients registered in other clinical trials presently or within 3 months before acquisition consent of this trial.
7) Patients whom physician in charge considered inappropriate for the study.

Related Information

• Primary Sponsor: Ohishi Mitsuru
• Source(s) of Monetary Support: Takeyakuhin Corporation.,JUFUKU SANGYO Co., Ltd.