NIPH Clinical Trials Search

Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy subjects
Date of first enrollment	2017/09/13
Target sample size	60
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	High dose Portulaca Oleracea yeast extract Subjects take 3 capsules after supper every day for 28 days. Low dose Portulaca Oleracea yeast extract Subjects take 3 capsules after supper every day for 28 days. Dextrin Subjects take 3 capsules after supper every day for 28 days.

Outcome(s)

Primary Outcome	Intestinal mucin Intestinal sIgA
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	19years-old
Age maximum	37years-old
Gender	Male and Female
Include criteria
Exclude criteria	Person who is in the hospital or medication under the basic disease (diabetes, heart disease, kidney disease, liver disease, hyponatremia, difficulty to treat hypertension, etc.) Person undergoing medication treatment. Extremely brief sleep (less than 5 hours a day) and long sleeping people (more than 10 hours a day). Those who live in the opposite direction day and night due to work or part-time job. Person who is undergoing excessive physical and mental stress. Individuals receiving treatment for autoimmune diseases, chronic inflammatory diseases, allergic diseases, cancer. Those who are accustomed to excessive smoking and excessive alcohol intake, and those with extremely irregular eating habits. Persons who have remarkable abnormalities in blood pressure, blood test, urinalysis, etc. Persons who overdosed the following items over ordinary meals. Caffeine (green tea, coffee), alcohol, carbohydrates, lipids, spices, capsaicin (foods rich in curry and chilies), lactic acid bacteria (yogurt), dietary fiber (brown rice, barley, soybean, burdock, carrots, sesame, potatoes, Seaweeds). Those who have undergone major surgery on the digestive system such as gastrectomy, gastrointestinal suture, intestinal resection. 400 mL blood donation within 12 weeks of starting the experiment, 200 mL blood donation within 4 weeks, donor ingredient donation within 2 weeks.