Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.

Not Applicable

• Conditions: one (Healthy adults)

• Registration Number: JPRN-UMIN000027309
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (2) Individuals who have chronic diseases and use medicines continuously. (3) Individuals with excessive alcohol-drinking behaviors (Maximum daily quantity: Approximately 20 g of pure alcohol per day, for example, beer 1 bottle 500 mL, whiskey double 1 cup 60 mL, or wine approximately 1.5 cups 180 mL, respectively) . (4) Individuals who cannot stop drinking for two days until the screening and each checkup. (5) Individuals having food allergy. (6) Individuals who have a medical history of hay fever. (7) Individuals who have a medical history of diseases affecting digestion and absorption. (8) Individuals who have tendency to get diarrhea by eating dairy product. (9) Individuals who have a history of irritable bowel syndrome and Crohns disease. (10) Individuals who are judged as unsuitable for the study based on the results of blood test. (11) Individuals who have under treatment or a history of drug addiction and/or alcoholism. (12) Individuals who are participating or willing to participate in other clinical trials with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products. (13) Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. (14) Individuals who refuse to answer their biological sex. (15) Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods. (16) Individuals who are judged unsuitable for this study by the investigator for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified