Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000033427
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-18
• Study Completion: 2019-01-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily *Particularly taking food/beverage effective in lowering blood sugar in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplement *Particularly taking antihypertensive drugs in daily 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Fasting blood glucose level * Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change.

Secondary Outcome Measures

Name	Time	Method
1. Hemoglobin A1c (HbA1c) level 2. Serum glycoalbumin level 3. Serum insulin level 4. Plasma pentosidine 5. Vascular age 6. Vascular age score 7. Value of Schirmer's test (right eye, left eye, the average in both eyes, dominant eye, and non-dominant eye) *1-7 Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change. *5,6 Measure the items by Medical Analyzer. *7 Measure the item by Schirmer tear test strips. <Safety evaluation items> 1. Physical examination 2. Urinalysis 3. Blood test *1-3 Measure the values at 8 and 12 weeks after consumption and calculate the amount of change. *2 Measure the values at 8 and 12 weeks after consumption.