N/A (healthy adults)
Conditions
Interventions
[1]Oral ingestion of a test food (1 time). [2]Rice intake. [3]Observation. [4]Washout (over 6 days) [5]Oral ingestion of a placebo food (4g in one time, 1 time). [6]Not intaking rice. [7]Observa
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-59 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals who are anxious about high fasting blood glucose level. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are or are under treatment or have a history of abnormal glucose tolerance, mental disabilities, sleep disorder, hypertension, diabetes, fat metabolism or the other serious dysfunctions. [3]Individuals whose fasting blood glucose is over 126mg/dL and HbA1c (NGSP) is over 6.5mg/dL. [4]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it). [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [6]Individuals who have digestive organ disease (disease of an appendix is removed). [7]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females). [8]Individuals whose BMI is over 30kg/m2. [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [10]Individuals with serious anemia. [11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies. [12]Individuals who cannot intake every loading food or test food. [13]Individuals who are or are possibly pregnant, or are lactating. [14]Individuals who are based on average alcohol per 1 day and exceeds 60g/day. [15]Individuals whose life style will change during the test period (ex. travel for a long time). [16Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for effectiveness (blood glucose, changes and Increase or decrease of insulin [screening, 30, 60, 90, and 120 minutes after rice intake], blood glucose AUC/iAUC, insulin AUC/iAUC [observation period I and II]). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Indexes for safety [1]Blood pressure, pulsation (screening, observation period I [before rice intake], observation period II [before rice intake]) [2]Weight, body fat percentage, BMI (screening, observation period I [before rice intake], observation period II [before rice intake]) [3]Doctor's questions (screening, observation period I [before rice intake, 120 minutes after rice intake], observation period II [before rice intake, 120 minutes after rice intake]) [4]Subject's diary (from one day before rice intake in observation period I to one day before rice intake in observation period II) *Other indexes [1]Hematologic test (screening) [2]Blood biochemical test (screening) [3]Urine analysis (screening) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed