None listed
Conditions
Interventions
[1]Oral ingestion of a test food (1 time). [2]Rice load. [3]Observation. [4]Washout (over 6 days). [5]Oral ingestion of a placebo food (1 time). [6]Rice load. [7]Observation.
[1]Oral ingestion
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Males and females aged 20-59 years. 2)Individuals who are healthy and have no chronic physical disease. 3)Individuals whose written informed consent has been obtained. 4)Individuals who can come to the designated venue for this study and be inspected. 5)Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1)Individuals using medical products. 2)Individuals who are patient or have a history of glucose intolerance, Gastrointestinal disorders, psychiatric disease, sleep disorder, high blood pressure, diabetes, and hyperlipidemia. 3)Individuals whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%. 4)Individuals who have a history or current history of serious illness involving the liver, kidneys, heart, lungs, stomach, blood, etc. 5)Individuals who are a patient or have a history of or endocrine disease. 6)Individuals who used a drug to treat a disease in the past 1 month. 7)Individuals whose BMI is over 30 kg/m2. 8)Individuals who with drug or food allergies. 9)Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 10)Individuals who experienced unpleasant feeling during blood drawing. 11)Individuals who currently or have in the past 3 months had a habit of continuously consuming foods that may affect the study, or functional foods or health foods that claim to suppress glucose metabolism or absorption, or those who plan to consume such foods during the study period. 12)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 13)Individuals with possible changes of life style during the test period. 14)Individuals who engage in a night work. 15)Individuals who are or are possibly, or are lactating. 16)Females who menstruate on the day of the test and become anemic or feel unwell during the menstrual period. 17)Individuals who have difficulty in intaking the entire load food and test food. 18)Individuals who participated in other clinical studies in the past 3 months. 19)Individuals who are or whose family is engaged in functional foods or cosmetics. 20)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level (GLU) after eating rice (Observation period I and II : before eating rice, 30, 60, 90, 120, and 180 minutes after eating rice) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Insulin by rice loading ( before loading, 30, 60, 90, 120, and 180 minutes after loading)(1) [2] Special blood test by rice loading(1) [3] Visual Analogue Scale by rice loading(1) [4] HOMA-IR, HOMA-beta(1) *Safety [1] Blood pressure, pulsation (1) [2] Weight, body fat percentage, BMI (1) [3] Doctor's questions (1) [4] Subject's diary (2) (1): Observation period I and II (2): From Observation Period I to the day before the Observation Period II | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed