None listed
Conditions
Interventions
[1] Intake of test food/loading food (1 time/1 packet). [2] Observation. [3] Washout (over 6days) [4] Intake of placebo food/loading food (1 time/1 packet). [5] Observation.
[1] Intake of placebo
Sponsors
Riken Vitamin 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 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, 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 of serious hepatopathy, kidney damage, heart disease and hematological disease. 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 are sensitive to the test food. 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 within the past 3 months have a habit of continuously consuming foods with functional claims or health foods that claim to be related to glucose metabolism, or who plan to consume them during the test period. 12) Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). 13)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). 14)Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. 15)Individuals who engage in a night work. 16)Individuals who are or are possibly, or are lactating. 17)Females who menstruate on the day of the test and become anemic or feel unwell during the menstrual period. 18)Individuals who have difficulty in intaking the entire load food and test food (including preference). 19)Individuals who participated in other clinical studies in the past 3 months. 20)Individuals who are or whose family is engaged in functional foods or cosmetics. 21)Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level (GLU) due to loading food intake (before loading, 30, 60, 90, and 120 minutes after loading) (Observation period I and II) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes 1) Insulin (IRI) due to loading food intake (before loading, 30, 60, 90, and 120 minutes after loading) (1) 2) 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