N/A (healthy adults)
Conditions
Interventions
Oral intake of the test food (118g in a day
12 weeks).
Oral intake of the placebo food (118g in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and females aged 20-65 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals whose fasting blood glucose is over 100mg/dL and less than 110mg/dL or over 110mg/dL and less than 126mg/dL. [4]Individuals whose BMI is over 18.5 and under 30. [5]Individuals whose written informed consent has been obtained. [6]Individuals who can come to the designated venue for this study and be inspected. [7]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 psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [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 whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals who experienced unpleasant feeling during blood drawing. [10]Individuals who are sensitive to a test product or other foods, and medical products. [11]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). [12]Individuals who have a habit to intake a product similar with a test food. [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 are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in functional foods or cosmetics. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for efficacy and safety (lipid metabolism evaluation [fasting blood sugar level, HbA1c, glycoalbumin, insulin, HOMA-R(1)](2), antioxidation performance evaluation [d-ROMs test: oxidative stress, BAP test: antioxidation performance, BAP/d-ROMs ratio(1)](3), and safety evaluation [number of cases and expression rate of side effects [expression rate: number of cases/number of cases analyzed](4)). (1)Calculated value. (2)Screening, Week 0, Week 4, Week 8, Week 12. (3)Week 0, Week 8, Week 12. (4)After intake period. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 4, Week 8, Week 12) [2]Blood test (pentosidine, carboxymethyl lysine) [3]Blood pressure, pulsation (SCR, Week 0, Week 4, Week 8, Week 12) [4]Weight, body fat percentage, BMI (SCR, Week 0, Week 4, Week 8, Week 12) [5]Hematologic test (SCR, Week 0, Week 4, Week 8, Week 12) [6]Blood biochemical test (SCR, Week 0, Week 4, Week 8, Week 12) [7]Urine analysis (SCR, Week 0, Week 4, Week 8, Week 12) [8]Anti-Aging QOL Common Questionnaire (SCR, Week 4, Week 8, Week 12) [9]Doctor's questions (SCR, Week 0, Week 4, Week 8, Week 12) *Other index [1]Subject's diary (each day during the test period) [2]Dietary survey (3 days prior to each inspection date) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed