Healthy adults
Conditions
Interventions
Test food to Control food: Beverage Intake: 125 ml/dose Loaded meal: Commercial aseptic white rice (200g) Transition from the test food to the control food with a 2-week pause
Control food to Test
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese men and women who are between 20 and 65 years of age at the time of consent acquisition. 2)Those whose glucose level is between 100 mg/dL and 125 mg/dL or whose HbA1c (NGSP) level is between 5.6% and 6.5% as a result of screening test. 3)Persons who have been fully informed of the purpose and content of the research,have the capacity to consent,have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research,and have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1)Those suffering from or undergoing treatment for serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases. 2)Persons with chronic diseases and regular users of medicines. 3)Persons with gastrointestinal diseases affecting digestion and absorption and a history of gastrointestinal surgery (excluding appendicitis) 4)Persons taking medicines that may affect blood glucose levels. 5)Those who cannot stop taking supplements or health foods (including foods for specified health uses and foods with functional claims) that may affect blood glucose levels, blood lipids, or body fat during the study period. 6)Persons with a history or current medical history of drug or alcohol dependence. 7)Those who are unable to abstain from alcohol for 2 days prior to each examination. 8)Persons who are judged by the principal investigator to be unsuitable as research subjects based on blood tests performed during the screening test. 9)Those who are diagnosed as anemic by screening tests and are not suitable for frequent blood sampling. 10)Persons who developed diarrhea within 1 week prior to the screening test date, or who are normally prone to diarrhea. 11)Persons who have donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 12)Those who have declared that they are allergic to the components of the research food (fruits) or to the load food (sesame). 13)Persons who are participating, or intend to participate, in studies (trials) involving the ingestion of other foods or the use of medicines, or the application of cosmetics and medicines. 14)Pregnant, intending to become pregnant during the study period, possibly pregnant, or breastfeeding. 15)Other persons deemed inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration curve (AUC) and change over time, Cmax, deltaCmax for glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the blood concentration curve (AUC) and change over time, Cmax, deltaCmax of insulin | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed