impaired glucose tolerance
Conditions
Interventions
fermented dairy product containing lactic acid bacteria
placebo (non-fermented dairy product)
Sponsors
Nishi-Shinjyuku Kisaragi Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) An age 20 years or older and up to 64 years 2) A BMI of 25 or more 3) A 1-hour plasma glucose level during OGTT of 180 mg/dL or more 4) A 2-hour plasma glucose level during OGTT of about 140 to 199 mg/dL
Exclusion criteria
Exclusion criteria: 1) Subjects who consume lactic acid bacteria beverage, lactic acid bacteria -rich food or lactic acid bacteria preparation more than 3 times a week 2) Subjects routinely taking medicine or health food which may influence glucose metabolism 3) Subjects who are under medication which may influence the outcome of the study 4) Subjects with a history of serious disease, e.g., liver disease, kidney disease, hypertension, or ischemic heart disease 5) Subjects with allergies to dairy products used in the study 6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination 7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 9) Subjects who are judged as unsuitable for the study by physician for other reason
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| fasting plasma glucose, insulinogenic index (II),homeostasis model assessment of beta-cell function (HOMA-beta), Matsuda index, homeostasis model assessment-insulin resistance (HOMA-IR), serum insulin level during OGTT, glycoalbumin, HbA1c, serum cholesterol level (non-HDL cholesterol, LDL cholesterol, total cholesterol, and HDL cholesterol) The effects on the secondary outcomes are evaluated not only in all subjects but also in the subgroup with impaired early insulin responses (insulinogenic index <0.4). | — |
Primary
| Measure | Time frame |
|---|---|
| Glucose tolerance (maximum plasma glucose level, area under the curve of plasma glucose, glucose spike (the difference between maximum plasma glucose and fasting plasma glucose), and plasma levels of glucose (30, 60, 90 and 120 min) during 75-g oral glucose tolerance test (OGTT)) The effects on the primary outcomes are evaluated not only in all subjects but also in the subgroup with impaired early insulin responses (insulinogenic index <0.4). | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed