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Clinical trial for evaluation of effects on postprandial blood glucose levels of a test food

Randomized, single-blind, standard food-controlled crossover study of the effects of test food intake on postprandial blood glucose - Clinical trial for evaluation of effects on postprandial blood glucose levels of a test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043590
Enrollment
20
Registered
2021-04-06
Start date
2021-04-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults who tend to have high blood glucose levels

Interventions

Sponsors

Medical Corporation Chiseikai Tokyo Center Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects aged 20 or more and less than 65. 2) Subjects who meet any of the following criteria in the preliminary survey. i) Fasting blood glucose level is 100 mg/dL or more and less than 125 mg/dL. ii) 1-hour blood glucose level in 75-g oral glucose tolerance test (75 g OGTT) is 180 mg/dL or more. iii) 2-hour blood glucose level in the 75 g OGTT is 140 mg/dL or more and less than 200 mg/dL. iv) HbA1c value is 5.6 % or more and less than 6.5 %.

Exclusion criteria

Exclusion criteria: 1) Subjects who exhibit allergic symptoms due to intake of milk or soybean-derived ingredients. 2) Subjects who donated/collected blood components or 200 mL or more of blood in the past 1 month, or who donated/collected 400 mL or more of blood on the past 4 months. 3) Subjects who meet both of the following criteria in the preliminary survey. i) HbA1c value is 6.5 % or more. ii) Fasting blood glucose level is 126 mg/dL or more, or 75 g OGTT 2-hour blood glucose level is 200 mg/dL or more. 4) Subjects who have been diagnosed with diabetes. 5) Subjects taking medications that may affect blood glucose levels. 6) Subjects who plan to participate in other clinical trials during the trial period. 7) Subjects who are under medical treatment of diseases in liver, kidneys, heart, lungs, digestive system, blood, endocrine and metabolic systems, or who have serious medical history of those diseases. 8) Others who are judged by the investigator to be inappropriate as participants in this test.

Design outcomes

Primary

MeasureTime frame
Area under the curve of postprandial blood glucose

Countries

Japan

Contacts

Public ContactEri Kokubo

Morinaga Milk Industry Co., LTD. R&D Division Wellness&Nutrition Science Institute

e-karita@morinagamik.co.jp046-252-3057

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026