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A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-

A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- - A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038956
Enrollment
20
Registered
2020-01-05
Start date
2020-01-06
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

No (include borderline diabetes)

Interventions

Powder containing plant extract, 1 sachet per serving Powder not containing plant extract, 1 sachet per serving

Sponsors

TOYO SHINYAKU Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20 to 64 year-old. (2) Subjects who have enough information about its objective and details, can make self-judgment and voluntarily give written informed consent before they agree to participate. (3) Subjects who can obey the directions of the investigators.

Exclusion criteria

Exclusion criteria: (1) Subjects whose fasting blood glucose level is 126 mg/dL and over or two-hour blood glucose level after 75 g glucose loading is 200 mg/dL and over and/or who have been diagnosed with diabetes. (2) Subjects whose fasting serum triglyceride level is 45 mg/dL or less and 150 mg/dL or over, or casual serum triglyceride level is 650 mg/dL and over. (3) Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, digestive system disease, heart disease, respiratory disease, peripheral vascular disorder, etc.). (4) Subjects who use oral medication affecting blood glucose or lipid metabolism. (5) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Functional Claims) affecting blood glucose or lipid metabolism. (6) Subjects with abnormal parameters in liver and/or kidney function. (7) Subjects who have a history of digestive disease surgery. (8) Subjects with a disease that may have an influence on this study currently under treatment. (9) Subjects who have declared an allergic reaction to test foods, or loading foods. (10) Subjects with anemia or who have difficulty with self blood collection. (11) Subjects who play high intensity sports and/or are on a diet. (12) Subjects with irregular life patterns. (13) Subjects who use medicines (including OTC and/or prescribed medications) continuously. (14) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement. (15) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (16) Subjects who are planning to participate in other clinical studies. (17) Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Blood glucose AUC and Serum triglyceride AUC

Countries

Japan

Contacts

Public ContactNobutaka Kusaba

TOYO SHINYAKU Co., Ltd. Clinical and analytical research center

gakujutsu@toyoshinyaku.co.jp0942-81-3555

Outcome results

None listed

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