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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035710
Enrollment
50
Registered
2019-02-01
Start date
2019-02-02
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

None listed

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females aged 20 to 64 years-old. (2)Subjects whose fasting blood glucose level is from 100 mg/dL to 125 mg/dL or two-hour blood glucose level after 75 g glucose loading is from 140 mg/dL to 199 mg/dL, and causal blood glucose level is under 200 mg/dL and who are judged normal-high or borderline type as the state of glycemia by the principal investigator. (3) Subjects who do not habitually consume a large amounts of alcohol. (4)Subjects who can make self-judgment and are voluntarily giving written informed consent.

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. (2) Subjects who use medications affecting blood glucose level. (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose level during test periods. (4) Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods. (5) Subjects who are diagnosed as diabetes by the screening tests I or II. (6) Subjects who contract, are under treatment for or have a history of serious diseases (e.g., kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (7) Subjects who have a chronic disease and regularly use medications. (8) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (9) Subjects who are judged unsuitable for the current study by the screening tests. (10) Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling. (11) Subjects who have had diarrhea within the last one week prior to the screening tests. (12) Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study. (13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (14) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are planning to become pregnant after informed consent, pregnant or lactating. (16) Subjects who are judged unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Blood glucose AUC

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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