Skip to content

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized double-blind placebo-controlled trial - A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043321
Enrollment
30
Registered
2021-02-15
Start date
2021-02-15
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

Healthy adult

Interventions

1)Test food + rice 200 g, single ingestion 2)Wash out for 1 week 3)Placebo food + rice 200 g, single ingestion 1)Placebo food + rice 200 g, single ingestion 2)Wash out for 1 week 3)Test food + ric

Sponsors

Pharma Foods International Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Japanese male and female aged 20-64 years old at the time of the informed consent 2) Subjects whose fasting blood glucose level is less than 126 mg/dL or two-hour blood glucose level after 75 g glucose loading is less than 200 mg/dL at the screening test. 3) Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.

Exclusion criteria

Exclusion criteria: 1)Subject who is considered as a diabetes by a doctor. 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness(depression) or sleep disturbance. 7)Subject who is on a night-shift or is a shift worker. 8)Subject whose lifestyle is extremely irregular. 9)Subject who has an unbalanced diet. 10)Subject who is current disease or history of brain disorder, cancer, immunity disorder, diabetes, liver disease(hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 11)Subject who is use health foods, supplements, and medicines that may affect diabetes. 12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13)Subject who has blood drawn 200 mL within the past 1 months or 400 mL within the past 3 months from the day of the consent acquisition. 14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15)Subject who can't keep the daily records. 16)Subject who is judged as an inappropriate candidate according to the screening data. 17)Subject who is considered as an inappropriate candidate by the doctor in charge.

Design outcomes

Primary

MeasureTime frame
- Blood glucose *Measure at before ingestion and 15, 30, 45, 60, 90, and 120 minutes after ingestion. - Area Under the Curve

Countries

Japan

Contacts

Public ContactDaisuke Ochitani

HUMA R&D CORP Clinical Development Division

ochitani@huma-rd.co.jp03-3431-1260

Outcome results

None listed

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