Exploratory clinical study on the suppressive effect of the peptide on postprandial blood glucose level

Exploratory clinical study on the suppressive effect of the peptide on postprandial blood glucose level - Suppressive effect of the peptide on postprandial blood glucose level

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045225

Enrollment

Registered

2021-08-27

Start date

2021-08-27

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

A single intake of peptide food A single intake of placebo food

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects aged 20 years old or more and less than 65 years old. 2) Subjects whose fasting blood glucose levels are 125 mg/dL or less, and 2-h postprandial blood glucose levels are 199 mg/dL or less. 3) Subjects who have received a full explanation of the study, understand its contents, and have given their written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Subjects who are undergoing continuous medical treatment. 2) Subjects who regularly take Foods for Specified Health Uses, Foods with Function Claims, health foods, etc., which may affect the study, and who can not stop taking them during the study period. 3) Subjects who smoke 20 cigarettes or more per day. 4) Subjects with BMI of 30.0 kg/m2 or more. 5) Subjects who have difficulty in blood collection. 6) Subjects who are pregnant, planning to become pregnant, or lactating. 7) Subjects who have a past or current history of serious diseases of the heart, liver, kidney, digestive organs, etc. 8) Subjects who excessively take alcohol (60 g/day or more). 9) Subjects who have serious allergies to medicines and foods (especially eggs, wheat, and dairy products). 10) Subjects who are currently participating in another clinical trial of a drug or food, or participated in that trial within 4 weeks, or plan to participate in that trial after giving informed consent to participate in this trial. 11) Subjects who have donated over 200 mL of blood within 1 month and over 400 mL within 3 months before beginning this study. 12) Subjects who are judged as ineligible to participate in this study by the principal investigator or sub-investigator.

Design outcomes

Primary

Measure	Time frame
Area under the curve of blood glucose levels (0-120 min)	—

Secondary

Measure	Time frame
Postprandial blood glucose levels (each time point), Cmax of blood glucose level, Tmax of blood glucose level, insulin levels (0, 30 min), insulinogenic index	—

Countries

Japan

Contacts

Public ContactMasanori NUMA

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results