A study on the effect of single intake of the test food on blood sugar-related biological markers -a placebo-controlled, double-blind, four-period crossover trial-

A study on the effect of single intake of the test food on blood sugar-related biological markers -a placebo-controlled, double-blind, four-period crossover trial- - A study on the effect of single intake of the test food on blood sugar-related biological markers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045502

Enrollment

Registered

2022-10-08

Start date

2021-10-30

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 adults

Interventions

Take the placebo food (350 mL, room temperature) within 10 min in a sitting position with resting. Take the test food A (350 mL, room temperature) within 10 min in a sitting position with resting. Tak

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Aged between over than 20 years old, and less than 60 years old. 2. Japanese males. 3. Body weight between 50 to 70 kg. (Also, BMI less than 25.0 kg/m^2) 4. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals who currently have been taking any medication drugs or Chinese herbal medicines for medical treatments. (Single dose to be taken only once is approved.) 2. Individuals who have severe diseases or a history of severe diseases, such as cardiac-, hepatic-, kidney-, and digestive- diseases. 3. Individuals who are managed by medical doctors for diet therapy and exercise therapy. 4. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims which affect blood sugar levels. (However, individuals who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial.) 5. Individuals who drink more than 60 g alcohol/day. 6. Individuals who live irregular life rhythms, such as work in shift, night shift, and marked irregular eating habits. 7. Individuals who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials between 4 weeks after this trial. 8. Individuals who can't stop drinking one day before the experimental day. 9. Individuals who have drug allergies and food allergies. 10. Individuals who are unsuitable for this trial, that judged by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Fibroblast growth factor-21 (FGF-21)	—

Secondary

Measure	Time frame
Blood glucose level	—

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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