Effects of consumption of the test food on postprandial blood glucose level in healthy Japanese

Effects of consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on postprandial blood glucose level in healthy Japanese

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000062001

Enrollment

106

Registered

2026-06-22

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

Duration: 8 weeks Test product: Food Duration: 8 weeks Test product: Placebo food

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose Cmax of the blood glucose level after consumption of the carbohydrate load is 140-199 mg/dL at screening (Scr)

Exclusion criteria

Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are a smoker 5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 6. Individuals who are taking or using medications (including herbal medicines) or supplements 7. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day 8. Individuals who take dairy products such as milk and cheese at least four times a week 9. Individuals who are allergic to medications or foods related to the test food (particularly gelatin) 10. Individuals who are pregnant, lactating, or planning pregnancy during this study 11. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
1. The incremental area under the curve (IAUC) of blood glucose level at 8 weeks after consumption (8w)	—

Secondary

Measure	Time frame
1. The maximum blood concentration (Cmax) of blood glucose level at 8w 2. The blood glucose level at fasting (before consumption of the load), 30, 60, 90, and 120 minutes after consumption of the load at 8w 3. The difference from before carbohydrate load to Cmax (delta Cmax) of blood glucose level at 8w 4. The IAUC of insulin at 8w 5. Cmax of insulin at 8w 6.Delta Cmax of insulin at 8w 7. Matsuda Index at 8w 8. The insulin at fasting (before consumption of the load), 30, 60, 90, and 120 minutes after consumption of the load at 8w 9. Grip strength (dominant hand, non-dominant hand) at 8w 10. Individuals who experienced adverse events	—

Measure

Time frame

1. The maximum blood concentration (Cmax) of blood glucose level at 8w 2. The blood glucose level at fasting (before consumption of the load), 30, 60, 90, and 120 minutes after consumption of the load at 8w 3. The difference from before carbohydrate load to Cmax (delta Cmax) of blood glucose level at 8w 4. The IAUC of insulin at 8w 5. Cmax of insulin at 8w 6.Delta Cmax of insulin at 8w 7. Matsuda Index at 8w 8. The insulin at fasting (before consumption of the load), 30, 60, 90, and 120 minutes after consumption of the load at 8w 9. Grip strength (dominant hand, non-dominant hand) at 8w 10. Individuals who experienced adverse events

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026