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Evaluation of the postprandial blood glucose

Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: A randomized, placebo-controlled, double-blind, crossover trial - Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043477
Enrollment
40
Registered
2021-03-01
Start date
2021-02-23
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 Japanese subjects

Interventions

Period I: Food containing lactic acid bacteria Period II: Placebo Carbohydrate load: Trelan-G 75 g Administration: &lt
Screening&gt
After taking blood samples before intake, take the carbohydrate load within 10 minutes. &lt
After taking blood samples before intake, eat test food with a glass of water (approximately 200 mL). 30 minutes after eating test food, take the carbohydrate load within 10 minutes. *The intervent

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Female 3. Subjects 40 or over to under 80 years old 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose postprandial blood glucose level (Cmax) is 140 mg/dL to 199 mg/dL in the screening

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements. 6. Subjects who are allergic to medicines and/or the test food related products. 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period 9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Design outcomes

Primary

MeasureTime frame
The incremental area under the curve (IAUC) of the blood glucose levels

Secondary

MeasureTime frame
1. The levels of maximum (Cmax) blood glucose 2. The blood glucose level before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food

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: Jul 3, 2026