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Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial-

Examination of the efficacy of single dose high gamma-PGA natto on the suppression of postprandial glucose elevation. -A randomized crossover confirmatory trial- - The single-dose confirmatory trial of the high gamma-PGA natto

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037449
Enrollment
36
Registered
2019-08-02
Start date
2019-08-02
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 subjects

Interventions

Low gamma-PGA natto High gamma-PGA natto

Sponsors

Clinical and translatnal methodology, Fuculty of Medicine, University of Tsukuba
Lead Sponsor
1. Takanofoods Co., Ltd. 2. Industrial technology innovation center of Ibaraki prefecture. 3. National agriculture and food research organization, food research institute.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [At the primary registration] 1. Men and postmenopausal women aged 20-70 years old. 2. BMI not less than 18.5 kg/m2, under 25.0 kg/m2. 3. FPG less than 126 mg/dL and HbA1c less than 6.5%. 4. Subjects who can maintain an everyday lifestyle during study period constantly 5. Capable of giving informed consent. [At the secondary registration] Subjects who meet the following conditions after the meal loading test with 150g of white rice, that performed after primary registration. 1. The levels of casual plasma glucose less than 200 mg/dL. 2. Priority is given to those with a plasma glucose levels more than 140 mg/dL at post-30 min or at any point of time.

Exclusion criteria

Exclusion criteria: [At the primary registration] 1. Subjects who are treated for diabetes. 2. Subjects who are taking medications for dislipidemia hypertention, and anemia. 3. Subjects who are taking warfarin. 4. Subjects who are habitually taking medication and/or supplement (including "food for specified health use", and "foods with function claims") that affect glucose metabolism. 5.Subjects who are diagnosed for anemia or have treatment history for anemia. 6. Subjects who are difficult to collect blood in health checkup and so on oftenly. 7. Subjects who are enrollment in another interventional study. 8. Subjects who have suspected food allergy to test meal 9. Subjects who were recognized unsuitable for this study by the Investigator. [At the secondary registration] 1. Subjects who are confirmed to be difficult to collect blood during continuous blood collection using indwelling needle 2. Subjects who were recognized unsuitable for this study by the Investigator.

Design outcomes

Primary

MeasureTime frame
Incremental area under the curve of plasma glucose (0-30 min)

Secondary

MeasureTime frame
1.Incremental area under the curve of plasma glucose (0-15, 0-45, 0-60, 0-90, 0-120 min) 2.The level and change from baselaine of plasma glucose (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 3.The level and change from baseline of plasma insulin (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 4.Organoleptic evaluation (eating quality of test meal)

Countries

Japan

Contacts

Public ContactKoichi Hashimoto

University of Tsukuba, Faculty of Medicene Clinical and translatnal methodology

koichi.hashimoto@md.tsukuba.ac.jp029-853-3064

Outcome results

None listed

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