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Randomized placebo double-blind study on improvement of blood glucose level by test food for type 2 diabetes preliminary group

Randomized placebo double-blind study on improvement of blood glucose level by test food for type 2 diabetes preliminary group - Diabetes related factor improvement study by test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035487
Enrollment
40
Registered
2019-02-25
Start date
2019-02-22
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

Diabetes preliminary group

Interventions

Duration: 12 weeks. Test materials: Test food Does: 4.5g per day. Duration: 12 weeks. Test materials: Placebo food Does: 4.5g per day.

Sponsors

Nitta Gelatin Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy subjects from 35 years old over. 2. Subjects who can visit the examination place on a fixed schedule. 3. Subjects who can cooperate with weight measurement, a questionnaire and blood sampling test. 4. Subjects who can ingest test food or placebo food dissolved with water etc., once a day during the examination. 5. Subjects who can fill up the examination record everyday. 6.HbA1c is >=5.0%, <6.4% 7.Fasting blood sugar level is 80-110 mg/dl

Exclusion criteria

Exclusion criteria: 1. Subjects who have food allergy. Especially subjects who are sensitive to gelatin. 2. Subjects who have been medical history of physical disorder when they took supplements. 3. Subjects who are diabetes. 4. Subjects who take medicine and/or food for specified health use. 5. Subjects who took supplements and/or medicine for improvement of diabetes 1 month.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose level, HbA1c, QOL score, AGEs measurement at 0,4,8,12 weeks, Sugar tolerance test at 0, 12 weeks

Countries

Japan

Contacts

Public ContactSeiko Koizumi

Nitta Gelatin Inc. R&D center

se-koizumi@nitta-gelatin.co.jp072-948-8252

Outcome results

None listed

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