JPRN-UMIN000033364Completed未知
Verification of improvement effect for insulin sensitivity - Verification of improvement effect for insulin sensitivity
CPCC Company Limited0 sites120 target enrollmentStarted: March 31, 2020Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
A significant increase in total bifidobacterial count was observed in the test-food (TF) group compared to the control. But, the control subjects who had a significant increase in daily steps showed improvements in glucose metabolism-related markers. In the TF group, a significant positive correlation between the increased number of total bifidobacterial count and the change in Matsuda-index, suggested an insulin-sensitivity recovery. This is consistent with the prior results (UMIN000023480).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 60years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) Subjects who didn't undergo abdominal surgical operation within 6 month before test start. 2) Subjects who are being treated medication at present. 3) Subjects who have allergy to test food. 4) Smokers 5) Subjects their living together has plane to participate to same clinical test. 6) Subjects who plan big change of lifestyle during test period. 7) Subjects with tendency of chronic diarrhea. 8) Subjects who have inappropriate medical history such as significant functional impairment in liver, kidney and/or heart-blood system. 9) Subjects who suspected chronic or serious infectious disease. 10) Females who are pregnant, lactating or possibility of pregnancy. 11) Subjects who have participated the other clinical test within 3 month before test start. 12) Subjects who can't refrain from consumption of lactic bacteria, bifidobacterium, oligosaccharide and/or dietary fiber rich foods during test period, of fermented foods such as the natto, pickles and/or cheese. 13) Subjects who regularly consume the supplement containing similar ingredient of Xanthophyll, a vegetable juice and/or a tomato juice more than 5 days a week. Subjects who can't refrain from consumption of the supplement and/or the juice mentioned above, of the wenzhou mandarin orange and/or that juice during test period. 14) Subjects who donated over 200mL blood and/or blood components within a month. 15) Males who donated over 400mL blood within the last 3 months. 16) Females who donated over 400mL blood within the last 4 months. 17) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. 18) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. 19) Others they have been determined ineligible by principal investigator or sub-investigator.
Investigators
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