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A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet

Phase 2
Completed
Conditions
Healthy subjects whose HbA1c level is 5.5% to 6.5%
Registration Number
JPRN-UMIN000050020
Lead Sponsor
EZAKI GLICO Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

1)Persons who are suffering from illness and taking medication. 2)Persons who have past and current medical history of impaired glucose tolerance, psychiatric disorders, sleep disorders, hypertension, diabetes, hyperlipidemia, and other serious illnesses 3)Persons whose fasting blood sugar level is over 126 mg/dL or HbA1c (NGSP) level is over 6.5%. 4)Persons who have taken medication for the purpose of disease treatment within the last month (excluding headache, menstrual cramps, colds, etc.) 5)Persons have a past and current medical history of serious diseases about liver, kidney, heart, lung, blood, etc. 6)Persons have a past and current medical history about the digestive system disease (excluding history of appendectomy) 7)Persons whose BMI is over 30 kg/m2. 8)Persons who have donated more than 200 mL of blood within the last month and more than 400 mL within the last 3 months. 9)Persons have severe anemia 10)Persons who might have allergic symptoms on the test meal, and those who may have serious allergic symptoms to foods and pharmaceuticals. 11)Persons who might not have all test meal (including because of palatability) 12)Persons who are pregnant, breastfeeding or willing to breastfeed on the study period 13)Persons who drink more than 40 g/day in terms of average alcohol per day 14)Persons who may change their eating habits and lifestyle on the study period (ex, long-term travel) 15) Persons who have a habit of continuously taking foods with functional claims and health foods that claim to be related to sugar metabolism, and those who plan to take them during the test period with the last 3 months (Not including taking those for health maintenance) 17)Persons who are participating in the other tests with taking food and drugs

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the postprandial blood glucose level(2 hours after meals)
Secondary Outcome Measures
NameTimeMethod
Correlation between postprandial blood glucose level and blood pressure, body weight, BMI, waist circumference, blood results (total cholesterol, triglycerides, HDL-C, LDL-C, HbA1c)
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