Influence on physical condition by "healthy meal" intake on males with high blood glucose
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000043836
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Not provided
1) Subjects who are unable to continuously intake "healthy meal" during intake period 2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination 3) Subjects who are judged as unsuitable for the study based on the medical history 4) Subjects with food allergies 5) Subjects who have difficulty in treatment by participating in the study 6) Subjects who are receiving treatment or use equipment that affects the examination 7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 8) Subjects who have participated in other clinical study prior to the current study 9) Subjects who routinely take health foods that may affect the results 10) Subjects who regularly consume large amount of alcohol 11) Subjects who smoke excessively (more than 21 cigarettes a day) 12) Subjects with extremely irregular diet 13) Subjects with irregular life rhythms 14) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study 15) Subjects who plan to donate blood during the study period 16) Subjects who judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c, fasting blood glucose at 4 week test
- Secondary Outcome Measures
Name Time Method Blood glucose / insulin level after 75 g OGTT, each change amount, area under the concentration time curve (blood glucose / insulin AUC), blood glucose peak value (blood glucose / insulin Cmax), insulin, HOMA-IR, adiponectin, insulin, HOMA-beta at 4 week test