Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study

Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
INTERVENTION: SekirenB2 Placebo CONDITION: Healthy individual PRIMARY OUTCOME: We decide the value in front of test food ingestion start is standard and it is 0 hour.; We check the amount of change of the blood glucose level after ingesting test food and measure the level in 0.5, 1, 1.5, 2, 2.5, 3, 4 hours later. SECONDARY OUTCOME: We decide the value in front of test food ingestion start is standard and it is 0 hour.; We check the amount of change of theblood test item and the urinalysis item 4 hours later. INCLUSION CRITERIA: 1)A person who is Japanese and between 20 and 65 years old at the time of informed consent.(Sex is not asked) 2)A person who has blood pressure and body temperature of the following value at this clinical trial and the screening. Blood pressure: Systolic Less than 140mmHg Diastolic Less than 90mmHg Body temperature: 35.5‐37.0 degrees 3)A person whose HbA1c is applied to following either value. a)HbA1c:6.4% or less b)HbA1c:6.5% or more and less than 7.0% 4)A person must be received to explanation about the test food,objective of clinical test and side effects by clinical research investigator or sub investigator. And the person who understood explanation well,agreed with written informed consent and desired participation in the clinical trial. 5)A person who can quit smoking on the day of clinical trial. 6)A person who can obey management manner in implementation medical institutions. 7)A person who can d
Epistemonikos ID: d1126b7d6c6f3c3b55d8f7c575f00ad3e3f8a172
First added on: Aug 23, 2024