Nothing (healthy subject)
Conditions
Interventions
C-003) 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, and 4 weeks.
Test food (product code
A-003) 5 times of effective dose size per day for 4 weeks, safety evaluations are performed at 0, 2, and 4 weeks.
Sponsors
New Drug Research Center, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. BMI>=22.0 and <30 kg/m2 2. BMI>=20 and <65 years-old 3. Individual provides informed consent by a document.
Exclusion criteria
Exclusion criteria: 1.Individual with liver, kidney and heart disease, or disorder of respiration, endocrine,metabolism, nervous system, consciousness, or diabetes, or other diseases. 2.Individual given surgery within 2 months before the final examination. 3.Medicine user for hyperglycaemia, lipidemia, or hypertension. 4.Individual intakes the food for specific use of health authorized the government and foods with function claims 5.Individual experienced unpleasant feeling by drawing blood in the past. 6.Individual donated 200 ml or more of blood within a month prior to the study. 7.Individual changed his/her weight 2 kg or more within 1month before the trial. 8.Night worker and shift worker. 9.Individual plans business trip for 10 consecutive days or more. 10.Individual can't intake test meal. 11.Individual had allergy against any constituents in the test meal. 12.Individual can not conform to control of alcohol(equivalent of 500 ml of beer per day). 13.Individual can not conform to record of "life daily"every day during the period of the test. 14.Individual can not conform to record of daily diet for 9 days(3 days x 3 times). 15.Individual cannot allow operator to consult his/her data of the past health check. 16.Individual have already participated other clinical trial and will participate. 17.Individual can not agree with preliminary explanation. 18.Pregnant women or breast-feeding women. 19.Individual who was judged ineligibles by clinician in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation(repeated ingestion for 4 weeks) Incidence of adverse effect | — |
Secondary
| Measure | Time frame |
|---|---|
| anthropometric parameters blood hematology blood biochemical test urine test | — |
Countries
Japan
Contacts
Public ContactSaori Konagai
New Drug Research Center, Inc. Clinical Research Dept.
Outcome results
None listed