None listed
Conditions
Interventions
Subjects take test food 1 (containing food ingredient) for 4 weeks. Before and after repeated intake, subjects take blood/feces sampling and answer the survey.
Subjects take test food 2 (containing fo
Sponsors
SUN THERA BIO Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male and female subjects whose ages are 40<= years old <65. (2) Subjects whose oxidative stress parameters (urinary 8-OHdG or OSI) are high. (3) Subjects who can visit the clinic on the scheduled inspection days. (4) Subjects who agree with the purpose and description of the study, and express informed consent via written documents. (5) Subjects who can wear the device during the study period.
Exclusion criteria
Exclusion criteria: (1) Subjects judged necessary to receive treatment by the principal investigator. (2) Subjects with any of the below: a) with disease on heart, liver, kidney or other organs complications. b) with respiratory disease c) with a previous history of disease on circulatory organs. d) contracting diabetes. e) with allergy to test food components. (3) With a previous history of severe disease such as inflammatory bowel disease or cancer or tuberculosis. (4) Constantly taking prescription/non-prescription or herbal drug medicine. (5) With allergic reaction to drug medicine and food. (6) With a previous history of feeling sick after blood sampling. (7) With difficulty in blood sampling from peripheral vein. (8) Whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2. (9) With systolic pressure under 90 mmHg. (10) Pregnant or lactating. (11) Subjects donated over 200 ml blood components or whole blood within the past 4 weeks prior to the current study. (12) Male who donated over 400 ml whole blood within the past 12 weeks prior to the current study. (13) Female who donated over 400ml whole blood within the past 16 weeks prior to the current study. (14) Male whose blood was collected over 1200 ml within the last 12 months. (15) Female whose blood was collected over 800 ml within the last 12 months. (16) Drinking alcohol a lot. (17) With irregular eating patterns. (18) Working irregular shifts or at midnight. (19) With excessive exercise habits defined as 7METs; habits: 5 times a week, over 30 minutes per time. (20) Smoking more than or equal to 21 cigarettes. (21) Planning irregular lifestyle and events during the study. (22) Participating in other clinical studies or finished study within the last 4 weeks. (23) Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxidative stress-related parameters(urinary 8-OHdG, d-ROMs test, BAP test, OSI) | — |
Countries
Japan
Contacts
Public ContactShinya Fukizawa
SUN THERA BIO Ltd. Research and Development
Outcome results
None listed