Effects of a dairy ingredient on subjective symptoms in healthy subjects: a randomized, double-blind, placebo-controlled trial.
- Conditions
- one (Healthy subjects)
- Registration Number
- JPRN-UMIN000048087
- Lead Sponsor
- Kyushu University of Health and Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Not provided
1)Subjects who regularly consume foods containing a dairy ingredient to be evaluated. 2)Subject who plans or wish to get vaccinated or donate blood during the test period. 3)Extremely heavy drinkers (more than 60g/day of alcohol). 4)Subjects who can not sleep at night due to irregular work or other reasons. 5)Subjects who take medicines or functional foods during the pre-test period, which might affect their subjective symptoms and/or immune function. 6)Subjects who can not stop taking medicines or functional foods during the test period, which might affect their subjective symptoms and/or immune function. 7)Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these. 8)Subjects having chronic disorders. 9)Subjects who are positive in the pathogen test. 10)Subjects who need the application of medicine containing steroids. 11)Subjects having a milk allergy. 12)Subjects who have medical history of drug allergy or severe food ones. 13)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study. 14)Subjects who donated 400 mL of their blood within 12 weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the pre-test period. 15)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective symptoms
- Secondary Outcome Measures
Name Time Method Immune indices