Randomized controlled trial of effects of long-term consumption of milk and dairy products in addition to dietary guidance on metabolic syndrome
Phase 2
- Conditions
- Metabolic Syndrome
- Registration Number
- JPRN-UMIN000006353
- Lead Sponsor
- Japan Dairy Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1.Smokers 2.Person who suffers health problem from consumption of dairy products, i.e. milk allergy 3.Person whose clinical laboratory test results are significantly out of standard value, and an investigator determined that he is required to take treatment. 4.Person who participated another clinical investigation or trial within 3 months from the start date of this study. 5.Person who has critical disease history such as cardiac disease, cerebrovascular disease, kidney disease and/or diabetic disease. 6.With other factors, an investigator determines that a person is unfit to participate the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight, Waist, Body Fat Percentage, Fasting Blood Sugar, HbA1c, Total Cholesterol, LDL Cholesterol, HDL cholesterol, Fasting Triglyceride, SBP, and DBP, evaluated at the time of registration, 3rd month and 6th month
- Secondary Outcome Measures
Name Time Method Food frequency questionnaire and questionnaire on exercise and sleeping habit, evaluated at the time of registration, 3rd month and 6th month