A human study for evaluating the effects of multivitamin-multimineral supplement containing phytonutrients on antioxidant capacity and DNA stability
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0002055
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
Men and women aged 25 to 69 years, with no more than fifty percent of all subjects younger than 40 years of age.
-Recommended Foods Score of 36 or less.
-Smokers and non-smokers will both be allowed into the study. The ratio of smokers to non-smokers will be matched between the placebo and the intervention groups as equal as possible.
-Use of supplements, vitamins, or herb remedy within 8 weeks of the Screening visit.
-Body fat percentage (%) less than 20
-Presence of ongoing medical illness or medical history within 2 years before screening.
-Hypertension, diabetes, atherosclerosis, chronic inflammatory disease (rheumatoid arthritis, etc.), heart disease, kidney disease, liver disease, thyroid disease, malignant tumor, psychiatric disorder, etc.
-Patients who had other illness and the principal investigator judged as inappropriate candidates for the study
-Consistent medication within 4 weeks before screening: lipid-lowering agents, anti-inflammatory agents, antihypertensive drugs, blood glucose-lowering drugs, and antibiotics affecting the inflammatory response, antioxidant capacity, and lipid metabolism.
-Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within 4 weeks of the Screening visit. Preventive use of low-dose aspirin (e.g. 100-mg a day) is allowed.
-A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening, or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study.
-Weight loss of more than 4 kg in the 4 weeks before screening or participation in weight management program.
-History or current abuse of drugs or alcohol, or intake = 420 g pure alcohol/week. (e.g. more than 7 bottles of soju/week).
-Unwilling to maintain present exercise and dietary habits and lifestyles for the duration of the study.
(e.g. excessive exercise =7 hours/week, excessive smoking =10 cigarettes/day)
-Known hypersensitivity to study product or any ingredient in study product.
-Participation in another clinical trial within 4 weeks of enrollment into the study.
-Blood donation within past 4 weeks.
-Pregnant or lactating women
-Any condition that the Principal Investigator believes may put the subject at undue risk.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method