None listed
Conditions
Interventions
Dietary Supplement : Next Gen DOUBLE X™ supplement and color-matched placebo. Each treatment entails taking two each of three different tablets, twice a day, for a total of twelve tablets a day, for u
Sponsors
Ewha Womans University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DNA damage ;Source of oxidative stress in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid damage in plasma | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeyun Jeong
Ewha Womans University
Outcome results
None listed