Healthy
Conditions
Keywords
supplement, omega-3 fatty acid, Homocysteine, LDL cholesterol
Brief summary
The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.
Detailed description
Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.
Interventions
DRUGCooper Complete One-A-Day Vitamin Supplement
Sponsors
Cooper Clinic
The Cooper Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks
Exclusion criteria
* BMI \<18.5 or \>34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| homocycsteine | — |
| LDL cholesterol oxidation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting plasma glucose | — |
| C-reactive protein | — |
Countries
United States
Outcome results
None listed