Status:
COMPLETED
Effects of Supplementation in Healthy Russian Population
Lead Sponsor:
Access Business Group
Collaborating Sponsors:
Russian Institute of Nutrition
Conditions:
Heart Health Markers
General Nutritional Status
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The objectives of this exploratory study are to (1) evaluate the effect of the multivitamin multimineral with phytonutrient product vs. placebo on heart health risk factors following twice-daily consu...
Detailed Description
More and more evidence shows the benefit of fruit and vegetable intake on the maintenance of good health throughout the lift span. Unfortunately, many people in developed and developing societies do n...
Eligibility Criteria
Inclusion
- Generally healthy men and women aged from 40 to 70 years of age preferable smokers and who regularly consumes alcohol, and consuming fewer than 12 items found on the Recommended Foods Checklist (see below) per week.
- Individual should be judged to be in good general health on the basis of an interview and abbreviated physical exam.
- Individual understands the procedures and agrees to participate in the study.
- Individual is able and willing to provide written informed consent and confidentiality agreement.
Exclusion
- Use of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks.
- Presence of cardiovascular disease, hypercholesterolemia, cancer, diabetes mellitus, or any other chronic health condition identified from the findings of the interview.
- Currently treated for uncontrolled hypertension or blood pressure greater \> 140 mm Hg systolic or \> 90 mm Hg diastolic during seated, resting measurement on two consecutive occasions during visit 1.
- Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within four weeks of Day 1.
- Participation in another clinical trial within 30 days of enrollment into the study.
- History or current abuse of drugs or alcohol, or intake \> 4 alcoholic beverages per day.
- Known hypersensitivity to study product or any ingredient in study product.
- 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.
- Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control.
- Any condition that the Principal Investigator believes may put the subject at undue risk.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02224092
Start Date
October 1 2010
End Date
September 1 2013
Last Update
August 25 2014
Active Locations (1)
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1
Russian Institute of Nutrition
Moscow, Russia