Effects of Supplementation in Healthy Russian Population

NCT02224092 | Completed

• 1 other identifier: Amway-2010-RU1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 consumption for eight weeks; (2) To test the safety and tolerability of the multivitamin multimineral with phytonutrient product vs. placebo following twice-daily consumption for eight weeks.

Conditions

Heart Health Markers; General Nutritional Status

Keywords

heart health; general well-being

Outcome Measures

Primary Outcomes (2)

• Change of heart risk factors by measuring homocysteine, C reactive protein (CRP), oxidized low-density lipoprotein (Ox-LDL) and lipid profile at baseline and Day 56

  Baseline, Day 56

• Change of nutrient status by measuring b-carotene, a- and r-tocopherol, vitamin C, folic acid, B6, B12, zinc, selenium, polyphenols at baseline, Day 28 and Day 56

  Baseline, Day 28 and Day 56

Secondary Outcomes (1)

• Change of potential heart health risk factors by measuring gamma-glutamyl transferase (GGT) and uric acid

  Baseline and Day 56

Other Outcomes (2)

• Change of anthropomorphic evaluation markers by measuring height, weight, body mass index (BMI, kg/m2), and waist-to-hip ratio at baseline and Day 56

  Baseline and Day 56

• Evaluation of general health status, lifestyle and dietary behavior

  Baseline

Study Arms (2)

Active

ACTIVE COMPARATOR

Active is a multivitamin multimineral with phytonutrient product.

Dietary Supplement: multivitamin multimineral with phytonutrient supplementation

Placebo

PLACEBO COMPARATOR

Placebo is a sugar pill.

Dietary Supplement: multivitamin multimineral with phytonutrient supplementation

Interventions

multivitamin multimineral with phytonutrient supplementation DIETARY_SUPPLEMENT

The multivitamin multimineral with phytonutrient product consists of four tablets per dose, two "Vitamin" tablets, a "Mineral" tablet, and a "Phytonutrient" tablet. The placebo for this trial will be formulated to match the shape and color of all multivitamin multimineral with phytonutrient product tablets, e.g., a Vitamin Placebo, a Mineral Placebo and a Phytonutrient Placebo.

Also known as: Active is Nutrilite Double X

Active; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Access Business Group: lead
• Russian Institute of Nutrition: collaborator

Study Sites (1)

Russian Institute of Nutrition

Moscow, Russia

Location

Study Officials

• Vasily A Isakov, M.D., Ph.D.

  Russian Institute of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: August 25, 2014
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2013
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

RU (1)