Heart Health MarkersNCT02224092
Effects of Supplementation in Healthy Russian Population
A study testing multivitamin multimineral with phytonutrient supplementation in people with Heart Health Markers and General Nutritional Status, run by Access Business Group at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Health Markers, General Nutritional Status
- What is being tested?
- multivitamin multimineral with phytonutrient supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multivitamin, Multimineral and Phytonutrient Supplementation on Selected Nutrients Blood Level and Heart Health Risk Factors in Russian Population
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.
Read the 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 not eat a diet with the variety and quantity of fruits and vegetables. Because of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden on the health care system. Therefore, promoting healthy lifestyle and dietary behavior becomes a critical approach in preventing chronic disease development. According to results from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the World Health Organization's recommended 400 grams per day. This lower than recommended intake would correlate to a lower intake of phytonutrients and antioxidants and may be associated with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In this study, we are particularly interested in understanding whether a multivitamin multimineral with phytonutrient product can improve nutritional status and reduce heart health risk factors in Russian population with low fruit and vegetable intake. This study is conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients department.
- Conditions
- Heart Health Markers, General Nutritional Status
- Being tested
- multivitamin multimineral with phytonutrient supplementation
- Keywords
- heart health, general well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multivitamin multimineral with phytonutrient supplementationDietary supplement
Also called Active is Nutrilite Double X
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Active is a multivitamin multimineral with phytonutrient product. Receives: Dietary Supplement: multivitamin multimineral with phytonutrient supplementation |
| Placebo | Placebo comparator | Placebo is a sugar pill. Receives: Dietary Supplement: multivitamin multimineral with phytonutrient supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Health MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Russian Institute of Nutrition
- Responsible party
- Sponsor
- Investigators
- Vasily A Isakov, M.D., Ph.D., Principal investigator, Russian Institute of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224092
- Sponsor's protocol ID
- Amway-2010-RU1
- Status last verified
- Aug 2014
- First submitted
- 19 Dec 2013
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multivitamin, Multimineral and Phytonutrient Supplementation on Selected Nutrients Blood Level and Heart Health Risk Factors in Russian Population
- ClinicalTrials.gov ID
- NCT02224092
- Acronym / sponsor ID
- Amway-2010-RU1
- Conditions
- Heart Health Markers, General Nutritional Status
- Keywords
- heart health, general well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Collaborators
- Russian Institute of Nutrition
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 not eat a diet with the variety and quantity of fruits and vegetables. Because of this, prevalence of chronic disease increases rapidly in worldwide as well as the burden on the health care system. Therefore, promoting healthy lifestyle and dietary behavior becomes a critical approach in preventing chronic disease development. According to results from the Moscow Behavioural Risk Factor Survey performed from 2000-2001 found that mean fruit and vegetable intake in men and women in Moscow was 190 grams per day, much lower than the World Health Organization's recommended 400 grams per day. This lower than recommended intake would correlate to a lower intake of phytonutrients and antioxidants and may be associated with higher risks for chronic diseases such as cardiovascular disease (CVD) and cancer. In this study, we are particularly interested in understanding whether a multivitamin multimineral with phytonutrient product can improve nutritional status and reduce heart health risk factors in Russian population with low fruit and vegetable intake. This study is conducted in Russia Institute of Nutrition (ION) clinic, which has 200 beds and outpatients department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: multivitamin multimineral with phytonutrient supplementationActive is a multivitamin multimineral with phytonutrient product. |
| Placebo | Placebo comparator | Dietary Supplement: multivitamin multimineral with phytonutrient supplementationPlacebo is a sugar pill. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multivitamin multimineral with phytonutrient supplementationAlso: Active is Nutrilite Double XThe 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. | Dietary supplement | Active, Placebo |
Primary outcome
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
Time frame: 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
Time frame: Baseline, Day 28 and Day 56
1 secondary outcome
Change of potential heart health risk factors by measuring gamma-glutamyl transferase (GGT) and uric acid
Time frame: Baseline and Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
Related trials for Heart Health Markers
Not yet recruitingPhase 4
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Recruiting
Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga
Insomnia, Health Adult Subjects
Recruiting
Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health
Cardiovascular Diseases, Cognition
Recruiting
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Myocardial Infarction
Recruiting
Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men
Exercise, Overreaching
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasily A Isakov, M.D., Ph.D. principal investigator
Russian Institute of Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multivitamin multimineral with phytonutrient supplementation in people with Heart Health Markers and General Nutritional Status, run by Access Business Group at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.