Metabolic SyndromeNCT03488992
Effect of a MVM Dietary Supplement on Indices of Human Health
A study testing MVM/phytochemical supplement in people with Metabolic Syndrome, run by USANA Health Sciences at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the health benefits of a recently developed multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This newly developed supplement - an advancement of a previous formula designed to enhance human health by providing RDA-levels of essential… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- MVM/phytochemical supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2017to 25 Feb 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index of 29.9 to 40 kg/m2 ±1 kg/m2
- Waist measurement for males ≥ 102 cm (40 inches) or for females ≥ 89 cm (35 inches)
- two or more of the following risk factors:
- Elevated blood pressure ( 130/85 mm Hg)
- Fasting elevated triglycerides > 1.69 mmol/L ( 150 mg/dL)
- Elevated fasting glucose > 5.56 mmol/L ( 100 mg/dL) and <7.0 mmol/L (<126 mg/dL)
- Low HDL cholesterol <1.29 mmol/L ( 50 mg/dL) for females, and <1.03 mmol/L ( 40 mg/dL) for males
- Not currently taking a multivitamin/mineral, antioxidant supplement, or other dietary supplements or are willing to wash out for 4 weeks before enrollment
Who cannot join
- Pregnant and/ or lactating females or females trying to become pregnant
- Use of lipid lowering medications
- Lipid lowering OTC or herbal supplements within 3 weeks of enrollment
- Use of conventional multivitamin/mineral, antioxidant supplements or other dietary supplements within four weeks prior to enrollment
- Insulin-dependent Type I and Type II diabetics
- Diabetic men > 45 years and diabetic women > 55 years
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- Metformin or other diabetes medications are prohibited in this study
- Type II diabetes controlled by diet and/or exercise
- Elevated blood pressure ( 160/95 mm Hg) at screening
- Individuals with a history of coronary artery disease, previous myocardial infarction, peripheral vascular disease, or atherosclerosis
- Men above 50 years and women above 60 years who have a 10-year risk of cardiovascular event FRS between 10% and 19% (inclusive) at screening and who present with one of the following LDL-C > 3.5 mmol/L, TC/HDL-C ratio > 5.0, or hs-CRP > 2 mg/L
- Individuals with a 10-year risk of cardiovascular event FRS < 10% at screening and present with LDL-C > 5.0 mmol/L or TC/HDL-C ratio > 6.0
- Participants taking blood thinners
- Participants with stomach ulcers, gall stones, or bile duct obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
The purpose of this study is to investigate the health benefits of a recently developed multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This newly developed supplement - an advancement of a previous formula designed to enhance human health by providing RDA-levels of essential vitamins and minerals - contains eight phytochemicals selected to address fruit and vegetable undernutrition, and chosen on the basis that: 1) published research from cell culture, animal model and, when available, human clinical work, suggests that it may benefit human health, and 2) it is considered safe for human ingestion at proposed levels of consumption.
Read the detailed description
This study will be an eight-week, randomized, placebo controlled, parallel arm clinical trial to compare markers of nutritional, inflammatory and oxidative status, cardiovascular and neurological health as well as microbial status in subjects consuming a novel multivitamin/multimineral/phytochemical (MVM/phytochemical) supplement compared to subjects consuming a placebo tablet. In addition, this study will evaluate whether the MVM/phytochemical supplement improves subjects sense of well-being as evaluated by a quality-of-life survey. The study will aim to enroll 112 consenting men and women characterized as having metabolic syndrome. Potential subjects will be recruited through flyers, newspapers and advertisements placed throughout the community. Consented subjects will undergo a 28-day washout, followed by a 56-day trial period. Biological samples (blood, urine, stool, saliva) will be collected at baseline (day 0) and at day 56. Diet and exercise history, as well as a quality of life survey, will be collected at these time points as well. Risk to participants is expected to be minimal and will be outlined through an informed consent.
- Conditions
- Metabolic Syndrome
- Being tested
- MVM/phytochemical supplement, Placebo
- Keywords
- dietary supplement, cardiovascular health, oxidative stress
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVM/phytochemical supplementDietary supplement
Consumption of an MVM/phytochemical supplement for 8 weeks
PlaceboDietary supplement
Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
| Study group | Role | What they receive |
|---|---|---|
| MVM/phytochemical supplement | Experimental | a multi-vitamin, multi-mineral, phytochemical supplement Receives: Dietary Supplement: MVM/phytochemical supplement |
| Placebo | Placebo comparator | a placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL Cholesterol
Effect of MVM/Phytochemical Supplement on HDL-cholesterol levels compared to placebo
Measured: 8 weeks
Secondary outcomes (7)
Inflammation
change in inflammatory markers between MVM/Phytochemical Supplement and placebo including circulating levels of IL-1b, TNF-a, and IFNg
Measured: 8 weeks
Oxidative Stress
change in oxidative stress markers between MVM/Phytochemical Supplement and placebo including antioxidant enzyme activity (SOD, Catalase, GSH-Px) and markers of oxidative stress (GSH/GSSG, 8-isoprostanes)
Measured: 8 weeks
Cardiovascular Health
change in markers of cardiovascular health between MVM/Phytochemical including Cholesterol levels Supplement and placebo (LDL, HDL, total cholesterol, homocysteine)
Measured: 8 weeks
Nutritional status
change in markers of nutritional status between MVM/Phytochemical Supplement and placebo including vitamins A,D,E,K,C,B6,B12 and folate)
Measured: 8 weeks
Neurological Health
change in markers of neurological health between MVM/Phytochemical Supplement and placebo
Measured: 8 weeks
Microbiome
change in microbiome between MVM/Phytochemical Supplement and placebo using 16s analysis
Measured: 8 weeks
Quality of Life
difference in self-perceived quality of life between MVM/Phytochemical Supplement and placebo using the SF-36 questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start10 Jan 2017
- Primary completion25 Feb 2018
- Study completion25 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Mark Levy, Principal investigator, USANA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488992
- Sponsor's protocol ID
- 16MHHU
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
- ClinicalTrials.gov ID
- NCT03488992
- Acronym / sponsor ID
- 16MHHU
- Conditions
- Metabolic Syndrome
- Keywords
- dietary supplement, cardiovascular health, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 5 Apr 2018 (actual)
- 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 purpose of this study is to investigate the health benefits of a recently developed multimineral/multivitamin/phytochemical (MVM/phytochemical) nutritional supplement. This newly developed supplement - an advancement of a previous formula designed to enhance human health by providing RDA-levels of essential vitamins and minerals - contains eight phytochemicals selected to address fruit and vegetable undernutrition, and chosen on the basis that: 1) published research from cell culture, animal model and, when available, human clinical work, suggests that it may benefit human health, and 2) it is considered safe for human ingestion at proposed levels of consumption.
Detailed description
This study will be an eight-week, randomized, placebo controlled, parallel arm clinical trial to compare markers of nutritional, inflammatory and oxidative status, cardiovascular and neurological health as well as microbial status in subjects consuming a novel multivitamin/multimineral/phytochemical (MVM/phytochemical) supplement compared to subjects consuming a placebo tablet. In addition, this study will evaluate whether the MVM/phytochemical supplement improves subjects sense of well-being as evaluated by a quality-of-life survey. The study will aim to enroll 112 consenting men and women characterized as having metabolic syndrome. Potential subjects will be recruited through flyers, newspapers and advertisements placed throughout the community. Consented subjects will undergo a 28-day washout, followed by a 56-day trial period. Biological samples (blood, urine, stool, saliva) will be collected at baseline (day 0) and at day 56. Diet and exercise history, as well as a quality of life survey, will be collected at these time points as well. Risk to participants is expected to be minimal and will be outlined through an informed consent.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVM/phytochemical supplement | Experimental | Dietary Supplement: MVM/phytochemical supplementa multi-vitamin, multi-mineral, phytochemical supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placeboa placebo tablet (microcrystalline cellulose) identical in size, shape and color to the treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body Mass Index of 29.9 to 40 kg/m2 ±1 kg/m2
- Waist measurement for males ≥ 102 cm (40 inches) or for females ≥ 89 cm (35 inches)
- two or more of the following risk factors:
- Not currently taking a multivitamin/mineral, antioxidant supplement, or other dietary supplements or are willing to wash out for 4 weeks before enrollment
Key exclusion criteria (14 listed)
- Pregnant and/ or lactating females or females trying to become pregnant
- Use of lipid lowering medications
- Lipid lowering OTC or herbal supplements within 3 weeks of enrollment
- Use of conventional multivitamin/mineral, antioxidant supplements or other dietary supplements within four weeks prior to enrollment
- Insulin-dependent Type I and Type II diabetics
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 |
|---|---|---|
| MVM/phytochemical supplementConsumption of an MVM/phytochemical supplement for 8 weeks | Dietary supplement | MVM/phytochemical supplement |
| PlaceboConsumption of a placebo tablet identical in size, shape and color to the treatment tablet | Dietary supplement | Placebo |
Primary outcome
HDL Cholesterol
Time frame: 8 weeks
Effect of MVM/Phytochemical Supplement on HDL-cholesterol levels compared to placebo
7 secondary outcomes
Inflammation
Time frame: 8 weeks
Oxidative Stress
Time frame: 8 weeks
Cardiovascular Health
Time frame: 8 weeks
Nutritional status
Time frame: 8 weeks
Neurological Health
Time frame: 8 weeks
Microbiome
Time frame: 8 weeks
Quality of Life
Time frame: 8 weeks
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 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Mark Levy principal investigator
USANA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MVM/phytochemical supplement in people with Metabolic Syndrome, run by USANA Health Sciences at 1 site in Canada.
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 8 inclusion and 14 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 5 Apr 2018. 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 Canada. 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?
HDL Cholesterol (time frame: 8 weeks). 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 5 Apr 2018.