HealthyNCT03146312
Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Indices of Human Health
A study testing MVM/phytochemical supplement in people with Healthy, run by USANA Health Sciences at 1 site in United States.
Trial summary
This is a global transcriptomics and epigenetic pilot study designed to identify changes in gene expression and DNA methylation patterns following the consumption of an MVM/phytochemical supplement in a small group of healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 8 Jun 2017
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide a signed Informed Consent prior to entry in the study.
- Are in generally good health.
- Comprehensive Metabolic Panel results reported within normal reference ranges
- Body Mass Index of 18.5 - 30.
- Systolic blood pressure of 90-130 mm Hg; diastolic blood pressure of 60-90 mm Hg.
- Fasting blood glucose from 65-110 mg/dl.
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- Total cholesterol level of <240 mg/dl
- LDL cholesterol of <130 mg/dl
- Triglyceride level of <150 mg/dl.
- Have good venous access.
- Must be able to swallow tablets and pills
Who cannot join
- Pregnant, trying to become pregnant, or breast feeding.
- Chronic or acute use of prescription or OTC medications that may interfere with absorption of the test supplement.
- Consumption of a multivitamin/mineral or other dietary supplement for more than 5 days within 30 days of the screening visit.
- Gastrointestinal conditions that may affect consumption of the treatment or placebo tablets.
- insulin-dependent and orally controlled diabetics
- Scheduling difficulties or lack of transportation
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- Have participated as a subject in any other clinical study within 30 days of the screening visit
- A history of alcohol or substance abuse within 2 years
- Significant constipation or diarrhea
- Allergies or intolerance to turmeric, curcumin or related products
- Inability or difficulty swallowing tablets and pills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Multivitamin/Multimineral/Phytochemical Dietary Supplement on Gene Expression, Epigenetics and Nutritional Status in Healthy Adults
This is a global transcriptomics and epigenetic pilot study designed to identify changes in gene expression and DNA methylation patterns following the consumption of an MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms underlying the health benefits associated with MVM/phytochemical supplementation.
Read the detailed description
There is considerable controversy regarding the benefit of widespread dietary supplement use, in particular widespread MVM use. The controversy persists because of a marked incongruity in nutrition research: on one hand, many studies indicate that MVM supplement consumption yields few - if any - demonstrable health benefits, yet on the other hand, numerous findings indicate most Americans do not consume the RDA of a variety of nutrients, particularly vitamins and minerals, and are becoming increasingly under-nourished. Nutrigenomics offers a unique opportunity to address this controversy, as it can identify subtle changes in gene expression and epigenetic signatures immediately following a nutritional intervention - changes which may be indicative of improved health status and which may otherwise remain undetectable through other clinical endpoints for a considerable period of time, even into future generations.
Hypothesis: The investigators hypothesize that MVM/phytochemical supplementation will result in transcriptional and epigenetic changes consistent with an enhancement in human health status. Moreover, the investigators hypothesize that MVM/phytochemical supplementation will alter markers of cardiovascular, antioxidant, nutritional as well as inflammatory status in a manner indicative of improved health.
Study Design:
This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 4-week period. 50-60 healthy subjects will be recruited and, if eligible for the study, matched by age, sex and ethnicity and randomized in a 1:1 ratio to either of two interventions:
- Daily consumption of the control supplement (placebo)
- Daily consumption of the MVM/phytochemical supplement (treatment)
Methods:
Blood will be collected at baseline and after the 4-week intervention. At each time point, PBMCs will be collected, and DNA and RNA extracted for genome-wide gene expression and DNA methylation analyses. Serum and plasma will also be collected in order to assess clinical markers related to cardiovascular, nutritional, antioxidant and inflammatory status.
- Conditions
- Healthy
- Being tested
- MVM/phytochemical supplement, Placebo
- Keywords
- gene expression, gene array, epigenetics, DNA methylation
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 4 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.
Gene expression
Gene expression measured by microarray
Measured: 4 weeks
Secondary outcomes (5)
Inflammation
change in inflammatory markers between MVM/Phytochemical Supplement and placebo
Measured: 4 weeks
Cardiovascular Health
change in markers of cardiovascular health between MVM/Phytochemical Supplement and placebo
Measured: 4 weeks
Nutritional status
change in markers of nutritional status between MVM/Phytochemical Supplement and placebo
Measured: 4 weeks
Oxidative stress/Antioxidant Status
change in oxidative stress markers between MVM/Phytochemical Supplement and placebo
Measured: 4 weeks
Epigenetics
Changes in DNA methylation patterns
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start20 Apr 2017
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Levy, PhD, Principal investigator, USANA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146312
- Sponsor's protocol ID
- 201773
- Status last verified
- Mar 2018
- First submitted
- 5 May 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 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 Gene Expression, Epigenetics and Nutritional Status in Healthy Adults
- ClinicalTrials.gov ID
- NCT03146312
- Acronym / sponsor ID
- 201773
- Conditions
- Healthy
- Keywords
- gene expression, gene array, epigenetics, DNA methylation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 9 May 2017 (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.
This is a global transcriptomics and epigenetic pilot study designed to identify changes in gene expression and DNA methylation patterns following the consumption of an MVM/phytochemical supplement in a small group of healthy subjects. We hypothesize that genome-wide transcriptional and epigenetic studies will elucidate the molecular mechanisms underlying the health benefits associated with MVM/phytochemical supplementation.
Detailed description
There is considerable controversy regarding the benefit of widespread dietary supplement use, in particular widespread MVM use. The controversy persists because of a marked incongruity in nutrition research: on one hand, many studies indicate that MVM supplement consumption yields few - if any - demonstrable health benefits, yet on the other hand, numerous findings indicate most Americans do not consume the RDA of a variety of nutrients, particularly vitamins and minerals, and are becoming increasingly under-nourished. Nutrigenomics offers a unique opportunity to address this controversy, as it can identify subtle changes in gene expression and epigenetic signatures immediately following a nutritional intervention - changes which may be indicative of improved health status and which may otherwise remain undetectable through other clinical endpoints for a considerable period of time, even into future generations.
Hypothesis: The investigators hypothesize that MVM/phytochemical supplementation will result in transcriptional and epigenetic changes consistent with an enhancement in human health status. Moreover, the investigators hypothesize that MVM/phytochemical supplementation will alter markers of cardiovascular, antioxidant, nutritional as well as inflammatory status in a manner indicative of improved health.
Study Design:
This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 4-week period. 50-60 healthy subjects will be recruited and, if eligible for the study, matched by age, sex and ethnicity and randomized in a 1:1 ratio to either of two interventions:
- Daily consumption of the control supplement (placebo)
- Daily consumption of the MVM/phytochemical supplement (treatment)
Methods:
Blood will be collected at baseline and after the 4-week intervention. At each time point, PBMCs will be collected, and DNA and RNA extracted for genome-wide gene expression and DNA methylation analyses. Serum and plasma will also be collected in order to assess clinical markers related to cardiovascular, nutritional, antioxidant and inflammatory status.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, 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
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide a signed Informed Consent prior to entry in the study.
- Are in generally good health.
- Comprehensive Metabolic Panel results reported within normal reference ranges
- Body Mass Index of 18.5 - 30.
- Systolic blood pressure of 90-130 mm Hg; diastolic blood pressure of 60-90 mm Hg.
Key exclusion criteria (11 listed)
- Pregnant, trying to become pregnant, or breast feeding.
- Chronic or acute use of prescription or OTC medications that may interfere with absorption of the test supplement.
- Consumption of a multivitamin/mineral or other dietary supplement for more than 5 days within 30 days of the screening visit.
- Gastrointestinal conditions that may affect consumption of the treatment or placebo tablets.
- insulin-dependent and orally controlled 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 4 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
Gene expression
Time frame: 4 weeks
Gene expression measured by microarray
5 secondary outcomes
Inflammation
Time frame: 4 weeks
Cardiovascular Health
Time frame: 4 weeks
Nutritional status
Time frame: 4 weeks
Oxidative stress/Antioxidant Status
Time frame: 4 weeks
Epigenetics
Time frame: 4 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 30 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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, PhD 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 Healthy, run by USANA Health Sciences at 1 site in United States.
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 11 inclusion and 11 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 30 Mar 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 United States. 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?
Gene expression (time frame: 4 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 30 Mar 2018.