InflammationNCT01488656
Effects of Dietary Supplements on Response to Air Pollution
A study testing Antioxidant, anti-inflammatory dietary supplement in people with Inflammation, run by Utah State University.
Trial summary
This study will determine if a comprehensive antioxidant/anti-inflammatory dietary supplement pack can offer protection against a decline in lung function and increase in inflammation and oxidative stress following acute exposure to particulate matter air pollution with a diameter <2.5 µm (PM2.5). Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Antioxidant, anti-inflammatory dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2012
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of any race or ethnicity
- Body Mass Index (BMI) between 19 - 34 kg/m2
- Non-smoking status
- Willing to consume assigned dietary supplements for 18 weeks.
Who cannot join
- BMI <19 or >34 kg/m2
- Uncontrolled hypertension defined as diastolic blood pressure >=95 mm Hg or systolic blood pressure >=160 mm Hg
- Documented presence of atherosclerotic disease and/or cardiopulmonary disease
- History of frequent falls
- History of drug or alcohol abuse
- History of unstable depression or mental illness within the last 6 months for which the PI believes could impact the participant's ability to comply with study requirements
Show all 11Show fewer
- Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start
- Participating in or planning to begin a weight loss diet during the study period
- Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
- Difficulty in swallowing pills
- Lifestyle or schedule incompatible with the study protocol
About this study
Official title: Effect of an Antioxidant and Anti-inflammatory Dietary Supplement Pack on the Adverse Physiological Actions Associated With Acute PM2.5 Exposure
This study will determine if a comprehensive antioxidant/anti-inflammatory dietary supplement pack can offer protection against a decline in lung function and increase in inflammation and oxidative stress following acute exposure to particulate matter air pollution with a diameter <2.5 µm (PM2.5).
The investigators hypothesis is a follows: Compared to an appropriate control, supplementation with a comprehensive antioxidant/anti-inflammatory dietary supplement pack for 18 weeks will: 1) reduce the decline in lung function following acute exposure to naturally occurring elevations in PM2.5 levels as measured by exhaled nitric oxide levels and forced vital lung capacity; and 2) reduce changes in pro-inflammatory cytokines following acute exposure to naturally occurring elevations in PM2.5 levels as measured by plasma levels of C-reactive protein.
Read the detailed description
The study will be conducted in Cache County, UT. Surrounded by tall mountains (2513-3042 m), and subject to frequent winter atmospheric inversions characterized by stagnant air that traps and concentrates pollutants, Cache Valley, home to 120,000 inhabitants, is particularly susceptible to high particulate air pollution during the winter months.
A total of 70 individuals (with the goal of completing 60) between the ages of 45-80 will be recruited from Cache County, UT. Eligible participants will be randomly assigned to one of two treatment arms (Placebo Dietary Supplements, Active Dietary Supplements) in a manner to provide balanced assignment between the two arms with respect to age, sex and baseline exhaled nitric oxide levels.
Participants assigned to the Placebo or Active arms will be provided with sealed envelopes or bottles containing dietary supplements (or matched placebos) along with instructions as to when to consume the supplements. Participants will be instructed to consume their supplements twice a day with meals containing a small amount of fat (at least 3 grams) in order to optimize the absorption of fat soluble nutrients. They will also be instructed to consume the supplements with liquids in order to enhance absorption and to minimize GI upset and choking potential. Participants will be asked to maintain their typical diet for the 18 weeks of the study.
Routine Clinic Visits are scheduled at two week intervals for the length of the study (with accommodations made for Holiday schedules). During these visits, participants will: 1) receive a sufficient supply of supplements to last until the next routine clinic visit; 2) return any unused supplements; 3) be provided an opportunity to describe any adverse events/reactions to the supplements; 4) describe any health issues experienced since the previous exam; and 5) have their weight and blood pressure assessed.
Endpoint Clinic Visits are scheduled to coincide with low and high PM2.5 exposure. Starting on Jan 2, participants will be notified of a potential endpoint assessment day when the PM2.5 levels are predicted by the Utah Department of Environmental Quality, Division of Air Quality, to rise above 30 µg/m3 (peak event) or fall below 8 µg/m3 (baseline event). Endpoint visits will take place 24 hrs following these peak and baseline events. Based on historical patterns, we anticipate at least three peak events, with corresponding baseline assessments, during the intervention time period. For purposes of analysis, each peak event will be paired with the nearest baseline event so that both events are captured at a similar time after initiation of the intervention.
At each endpoint clinic visit, participants will undergo assessments of lung function and systemic inflammation. Blood samples will be obtained for potential future analysis of additional markers of systemic inflammation and plasma antioxidant capacity.
- Conditions
- Inflammation
- Being tested
- Placebo, Antioxidant, anti-inflammatory dietary supplement
- Keywords
- Antioxidants, Dietary supplements, Forced vital lung capacity, Exhaled nitric oxide, Air pollution
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
7-pill placebo dietary packed visually identical to active dietary supplement
Antioxidant, anti-inflammatory dietary supplementDietary supplement
Also called USANA Mega Antioxidant, USANA Chelated Mineral, USANA Proflavanol C 200, USANA Vitamin D
A combination of dietary supplements including: β-carotene, vitamin C, vitamin D3, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, boron, silicon, vanadium, eicosapentaenoic acid, docosahexaenoic acid, olive extract, mixed tocopherols, bioflavonoids, inositol, choline, N-acetyl L-cysteine, bromelain, coenzyme Q10, turmeric extract, lutein, lycopene, broccoli concentrate, grape seed extract
| Study group | Role | What they receive |
|---|---|---|
| Placebo dietary supplements | Placebo comparator | Visually identical inactive dietary supplement pack Receives: Dietary Supplement: Placebo |
| Active dietary supplements | Experimental | Combination of antioxidants, minerals, fish oil, proflavanol and vitamin D Receives: Dietary Supplement: Antioxidant, anti-inflammatory dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital lung capacity (FVC)
Measured: Six times over 3 months to coincide with high and low PM2.5 exposure
Secondary outcomes (3)
Forced expiratory volume in first second (FEV1)
Measured: Six times over 3 months to coincide with high and low PM2.5 exposure
Fractional exhaled nitric oxide (FeNO)
Measured: Six times over 3 months to coincide with high and low PM2.5 exposure
C-reactive protein
Measured: Six times over 3 months to coincide with high and low PM2.5 exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Collaborators
- USANA Health Sciences
- Responsible party
- Principal investigator, Michael Lefevre, Utah State University
- Investigators
- Michael Lefevre, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488656
- Sponsor's protocol ID
- USU #4001
- Other IDs
- 4011
- Status last verified
- Aug 2012
- First submitted
- 6 Dec 2011
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Antioxidant and Anti-inflammatory Dietary Supplement Pack on the Adverse Physiological Actions Associated With Acute PM2.5 Exposure
- ClinicalTrials.gov ID
- NCT01488656
- Acronym / sponsor ID
- USU #4001
- Conditions
- Inflammation
- Keywords
- Antioxidants, Dietary supplements, Forced vital lung capacity, Exhaled nitric oxide, Air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Collaborators
- USANA Health Sciences
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Dec 2011 (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.
This study will determine if a comprehensive antioxidant/anti-inflammatory dietary supplement pack can offer protection against a decline in lung function and increase in inflammation and oxidative stress following acute exposure to particulate matter air pollution with a diameter <2.5 µm (PM2.5).
The investigators hypothesis is a follows: Compared to an appropriate control, supplementation with a comprehensive antioxidant/anti-inflammatory dietary supplement pack for 18 weeks will: 1) reduce the decline in lung function following acute exposure to naturally occurring elevations in PM2.5 levels as measured by exhaled nitric oxide levels and forced vital lung capacity; and 2) reduce changes in pro-inflammatory cytokines following acute exposure to naturally occurring elevations in PM2.5 levels as measured by plasma levels of C-reactive protein.
Detailed description
The study will be conducted in Cache County, UT. Surrounded by tall mountains (2513-3042 m), and subject to frequent winter atmospheric inversions characterized by stagnant air that traps and concentrates pollutants, Cache Valley, home to 120,000 inhabitants, is particularly susceptible to high particulate air pollution during the winter months.
A total of 70 individuals (with the goal of completing 60) between the ages of 45-80 will be recruited from Cache County, UT. Eligible participants will be randomly assigned to one of two treatment arms (Placebo Dietary Supplements, Active Dietary Supplements) in a manner to provide balanced assignment between the two arms with respect to age, sex and baseline exhaled nitric oxide levels.
Participants assigned to the Placebo or Active arms will be provided with sealed envelopes or bottles containing dietary supplements (or matched placebos) along with instructions as to when to consume the supplements. Participants will be instructed to consume their supplements twice a day with meals containing a small amount of fat (at least 3 grams) in order to optimize the absorption of fat soluble nutrients. They will also be instructed to consume the supplements with liquids in order to enhance absorption and to minimize GI upset and choking potential. Participants will be asked to maintain their typical diet for the 18 weeks of the study.
Routine Clinic Visits are scheduled at two week intervals for the length of the study (with accommodations made for Holiday schedules). During these visits, participants will: 1) receive a sufficient supply of supplements to last until the next routine clinic visit; 2) return any unused supplements; 3) be provided an opportunity to describe any adverse events/reactions to the supplements; 4) describe any health issues experienced since the previous exam; and 5) have their weight and blood pressure assessed.
Endpoint Clinic Visits are scheduled to coincide with low and high PM2.5 exposure. Starting on Jan 2, participants will be notified of a potential endpoint assessment day when the PM2.5 levels are predicted by the Utah Department of Environmental Quality, Division of Air Quality, to rise above 30 µg/m3 (peak event) or fall below 8 µg/m3 (baseline event). Endpoint visits will take place 24 hrs following these peak and baseline events. Based on historical patterns, we anticipate at least three peak events, with corresponding baseline assessments, during the intervention time period. For purposes of analysis, each peak event will be paired with the nearest baseline event so that both events are captured at a similar time after initiation of the intervention.
At each endpoint clinic visit, participants will undergo assessments of lung function and systemic inflammation. Blood samples will be obtained for potential future analysis of additional markers of systemic inflammation and plasma antioxidant capacity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo dietary supplements | Placebo comparator | Dietary Supplement: PlaceboVisually identical inactive dietary supplement pack |
| Active dietary supplements | Experimental | Dietary Supplement: Antioxidant, anti-inflammatory dietary supplementCombination of antioxidants, minerals, fish oil, proflavanol and vitamin D |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of any race or ethnicity
- Body Mass Index (BMI) between 19 - 34 kg/m2
- Non-smoking status
- Willing to consume assigned dietary supplements for 18 weeks.
Key exclusion criteria (11 listed)
- BMI <19 or >34 kg/m2
- Uncontrolled hypertension defined as diastolic blood pressure >=95 mm Hg or systolic blood pressure >=160 mm Hg
- Documented presence of atherosclerotic disease and/or cardiopulmonary disease
- History of frequent falls
- History of drug or alcohol abuse
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 |
|---|---|---|
| Placebo7-pill placebo dietary packed visually identical to active dietary supplement | Dietary supplement | Placebo dietary supplements |
| Antioxidant, anti-inflammatory dietary supplementAlso: USANA Mega Antioxidant, USANA Chelated Mineral, USANA Proflavanol C 200, USANA Vitamin DA combination of dietary supplements including: β-carotene, vitamin C, vitamin D3, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, boron, silicon, vanadium, eicosapentaenoic acid, docosahexaenoic acid, olive extract, mixed tocopherols, bioflavonoids, inositol, choline, N-acetyl L-cysteine, bromelain, coenzyme Q10, turmeric extract, lutein, lycopene, broccoli concentrate, grape seed extract | Dietary supplement | Active dietary supplements |
Primary outcome
Forced vital lung capacity (FVC)
Time frame: Six times over 3 months to coincide with high and low PM2.5 exposure
3 secondary outcomes
Forced expiratory volume in first second (FEV1)
Time frame: Six times over 3 months to coincide with high and low PM2.5 exposure
Fractional exhaled nitric oxide (FeNO)
Time frame: Six times over 3 months to coincide with high and low PM2.5 exposure
C-reactive protein
Time frame: Six times over 3 months to coincide with high and low PM2.5 exposure
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 15 Aug 2012.
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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.
Michael Lefevre, PhD principal investigator
Utah State University
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant, anti-inflammatory dietary supplement in people with Inflammation, run by Utah State University.
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 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Forced vital lung capacity (FVC) (time frame: Six times over 3 months to coincide with high and low PM2.5 exposure). 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 15 Aug 2012.