Effects of Dietary Supplements on Response to Air Pollution

This study has been completed.
Sponsor:
Collaborator:
USANA Health Sciences, Inc
Information provided by (Responsible Party):
Michael Lefevre, Utah State University
ClinicalTrials.gov Identifier:
NCT01488656
First received: December 6, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Inflammation
Dietary Supplement: Placebo
Dietary Supplement: Antioxidant, anti-inflammatory dietary supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of an Antioxidant and Anti-inflammatory Dietary Supplement Pack on the Adverse Physiological Actions Associated With Acute PM2.5 Exposure

Resource links provided by NLM:


Further study details as provided by Utah State University:

Primary Outcome Measures:
  • Forced vital lung capacity (FVC) [ Time Frame: Six times over 3 months to coincide with high and low PM2.5 exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forced expiratory volume in first second (FEV1) [ Time Frame: Six times over 3 months to coincide with high and low PM2.5 exposure ] [ Designated as safety issue: No ]
  • Fractional exhaled nitric oxide (FeNO) [ Time Frame: Six times over 3 months to coincide with high and low PM2.5 exposure ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: Six times over 3 months to coincide with high and low PM2.5 exposure ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo dietary supplements
Visually identical inactive dietary supplement pack
Dietary Supplement: Placebo
7-pill placebo dietary packed visually identical to active dietary supplement
Experimental: Active dietary supplements
Combination of antioxidants, minerals, fish oil, proflavanol and vitamin D
Dietary Supplement: Antioxidant, anti-inflammatory dietary supplement
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
Other Names:
  • USANA Mega Antioxidant
  • USANA Chelated Mineral
  • USANA Proflavanol C 200
  • USANA Vitamin D

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488656

Sponsors and Collaborators
Utah State University
USANA Health Sciences, Inc
Investigators
Principal Investigator: Michael Lefevre, PhD Utah State University
  More Information

No publications provided

Responsible Party: Michael Lefevre, USTAR Professor, Utah State University
ClinicalTrials.gov Identifier: NCT01488656     History of Changes
Other Study ID Numbers: USU #4001, 4011
Study First Received: December 6, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Utah State University:
Antioxidants
Dietary supplements
Forced vital lung capacity
Exhaled nitric oxide
Air pollution

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Vitamin D
Vitamins
Antioxidants
Anti-Inflammatory Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014