Effects of Dietary Supplements on Response to Air Pollution

NCT01488656 | Completed

• 2 other identifiers: USU #40014011
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Inflammation

Keywords

Antioxidants; Dietary supplements; Forced vital lung capacity; Exhaled nitric oxide; Air pollution

Outcome Measures

Primary Outcomes (1)

• Forced vital lung capacity (FVC)

  Six times over 3 months to coincide with high and low PM2.5 exposure

Secondary Outcomes (3)

• Forced expiratory volume in first second (FEV1)

  Six times over 3 months to coincide with high and low PM2.5 exposure

• Fractional exhaled nitric oxide (FeNO)

  Six times over 3 months to coincide with high and low PM2.5 exposure

• C-reactive protein

  Six times over 3 months to coincide with high and low PM2.5 exposure

Study Arms (2)

Placebo dietary supplements

PLACEBO COMPARATOR

Visually identical inactive dietary supplement pack

Dietary Supplement: Placebo

Active dietary supplements

EXPERIMENTAL

Combination of antioxidants, minerals, fish oil, proflavanol and vitamin D

Dietary Supplement: Antioxidant, anti-inflammatory dietary supplement

Interventions

Placebo DIETARY_SUPPLEMENT

7-pill placebo dietary packed visually identical to active dietary supplement

Placebo dietary supplements

Antioxidant, anti-inflammatory dietary supplement 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

Also known as: USANA Mega Antioxidant, USANA Chelated Mineral, USANA Proflavanol C 200, USANA Vitamin D

Active dietary supplements

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Utah State University: lead
• USANA Health Sciences: collaborator

MeSH Terms

Conditions

Inflammation

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Michael Lefevre, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: USTAR Professor

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08