Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

NCT01057615 | Completed Phase 1

• 1 other identifier: 0910000751
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.

Conditions

Asthma

Keywords

Asthma; Exercise-Induced Bronchoconstriction; Inflammation; Airway; Fish Oil; Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function

  8 weeks

Secondary Outcomes (1)

• Exhaled nitric oxide to measure airway inflammation

  8 weeks

Study Arms (3)

Active Fish Oil + Vitamin C Placebo

EXPERIMENTAL

Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.

Dietary Supplement: Fish Oil; Dietary Supplement: Ascorbic Acid Placebo

Fish Oil Placebo + Active Vitamin C

EXPERIMENTAL

Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.

Dietary Supplement: Ascorbic Acid; Dietary Supplement: Fish Oil Placebo

Active Fish Oil + Active Vitamin C

EXPERIMENTAL

Following a 2-week washout period, all subjects from the other two arms (n=30) will take 10 active fish oil capsules per day and 2 active vitamin C capsules per day for 3 weeks.

Dietary Supplement: Fish Oil; Dietary Supplement: Ascorbic Acid

Interventions

Fish Oil DIETARY_SUPPLEMENT

10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks

Active Fish Oil + Active Vitamin C; Active Fish Oil + Vitamin C Placebo

Ascorbic Acid DIETARY_SUPPLEMENT

2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks

Also known as: Vitamin C

Active Fish Oil + Active Vitamin C; Fish Oil Placebo + Active Vitamin C

Fish Oil Placebo DIETARY_SUPPLEMENT

10 placebo fish oil (soy bean oil) capsules per day for 3 weeks

Also known as: Soy Bean Oil

Fish Oil Placebo + Active Vitamin C

Ascorbic Acid Placebo DIETARY_SUPPLEMENT

2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks

Also known as: Table Sugar

Active Fish Oil + Vitamin C Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
• Diagnosis of EIB, based on ≥10% fall in post-challenge FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
• Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
• Not currently taking any fish oil or ascorbic acid supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
• Agree to limit fish consumption to 1 fish meal per week throughout the study
• Agree to avoid vitamin C-rich foods throughout the study

You may not qualify if:

• Resting FEV1 (the amount of air blown out in the first second of a forced exhalation) \<60% of predicted when off medication
• Pregnancy
• History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
• History of bleeding disorders or delayed clotting time
• History of diabetes
• History of seizures
• Allergy to fish oil or ascorbic acid (vitamin C)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Related Publications (3)

• Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

  PMID: 12904324 BACKGROUND

• Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.

  PMID: 16424411 BACKGROUND

• Tecklenburg SL, Mickleborough TD, Fly AD, Bai Y, Stager JM. Ascorbic acid supplementation attenuates exercise-induced bronchoconstriction in patients with asthma. Respir Med. 2007 Aug;101(8):1770-8. doi: 10.1016/j.rmed.2007.02.014. Epub 2007 Apr 5.

  PMID: 17412579 BACKGROUND

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Fish Oils; Ascorbic Acid; Soybean Oil; Dietary Sucrose

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Sugars; Dietary Carbohydrates; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Timothy D Mickleborough, PhD

  Indiana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 31, 2011

Record last verified: 2011-01

Locations

US (1)