Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Dietary Supplement: Ascorbic AcidDietary Supplement: Fish OilDietary Supplement: Ascorbic Acid PlaceboDietary Supplement: Fish Oil Placebo
- Registration Number
- NCT01057615
- Lead Sponsor
- Indiana University
- 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.
- Detailed Description
The aim of this study is to extend previous findings that nutritional supplementation or dietary modification can ameliorate exercise-induced bronchoconstriction. It has been shown in separate studies that fish oil and ascorbic acid (vitamin C) individually protect against EIB by improving pulmonary function and reducing airway inflammation. The main aim of this study is to determine the comparative and additive effects of fish oil and ascorbic acid supplementation on EIB and airway inflammation in asthmatic individuals.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Fish Oil + Vitamin C Placebo Ascorbic Acid Placebo Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks. Fish Oil Placebo + Active Vitamin C Ascorbic Acid Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks. Fish Oil Placebo + Active Vitamin C Fish Oil Placebo Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks. Active Fish Oil + Active Vitamin C Fish Oil 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. Active Fish Oil + Active Vitamin C Ascorbic Acid 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. Active Fish Oil + Vitamin C Placebo Fish Oil Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.
- Primary Outcome Measures
Name Time Method Pulmonary Function 8 weeks
- Secondary Outcome Measures
Name Time Method Exhaled nitric oxide to measure airway inflammation 8 weeks
Trial Locations
- Locations (1)
Indiana University
🇺🇸Bloomington, Indiana, United States