Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
12

Summary

Conditions
Asthma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a randomized crossover pilot trial to evaluate the feasibility of a Western and prudent diet feeding study in Baltimore City adults with asthma.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Participants and nutrition staff will be aware of randomization assignments. All other study staff and the investigators will be blinded to assignment during the study.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

Description

The investigators are interested in the effects of two different diets on asthma health. The first, a prudent diet, consists of a high intake of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants (which may protect the lun...

The investigators are interested in the effects of two different diets on asthma health. The first, a prudent diet, consists of a high intake of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants (which may protect the lungs and the body against inflammation in patients with asthma). The second, a Western diet, consists of a high intake of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber (which may promote inflammation in the lungs and the body of patients with asthma). This pilot study will test the feasibility/acceptability of the study design in providing these two diets to participants over a short period of time (6 days per diet), and gather preliminary data on asthma health outcomes that will be used to design a larger, definitive trial. Each participant will be randomly (by chance, like flipping a coin) assigned to start with one of these diets. All foods in each of the diets will be supplied by the study, and participants will be expected to eat all of the food provided and only the food provided for the next 6 days. The investigators will make sure that each participant gets enough food for what their body needs, based on a visit with a nutritionist at the beginning of the study. After eating either the Prudent diet or Western diet for 6 days, participants will have a 4-8 week break (or washout period), during which they will eat their usual diet. Then participants will begin the alternate dietary intervention (Prudent or Western) for another 6 days, depending on which they received first. Before and after each dietary period, researchers will ask questions, check lung function, and collect samples from participants to determine acceptability of the meals and study design, gather feedback on the intervention and overall study structure, assess for changes in lung health and asthma control, measure inflammation and oxidative stress in the lungs and systemic circulation, and evaluate changes in the airway and gut microbiome associated with the interventions that may influence the asthmatic response.

Tracking Information

NCT #
NCT03200522
Collaborators
  • National Institutes of Health (NIH)
  • University of Nebraska
Investigators
Principal Investigator: Emily Brigham, MD, MHS Johns Hopkins University