Healthy Eating Better Breathing: A Feeding Study in Patients With Asthma

NCT02904655 | Completed

• 1 other identifier: NA_00071879
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a randomized, crossover meal-replacement pilot intervention to determine feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week washout period. During the dietary intervention, all meals and snacks were provided by the study.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Feasibility as assessed by the number of participant drop outs

  Feasibility will be assessed by the number of drop outs.

  Change from baseline and 4 weeks

• Adherence using 24 hour diet recall

  Adherence to the dietary intervention will be assessed using self-report of dietary intake via 24 hour dietary recall.

  Change from baseline to 4 weeks

• Adherence assessed by serum carotenoids

  Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.

  Change from baseline to 4 weeks

Secondary Outcomes (15)

• FEV1

  Difference between baseline and 4 weeks

• FEV1

  Difference between baseline and 2 weeks

• FVC

  Difference between baseline and 2 weeks

• FVC

  Difference between baseline and 4 weeks

• FEV1/FVC ratio

  Difference between baseline and 4 weeks

Study Arms (2)

healthy diet

ACTIVE COMPARATOR

Participants were provided all meals and snacks for four weeks. Menus were created to target a healthy diet high in unsaturated fats.

Other: healthy diet

control diet

NO INTERVENTION

Participants were instructed to consume their usual diet.

Interventions

healthy diet OTHER

Participants were provided meals and snacks for one month that represented a healthy diet that is high in unsaturated fats, approximating a Mediterranean diet

healthy diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-50, self-reported physician diagnosis and treatment for asthma within the 12 months prior to enrollment, stable asthma defined as no asthma exacerbation (emergency department visit, systemic steroid treatment, or urgent care visit) or respiratory infection in the 4 weeks prior to enrollment.

You may not qualify if:

• active smokers,pregnant or breastfeeding, using systemic corticosteroids or warfarin, had another major pulmonary diagnosis or significant systemic illness, reported excessive alcohol consumption (over 14 drinks per week or six or more drinks on one or more occasions per week), reported food allergy, or weighed over 350 pounds or changed weight by over ten pounds in the two months prior to screening

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Asthma

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share