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Purpose

Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age: 18-65 years - BMI: 18.5 - 29.99 kg/m2 - asthma diagnosed by medical specialist (confirmed in medical history) - partly controlled or uncontrolled asthma by Asthma Control Test score ≤22 - owns a device compatible with ZEPHYRx platform - stable asthma medication use (no change in the past 2 months).

Exclusion Criteria

  • Diabetes or using diabetes medications that may lower blood glucose levels - point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl - current smoking or smoking history of greater than 10 pack-years - other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg - pregnant or nursing women - food preferences or allergies inconsistent with study diet capabilities - noncompliance with lead-in period requirements.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants will not be made aware of the diet allocation. However, due inherent differences in macronutrient content of the diets, participants may perceive differences in the quantity of various food groups or in the taste, texture or smell of foods present in the diet. To address this, diets will be designed to minimize noticeable differences for the participant. The investigator and outcomes assessor will remain fully masked to diet provision.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dietary Guidelines for Americans 		7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).
  • Other: DGA Diet
    A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: - A variety of vegetables and fruits - Grains, at least half of which are whole grains - Fat-free or low-fat dairy - A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds - This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
Experimental
Medium Chain Triglyceride Supplemented DGA 		7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
  • Other: MCT Diet
    A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Experimental
Ketogenic Diet 		7 days of a ketogenic diet (KETO).
  • Other: KETO Diet
    A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Recruiting Locations

Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
Contact:
Executive Director
225-763-2513

More Details

Status
Recruiting
Sponsor
Pennington Biomedical Research Center

Study Contact

Jacob T Mey, PhD, RD
225-763-2644
jacob.mey@pbrc.edu

Detailed Description

This is a crossover design pilot trial that will recruit 15 adults with asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet. The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.