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NCT06151405 | RECRUITING | Asthma

Nutrition for Asthmatics
Sponsor:

Pennington Biomedical Research Center

Information provided by (Responsible Party):

Jacob T. Mey, PhD RD

Brief Summary:

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

Condition or disease

Asthma

Intervention/treatment

DGA Diet

MCT Diet

KETO Diet

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : QUADRUPLE
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.
Primary Purpose : TREATMENT
Official Title : Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)
Actual Study Start Date : 2024-07-17
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Nutrition for Asthmatics

Location Details

NCT06151405

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808