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Specialized Diets for Asthma (INHALE Trial)

N/A
Recruiting
Led By Jacob T Mey, PhD, RD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Asthma diagnosed by medical specialist (confirmed in medical history)
Age: 18-65 years
Must not have
Other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease
Diabetes or using diabetes medications that may lower blood glucose levels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after 7 days on diet#1, after 7 days on diet#2, after 7 days on diet#3
Awards & highlights

Summary

This trial looks at diet's effect on asthma control & lung function.

Who is the study for?
This trial is for adults aged 18-65 with a BMI of 18.5-29.99 who have asthma diagnosed by a specialist and partly controlled or uncontrolled symptoms, as shown by an Asthma Control Test score ≤22. Participants must have stable asthma medication use and own a device compatible with the ZEPHYRx platform.
What is being tested?
The study aims to compare how three diets—MCT Diet, DGA Diet, and KETO Diet—affect asthma control and lung function in participants. It will determine which dietary approach may be most beneficial for improving health outcomes in asthmatics.
What are the potential side effects?
While not explicitly listed, potential side effects could include changes in weight, digestive discomfort or alterations in energy levels due to diet modifications. Specific side effects would depend on individual responses to each diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My asthma has been diagnosed by a specialist.
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I am between 18 and 65 years old.
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My asthma is partly or not controlled, with a score of 22 or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart, lung, kidney, or liver conditions.
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I have diabetes or am taking medication that lowers my blood sugar.
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My fasting blood sugar is 126 mg/dl or higher, or my triglycerides are 400 mg/dl or higher.
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I currently smoke or have smoked more than 10 pack-years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 7 days on diet#1, after 7 days on diet#2, after 7 days on diet#3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 7 days on diet#1, after 7 days on diet#2, after 7 days on diet#3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Asthma Control
Lung Function
Secondary study objectives
FENO
FEV1/FVC
Systemic inflammation
Other study objectives
eosinophilic asthma characterization
immunoglobulin asthma characterization
indirect calorimetry
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Medium Chain Triglyceride Supplemented DGAExperimental Treatment1 Intervention
7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Group II: Ketogenic DietExperimental Treatment1 Intervention
7 days of a ketogenic diet (KETO).
Group III: Dietary Guidelines for AmericansExperimental Treatment1 Intervention
7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
307 Previous Clinical Trials
181,146 Total Patients Enrolled
1 Trials studying Asthma
12 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,192 Total Patients Enrolled
280 Trials studying Asthma
114,173 Patients Enrolled for Asthma
Jacob T Mey, PhD, RDPrincipal InvestigatorPennington Biomedical Research Center
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Asthma
12 Patients Enrolled for Asthma
~10 spots leftby Dec 2026
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