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Specialized Diets for Asthma in Obesity

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
Age: 18-65 years
Asthma diagnosed by medical specialist (confirmed in medical history)
Must not have
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
Diabetes or using diabetes medications that may lower blood glucose levels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 7 days on diet#3
Awards & highlights
No Placebo-Only Group

Summary

This trial will see if a certain diet can help improve asthma in obese people.

Who is the study for?
This trial is for adults aged 18-65 with obesity (BMI: 30-45 kg/m2) and partly controlled or uncontrolled asthma. Participants must have a stable asthma medication routine, no significant changes in the past two months, and be able to use the ZEPHYRx platform. Smokers, those with certain medical conditions like COPD or uncontrolled hypertension, pregnant/nursing women, diabetics on glucose-lowering meds, or individuals with food preferences/allergies that conflict with study diets cannot join.
What is being tested?
The study explores how different diets affect asthma control in obese individuals. Three specific diets are being tested: DGA Diet (based on Dietary Guidelines for Americans), MCT Diet (medium-chain triglycerides focused), and KETO Diet (very low-carb, high-fat). The goal is to see if these dietary approaches can improve asthma symptoms.
What are the potential side effects?
Potential side effects from diet changes may include gastrointestinal discomfort such as constipation or diarrhea due to shifts in fiber intake; fatigue during initial adjustment periods; possible nutrient deficiencies depending on diet adherence; and potential alterations in blood lipid levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with asthma by a specialist.
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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 diseases and my blood pressure is controlled.
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I have diabetes or am taking medication that lowers my blood sugar.
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I currently smoke or have smoked more than 10 pack-years.
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My fasting blood sugar is 126 mg/dl or higher, or my triglycerides are 400 mg/dl or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 7 days on diet#3
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Secondary study objectives
FENO
FEV1/FVC
Lung Function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
309 Previous Clinical Trials
179,906 Total Patients Enrolled
1 Trials studying Asthma
15 Patients Enrolled for Asthma
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,748 Total Patients Enrolled
9 Trials studying Asthma
3,623 Patients Enrolled for Asthma
Jacob T Mey, PhD, RDPrincipal InvestigatorPennington Biomedical Research Center
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Asthma
15 Patients Enrolled for Asthma

Media Library

DGA Diet Clinical Trial Eligibility Overview. Trial Name: NCT05222451 — N/A
Asthma Research Study Groups: Ketogenic Diet, Dietary Guidelines for Americans, Medium Chain Triglyceride Supplemented DGA
Asthma Clinical Trial 2023: DGA Diet Highlights & Side Effects. Trial Name: NCT05222451 — N/A
DGA Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222451 — N/A
~0 spots leftby Dec 2024
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