Specialized Diets for Asthma in Obesity

Overseen By Jacob T Mey, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Diabetes medications

Disqualifiers: Diabetes, COPD, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the effect of diet on asthma in individuals with obesity.

Research Team

Jacob T Mey, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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.

Inclusion Criteria

My asthma medication has not changed in the last 2 months.

BMI: 30-45 kg/m2

Owns a device compatible with ZEPHYRx platform

Exclusion Criteria

I do not have serious heart, lung, kidney, or liver diseases and my blood pressure is controlled.

I have diabetes or am taking medication that lowers my blood sugar.

My fasting blood sugar is 126 mg/dl or higher, or my triglycerides are 400 mg/dl or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in

Participants undergo a lead-in period before randomization

1 week

Treatment

Participants are randomized to a series of three, 7-day diets with a 7+ day washout period between each diet

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DGA Diet
• KETO Diet
• MCT Diet

Trial Overview 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.

Participant Groups

Group I: Medium Chain Triglyceride Supplemented DGA Experimental Treatment 1 Intervention

7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).

Group II: Ketogenic Diet Experimental Treatment 1 Intervention

7 days of a ketogenic diet (KETO).

Group III: Dietary Guidelines for Americans Experimental Treatment 1 Intervention

7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).

DGA Diet is already approved in United States for the following indications:

Approved in United States as Dietary Guidelines for Americans for:

• General health and wellness
• Chronic disease prevention
• Weight management

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+