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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 7 days on diet#3
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma Control
Secondary outcome measures
FENO
FEV1/FVC
Lung Function

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
305 Previous Clinical Trials
182,024 Total Patients Enrolled
1 Trials studying Asthma
15 Patients Enrolled for Asthma
The Cleveland ClinicOTHER
1,029 Previous Clinical Trials
1,365,066 Total Patients Enrolled
8 Trials studying Asthma
2,153 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person meet in order to enroll in this trial?

"This research project is seeking 12 people with obesity to participate. The age range should be 18-65 years old and the Body Mass Index must be between 30-45kg/m2. Additionally, participants must have already been diagnosed by a medical specialist for asthma and their current Asthma Control Test score must not exceed 22 points. Furthermore, they are expected to possess compatible technology with ZEPHYRx platform as well as demonstrate stable utilization of medications over last two months (with no changes)."

Answered by AI

Does this research project still have open enrollment for volunteers?

"Affirmative, the details posted on clinicaltrials.gov suggest that this research is currently recruiting participants. The trial was initiated on June 27th 2022 and has been updated as recently as November 10th 2022. As of now, 12 individuals need to be sourced from a single medical centre."

Answered by AI

Does this clinical investigation accept participants who are 50 or older?

"This research seeks individuals aged between 18 and 65 to participate in the trial."

Answered by AI

What is the upper limit of study participants for this clinical trial?

"Yes, the public listing on clinicaltrials.gov presents evidence that this research endeavour is currently gathering participants. It was originally posted on June 27th 2022 and most recently revised on November 10th 2022. The trial requires 12 volunteers to be recruited from 1 medical centre."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
2
What site did they apply to?
Pennington Biomedical Research Center
Recent research and studies
clinicaltrials.govStudy
Nutrition for Asthmatics With Obesity
Jacob T. Mey, PhD RD 2022. "Nutrition for Asthmatics With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222451.
All > Pediatric Asthma > Diet
~0 spots leftby Apr 2024
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