Nutrition for Asthmatics With Obesity

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05222451

Collaborator

The Cleveland Clinic (Other)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma Obesity	Other: DGA Diet Other: MCT Diet Other: KETO Diet	N/A

Detailed Description

This is a crossover design pilot trial that will recruit 12 adults with obesity and 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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

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:

Other

Official Title:

Nutritional Strategies to Enhance Lung Function in Asthmatics With Obesity

Actual Study Start Date :

Jun 27, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary Guidelines for Americans 7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).	Other: DGA Diet A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: A variety of vegetables and fruits Grains, at least half of which are whole grains Fat-free or low-fat dairy A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
Experimental: Medium Chain Triglyceride Supplemented DGA 7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).	Other: MCT Diet A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Experimental: Ketogenic Diet 7 days of a ketogenic diet (KETO).	Other: KETO Diet A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Arm

Intervention/Treatment

Experimental: Dietary Guidelines for Americans

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

Other: DGA Diet

A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: A variety of vegetables and fruits Grains, at least half of which are whole grains Fat-free or low-fat dairy A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.

Experimental: Medium Chain Triglyceride Supplemented DGA

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

Other: MCT Diet

A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).

Experimental: Ketogenic Diet

7 days of a ketogenic diet (KETO).

Other: KETO Diet

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Outcome Measures

Primary Outcome Measures

Asthma Control [Baseline]
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control [After 7 days on Diet#1]
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control [After 7 days on Diet#2]
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control [After 7 days on Diet#3]
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

Secondary Outcome Measures

Lung Function [Baseline]
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function [After 7 days on Diet#1]
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function [After 7 days on Diet#2]
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function [After 7 days on Diet#3]
FEV1 (forced expiratory volume in 1 second; % of predicted)
FENO [Baseline]
FENO (ppm)
FENO [After 7 days on Diet#1]
FENO (ppm)
FENO [After 7 days on Diet#2]
FENO (ppm)
FENO [After 7 days on Diet#3]
FENO (ppm)
FEV1/FVC [Baseline]
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC [After 7 days on Diet#1]
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC [After 7 days on Diet#2]
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC [After 7 days on Diet#3]
FEV1/Forced Vital Capacity (FVC) ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 18-65 years
BMI: 30-45 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

Pennington Biomedical Research Center
The Cleveland Clinic

Investigators

Principal Investigator: Jacob T Mey, PhD, RD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jacob T. Mey, PhD RD, Principal Investigator, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT05222451

Other Study ID Numbers:

PBRC - Diet for Asthma

First Posted:

Feb 3, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jacob T. Mey, PhD RD, Principal Investigator, Pennington Biomedical Research Center

ketone

diet

metabolism

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jul 29, 2022