search
Back to results

Nutrition for Asthmatics With Obesity

Primary Purpose

Asthma, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DGA Diet
MCT Diet
KETO Diet
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring ketone, diet, metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dietary Guidelines for Americans

Medium Chain Triglyceride Supplemented DGA

Ketogenic Diet

Arm Description

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

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

7 days of a ketogenic diet (KETO).

Outcomes

Primary Outcome Measures

Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Asthma Control
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.

Secondary Outcome Measures

Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
Lung Function
FEV1 (forced expiratory volume in 1 second; % of predicted)
FENO
FENO (ppm)
FENO
FENO (ppm)
FENO
FENO (ppm)
FENO
FENO (ppm)
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio
FEV1/FVC
FEV1/Forced Vital Capacity (FVC) ratio

Full Information

First Posted
January 5, 2022
Last Updated
April 3, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05222451
Brief Title
Nutrition for Asthmatics With Obesity
Official Title
Nutritional Strategies to Enhance Lung Function in Asthmatics With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity
Keywords
ketone, diet, metabolism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary Guidelines for Americans
Arm Type
Experimental
Arm Description
7 days of a diet consistent with the Dietary Guidelines for Americans (DGA).
Arm Title
Medium Chain Triglyceride Supplemented DGA
Arm Type
Experimental
Arm Description
7 days of a diet consistent with the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm Description
7 days of a ketogenic diet (KETO).
Intervention Type
Other
Intervention Name(s)
DGA Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MCT Diet
Intervention Description
A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
Intervention Type
Other
Intervention Name(s)
KETO Diet
Intervention Description
A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
Primary Outcome Measure Information:
Title
Asthma Control
Description
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time Frame
Baseline
Title
Asthma Control
Description
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time Frame
After 7 days on Diet#1
Title
Asthma Control
Description
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time Frame
After 7 days on Diet#2
Title
Asthma Control
Description
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
Time Frame
After 7 days on Diet#3
Secondary Outcome Measure Information:
Title
Lung Function
Description
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time Frame
Baseline
Title
Lung Function
Description
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time Frame
After 7 days on Diet#1
Title
Lung Function
Description
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time Frame
After 7 days on Diet#2
Title
Lung Function
Description
FEV1 (forced expiratory volume in 1 second; % of predicted)
Time Frame
After 7 days on Diet#3
Title
FENO
Description
FENO (ppm)
Time Frame
Baseline
Title
FENO
Description
FENO (ppm)
Time Frame
After 7 days on Diet#1
Title
FENO
Description
FENO (ppm)
Time Frame
After 7 days on Diet#2
Title
FENO
Description
FENO (ppm)
Time Frame
After 7 days on Diet#3
Title
FEV1/FVC
Description
FEV1/Forced Vital Capacity (FVC) ratio
Time Frame
Baseline
Title
FEV1/FVC
Description
FEV1/Forced Vital Capacity (FVC) ratio
Time Frame
After 7 days on Diet#1
Title
FEV1/FVC
Description
FEV1/Forced Vital Capacity (FVC) ratio
Time Frame
After 7 days on Diet#2
Title
FEV1/FVC
Description
FEV1/Forced Vital Capacity (FVC) ratio
Time Frame
After 7 days on Diet#3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob T Mey, PhD, RD
Phone
225-763-2644
Email
jacob.mey@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John P Kirwan, PhD
Phone
225-763-2644
Email
john.kirwan@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob T Mey, PhD, RD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Executive Director
Phone
225-763-2513

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study data will be provided upon request and approval by study PI.

Learn more about this trial

Nutrition for Asthmatics With Obesity

We'll reach out to this number within 24 hrs