Nutrition for Asthmatics with Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Asthma Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Dietary Guidelines for Americans

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

Group Type EXPERIMENTAL

DGA Diet

Intervention Type OTHER

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.

Medium Chain Triglyceride Supplemented DGA

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

Group Type EXPERIMENTAL

MCT Diet

Intervention Type OTHER

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

Ketogenic Diet

7 days of a ketogenic diet (KETO).

Group Type EXPERIMENTAL

KETO Diet

Intervention Type OTHER

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Interventions

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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.

Intervention Type OTHER

MCT Diet

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

Intervention Type OTHER

KETO Diet

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No