INHALE: Nutrition for Asthmatics

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06151405
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 15
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 37.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Determine to what extent three distinct dietary approaches improve asthma control and lung function.

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

Detailed Description

This is a crossover design pilot trial that will recruit 15 adults with 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: 15 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: Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)
• Anticipated Study Start Date: Jan 8, 2024
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Mar 1, 2027

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.

Outcome Measures

Primary Outcome Measures

1. Asthma Control [Baseline]

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

2. 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.

3. 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.

4. 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.

5. Lung Function [Baseline]

   FEV1 (forced expiratory volume in 1 second; % of predicted)

6. Lung Function [After 7 days on Diet#1]

   FEV1 (forced expiratory volume in 1 second; % of predicted)

7. Lung Function [After 7 days on Diet#2]

   FEV1 (forced expiratory volume in 1 second; % of predicted)

8. Lung Function [After 7 days on Diet#3]

   FEV1 (forced expiratory volume in 1 second; % of predicted)

Secondary Outcome Measures

1. Systemic inflammation [Baseline]

   plasma interleukin-6 (IL6)

2. Systemic inflammation [After 7 days on Diet#1]

   plasma interleukin-6 (IL6)

3. Systemic inflammation [After 7 days on Diet#2]

   plasma interleukin-6 (IL6)

4. Systemic inflammation [After 7 days on Diet#3]

   plasma interleukin-6 (IL6)

5. FENO [Baseline]

   FENO (ppm)

6. FENO [After 7 days on Diet#1]

   FENO (ppm)

7. FENO [After 7 days on Diet#2]

   FENO (ppm)

8. FENO [After 7 days on Diet#3]

   FENO (ppm)

9. FEV1/FVC [Baseline]

   FEV1/Forced Vital Capacity (FVC) ratio

10. FEV1/FVC [After 7 days on Diet#1]

    FEV1/Forced Vital Capacity (FVC) ratio

11. FEV1/FVC [After 7 days on Diet#2]

    FEV1/Forced Vital Capacity (FVC) ratio

12. FEV1/FVC [After 7 days on Diet#3]

    FEV1/Forced Vital Capacity (FVC) ratio

Other Outcome Measures

1. indirect calorimetry [baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3]

   nutrient utilization according to respiratory exchange ratio (0.66 - 1.0)

2. ketosis [baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3]

   plasma ß-hydroxybutyrate (mM)

3. eosinophilic asthma characterization [baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3]

   absolute blood eosinophils (count)

4. immunoglobulin asthma characterization [baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3]

   blood immunoglobulin E (IgE)

5. systemic inflammation [baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3]

   blood cytokines (IL17, TNFα, IL1ß)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: 18-65 years

• BMI: 18.5 - 29.99 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
• National Heart, Lung, and Blood Institute (NHLBI)

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: NCT06151405
• Other Study ID Numbers: PBRC 2022-001 B; 1K01HL169491-01
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jacob T. Mey, PhD RD, Principal Investigator, Pennington Biomedical Research Center: ketone; diet; metabolism
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Nov 30, 2023