Nutrition for Asthmatics

NCT06151405 | Recruiting DMC

• 2 other identifiers: PBRC 2022-001 B1K01HL169491-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

ketone; diet; metabolism

Outcome Measures

Primary Outcomes (8)

• Asthma Control

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

  Baseline

• Asthma Control

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

  After 7 days on Diet#1

• Asthma Control

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

  After 7 days on Diet#2

• Asthma Control

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

  After 7 days on Diet#3

• Lung Function

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

  Baseline

• Lung Function

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

  After 7 days on Diet#1

• Lung Function

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

  After 7 days on Diet#2

• Lung Function

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

  After 7 days on Diet#3

Secondary Outcomes (12)

• Systemic inflammation

  Baseline

• Systemic inflammation

  After 7 days on Diet#1

• Systemic inflammation

  After 7 days on Diet#2

• Systemic inflammation

  After 7 days on Diet#3

• FENO

  Baseline

Other Outcomes (5)

• indirect calorimetry

  baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

• ketosis

  baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

• eosinophilic asthma characterization

  baseline, after 7 days on Diet#1, after 7 days on Diet#2, after 7 days on Diet#3

Study Arms (3)

Dietary Guidelines for Americans

EXPERIMENTAL

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

Other: DGA Diet

Medium Chain Triglyceride Supplemented DGA

EXPERIMENTAL

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

Other: MCT Diet

Ketogenic Diet

EXPERIMENTAL

7 days of a ketogenic diet (KETO).

Other: KETO Diet

Interventions

DGA Diet 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.

Dietary Guidelines for Americans

MCT Diet OTHER

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

Medium Chain Triglyceride Supplemented DGA

KETO Diet OTHER

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Ketosis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jacob T Mey, PhD, RD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob T Mey, PhD, RD

CONTACT

225-763-2644; jacob.mey@pbrc.edu

John P Kirwan, PhD

CONTACT

225-763-2644; john.kirwan@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: July 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)