Recruiting

Nutrition

Sponsor:

Pennington Biomedical Research Center

Code:

NCT06151405

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

DGA Diet

MCT Diet

KETO Diet

Study Details

Brief summary:

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

Conditions

Asthma

Study ID

NCT06151405

Start date

Jul 17, 2024

Status verified date

Sep, 2024

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dietary Guidelines for Americans

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

experimental: Medium Chain Triglyceride Supplemented DGA

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

experimental: Ketogenic Diet

7 days of a ketogenic diet (KETO).

Interventions

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.

MCT Diet

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

KETO Diet

A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Primary outcome measure

  • Asthma Control [ Time Frame: Baseline ]
  • Asthma Control [ Time Frame: After 7 days on Diet#1 ]
  • Asthma Control [ Time Frame: After 7 days on Diet#2 ]
  • Asthma Control [ Time Frame: After 7 days on Diet#3 ]
  • Lung Function [ Time Frame: Baseline ]
  • Lung Function [ Time Frame: After 7 days on Diet#1 ]
  • Lung Function [ Time Frame: After 7 days on Diet#2 ]
  • Lung Function [ Time Frame: After 7 days on Diet#3 ]

Central Contacts and Locations

Central contacts

Jacob T Mey, PhD, RD

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

John P Kirwan, PhD

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

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Executive Director

225-763-2513

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • ketone
  • diet
  • metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2024-09-19.