Fatty Acids in Airway Smooth Muscle of Asthmatics

NCT02809235 | Withdrawn

• 1 other identifier: 2016P000273
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this proof of concept study, the investigators aim to determine if supplementation with coconut oil causes an increase in cholecystokinin and cholecystokinin receptor expression in the airway smooth muscle of lean asthmatics, and whether these changes correlate with changes in airway stiffness (estimated by bronchodilator reversibility, airway reactivity, and airway resistance) or symptom control. The investigators propose a 5 week, single center trial in 20 lean patients with mild asthma (not taking inhaled corticosteroids) aged 18 and older. Subjects will supplement their usual diets with 3 tablespoons of coconut oil, a commercially available oil with high dodecanoic acid content, for 3 weeks. To quantify changes in airway smooth muscle cholecystokinin and cholecystokinin-receptor expression, each subject will undergo bronchoscopy with endobronchial biopsies before and after coconut oil ingestion. For the secondary analysis, subjects will also complete spirometry with bronchodilator testing, methacholine challenge, body plethysmography, and an Asthma Control Questionnaire (ACQ) before and after the dietary intervention. This information will be used to compare the changes in airway smooth muscle cholecystokinin and cholecystokinin receptor expression to changes in bronchodilator reversibility, airway reactivity, airway resistance, and symptom control. In the exploratory aims, the investigators will correlate the changes in airway smooth muscle cholecystokinin and cholecystokinin receptor expression with changes in FEV1 and peak flow measurements. The investigators therefore hope to elucidate information about the mechanistic role of cholecystokinin in airway smooth muscle stiffness and contraction.

Conditions

Asthma

Keywords

asthma; smooth muscle; lauric acid; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Change in Airway Smooth Muscle (ASM) Cholecystokinin (CCK) and Cholecystokinin Receptor (CCK-AR) expression with coconut oil supplementation

  3 weeks

Secondary Outcomes (4)

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in bronchodilator reversibility.

  3 weeks

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in bronchial hyperresponsiveness (PC20).

  3 weeks

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in airway resistance

  3 weeks

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in Asthma Control Questionnaire (ACQ) score.

  3 weeks

Other Outcomes (2)

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in Forced Expiratory Volume in 1 second (FEV1).

  3 weeks

• Change in ASM CCK and CCK-AR expression with coconut oil supplementation, versus change in peak flow.

  3 weeks

Study Arms (1)

coconut oil

EXPERIMENTAL

Subjects will be instructed to supplement their diet with 3 tablespoons of coconut oil daily for three weeks.

Dietary Supplement: coconut oil

Interventions

coconut oil DIETARY_SUPPLEMENT

3 tablespoons per day of supplemental coconut oil

coconut oil

Eligibility Criteria

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

You may qualify if:

• Male and female participants, age 18 years and older at enrollment
• Never smokers or \<10 pack year smoking history
• Body mass index (BMI) \<25
• Clinical history consistent with asthma for \>1 year
• No use of an inhaled corticosteroid in the prior 3mo
• Ability to perform reproducible spirometry according to ATS criteria
• Baseline Forced expiratory volume in 1 second (FEV1) ≥ 60% predicted
• Presence of bronchodilator reversibility, as defined by a minimum of 12% and ≥ 200 ml improvement after 4 puffs of albuterol, each 90 μg
• Ability to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board.

You may not qualify if:

• Supplementation with fatty acids within the last 3 months
• BMI ≥25
• Pregnant or nursing
• History of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or \>10 pack-years total
• Use of inhaled corticosteroid in the prior 3 mo
• Lack of bronchodilator response to 4 puffs of albuterol
• Medical contraindication to bronchoscopy/biopsy, i.e inability to stop aspirin, anticoagulant, or antiplatelet at any point during the study; coagulopathy; inability to lay flat; asthma exacerbation requiring corticosteroids in the preceding 4 weeks; history of adverse reaction or allergy to sedatives; history of difficult airway, or past difficulty with intubation
• Major medical problems prohibiting study participation, i.e presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma
• Evidence that the participant may be non-adherent to medication regimen, or may move from the performance site area before trial completion

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Elliot Israel, MD

  Asthma Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elliot Israel, MD

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 23, 2024

Record last verified: 2023-11

Locations

US (1)