Asthma Inflammation Research

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT01536522
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Nutritional approach for asthma — DIETARY_SUPPLEMENT
    participants will be provided a medium chain triglyceride supplement or placebo
  • Low Caloric Shake — DIETARY_SUPPLEMENT
    participants will be provided a low caloric dietary shake
  • whole lung allergen challenge — BIOLOGICAL
    inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation

Study Details

The overall goal of the Asthma Inflammation Research \[AIR\] Translational Program is to create an integrated multidisciplinary team for the focused purpose of development of diagnostic and prognostic tests informative for airway inflammation, and for the design of innovative, targeted biologic therapeutics. The overarching aims of the AIR program are to conceptualize, develop, and test the next-generation therapeutics, and novel asthma diagnostic and prognostic tools that will allow us to improve the standard of asthma care.

Key Dates

Start date
Jan 31, 2011
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Active Comparator: Nutritional Approach for Asthma
    individuals will be provide a pre measured dose of medium chain triglyceride to consume along with their meals. They will be instructed to add the MCT to their meal 3 times per day
  • Placebo Comparator: Standard American Diet
    patients will consume their usual diet with a pre measured dose of canola oil in place of the medium chain triglyceride as a control group. They will be instructed to add the placebo dose to their meal 3 times a day
  • Active Comparator: Alternate Day Diet
    patients will consume a regular "Standard American Diet" for 4 weeks and then provided a regulated dosed quantity of low caloric value "shakes". they will consume this on alternating days
  • Active Comparator: Whole Lung Allergen Challenge
    patients with or without asthma will be given controlled doses of specified allergens

Primary Outcome Measure

Maintaining a tolerance to Medium Chain Triglyceride (MCT) additive for Asthmatics [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-

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