NCT06636396

Brief Summary

The purpose of this study is to assess the use of a practical tool to objectively measure the fruit and vegetable intake in people with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

November 12, 2021

Last Update Submit

October 9, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • FEV1

    forced expiratory volume in one second

    measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.

  • ACT

    Asthma control test results in a score of 5-25, with a lower score indicating better asthma control.

    measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.

  • Skin Carotenoid Level

    Skin carotenoid level, measured with a non-invasive tool and is an indicator of fruit and vegetable intake. Skin carotenoid levels are shown as a score of 0-800, with a higher score representing a higher level of carotenoids.

    measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.

  • Diet Intake

    Nutrascreen diet questionnaire to assess nutritional intake. Specifically, quantity of fruits and vegetable intake will be assessed.

    measured at a single time point when recruited in the study (cross sectional). Study outcomes will be reported upon study completion, approximately 1 year from study onset.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All people with asthma who are at least 18 years of age.

You may qualify if:

  • Pulmonary patients 18 years of age and older
  • Confirmed diagnosis of asthma by a physician and confirmed by a pulmonary physician
  • English speaking
  • Access to the internet

You may not qualify if:

  • Acute upper or lower respiratory infection
  • Systemic corticosteroids
  • Recent or current confirmed diagnosis of Covid-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dave Burnett, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

October 10, 2024

Study Start

November 8, 2021

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

October 10, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations