NCT02525354

Brief Summary

Epidemiological studies have shown obesity to be a risk factor of asthma. Research evidence of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. The purpose of the present study was to test the hypothesis that the relationship between obesity and atopic-related respiratory disease in premenopausal women is mediated by a dietary imbalance of omega 6 and 3 polyunsaturated fatty acids.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2001

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

October 1, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
Last Updated

August 17, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

June 15, 2015

Last Update Submit

August 13, 2015

Conditions

Keywords

arachidonic aciadiposityatopy

Outcome Measures

Primary Outcomes (1)

  • Predictors of serum concentration of specific and total IgE antibodies in obesity

    Measures of insulin sensitivity, plasma concentrations of leptin, adiponectin, , estrogen, IL-18,and dietary arachidonic, eicosapentanoic, docosahexanoic fatty acids were entered as independent variables; and serum concentration of specific and total IgE antibodies as dependent variable, in a forward stepwise multivariate linear regression analysis to identify which factor(s) had the greatest influence on serum concentrations of IgE antibodies in obesity.

    one day

Secondary Outcomes (2)

  • Relationship between dietary levels of arachidonic, eicosapentanoic, docosahexanoic fatty acids and plasma concentration of leptin in obesity

    one day

  • Correlation between dietary arachidonic, eicosapentanoic,and docoshexanoic fatty acids and plasma concentration of adiponectin in obesity

    one day

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female subjects were recruited from the University and surrounding local communities, using posted flyers, website announcements, personal announcements in classes, referrals from local physicians, and word of mouth. Prospective subjects were interviewed initially by telephone.

You may qualify if:

  • For asthmatics, only individuals that were willing and capable of not using asthma medications for two days prior to laboratory testing.

You may not qualify if:

  • An individual was excluded from the study if she had a history of high blood pressure, diabetes, heart disease, cigarette smoking, or eating disorders.
  • Women that were pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (44)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Conditions

HypersensitivityObesity

Condition Hierarchy (Ancestors)

Immune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 15, 2015

First Posted

August 17, 2015

Study Start

October 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

August 17, 2015

Record last verified: 2015-07