NCT03189251

Brief Summary

Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,657

participants targeted

Target at P75+ for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1971

Completed
30 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
16 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

30 years

First QC Date

June 14, 2017

Last Update Submit

June 14, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Asthma

    Incident asthma defined as self-reported asthma (at each exam), including wheezing or asthma (have you had asthma/ wheeze since the last exam of short duration, long duration or with respiratory infections)

    Exams 3 - 7, 17 years of follow-up

Interventions

Dietary intakesOTHER

Analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice)

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants in the Framingham Heart Study (Offspring) cohort

You may qualify if:

  • Participants in the FHS Offspring who answered questions in the FFQ about soft drinks, fruit drinks and fruit juice consumption; Participants with non-missing data for the exposures and potentially confounding variables of interest.

You may not qualify if:

  • Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Eating

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Independent Researcher

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

June 1, 1971

Primary Completion

June 1, 2001

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share