AsthmaNCT03189251
HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS
An observational study of Asthma, run by Luanne R DeChristopher.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Dietary intakes
- Type of treatment
- Pill or oral medicine
- How many people
- 2,657 participants
- Where
- No sites listed yet
- Study dates
- Jun 1971to Jun 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants in the Framingham Heart Study (Offspring) cohort
Who may be able to join
- 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.
Who cannot join
- Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)
About this study
Official title: Moderate Intake of High Fructose Corn Syrup Sweetened Soft Drinks, Fruit Drinks and Apple Juice Increases Asthma Risk - the Framingham Offspring Cohort
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.
- Conditions
- Asthma
- Being tested
- Dietary intakes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Exams 3 - 7, 17 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startJun 1971
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luanne R DeChristopher
- Collaborators
- Jaime Uribarri, M.D., Katherine L. Tucker, Ph.D.
- Responsible party
- Sponsor-investigator, Luanne R DeChristopher, DeChristopher, Luanne R.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189251
- Sponsor's protocol ID
- EFF, HFCS, asthma-the FHS-OS
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Intake of High Fructose Corn Syrup Sweetened Soft Drinks, Fruit Drinks and Apple Juice Increases Asthma Risk - the Framingham Offspring Cohort
- ClinicalTrials.gov ID
- NCT03189251
- Acronym / sponsor ID
- EFF, HFCS, asthma-the FHS-OS
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,657 participants (actual)
- Lead sponsor
- Luanne R DeChristopher
- Collaborators
- Jaime Uribarri, M.D., Katherine L. Tucker, Ph.D.
- Study start
- Jun 1971 (actual)
- Primary completion
- Jun 2001 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in the Framingham Heart Study (Offspring) cohort
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intakesAnalysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) | Other | – |
Primary outcome
Asthma
Time frame: Exams 3 - 7, 17 years of follow-up
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Luanne R DeChristopher.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma (time frame: Exams 3 - 7, 17 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.