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Polyunsaturated Fatty AcidsNCT03155659

Fish, Polyunsaturated Fatty Acids Intake and Mortality

An observational study of Polyunsaturated Fatty Acids and Mortality, run by Zhejiang University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and National Health and Nutrition Examination Survey (NHANES) to investigate the associations of fish and polyunsaturated fatty acids (PUFA) intake with… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Polyunsaturated Fatty Acids, Mortality
How many people
50,145 participants
Where
No sites listed yet
Study dates
Jan 1989to Jul 2012
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities, which take up about half of Chinese population. NHANES is also a nationally-representative study of nutrition and health for individuals residing in the U.S. Our study included participants in CHNS and NHANES who met the eligibility criteria.

Who may be able to join

  • Adults aged ≥20 with complete data on diet and follow-up time

Who cannot join

  • Missing information for mortality
  • Cardiovascular disease
  • Cancer

About this study

Official title: Fish, Polyunsaturated Fatty Acids Intake and Mortality: Analysis of CHNS and NHANES

Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and National Health and Nutrition Examination Survey (NHANES) to investigate the associations of fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US populations. The study findings will be informative for addressing the role of fish and specific PUFA in human health and improve basis for dietary recommendations.

Read the detailed description

Data from the China Health and Nutrition Survey (CHNS, from 1989 to 2011) and National Health and Nutrition Examination Survey (NHANES), including NHANES III conducted in 1988-1994 and continuous NHANES 1999-2010 were used to investigate the associations of fish and polyunsaturated fatty acids intake with mortality.The following variables were used:

  1. Demographics: age, sex, race/ethnicity, residence
  2. Socioeconomic variables: education, marital status,
  3. Dietary variables: Intakes of fish, polyunsaturated fatty acids, total energy, vegetables, fruits, red meat and saturated fat
  4. Clinical assessments: hypertension, diabetes, cancer, cardiovascular disease (CVD), family history of CVD
Keywords
Fish, Polyunsaturated fatty acids, Mortality, CHNS, NHANES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Mortality

    Total Mortality from All Causes

    Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years

Secondary outcomes (1)

  1. Cause-specific mortality

    Cause-specific mortality from diseases

    Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study startJan 1989
  3. Primary completionDec 2011
  4. Study completionJul 2012

Resources

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
Prospective
Enrolment
50,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155659
Sponsor's protocol ID
Cohort_PUFA
Status last verified
Mar 2024
First submitted
13 May 2017
Last updated
15 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao LG, Sun JW, Yang Y, Ma X, Wang YY, Xiang YB. Fish consumption and all-cause mortality: a meta-analysis of cohort studies. Eur J Clin Nutr. 2016 Feb;70(2):155-61. doi: 10.1038/ejcn.2015.72. Epub 2015 May 13.

    PubMed 25969396

  • Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis. JAMA. 2012 Sep 12;308(10):1024-33. doi: 10.1001/2012.jama.11374.

    PubMed 22968891

  • Zhuang P, Wang W, Wang J, Zhang Y, Jiao J. Polyunsaturated fatty acids intake, omega-6/omega-3 ratio and mortality: Findings from two independent nationwide cohorts. Clin Nutr. 2019 Apr;38(2):848-855. doi: 10.1016/j.clnu.2018.02.019. Epub 2018 Mar 3.

    PubMed 29551407

Questions about this trial

What is this clinical trial studying?

An observational study of Polyunsaturated Fatty Acids and Mortality, run by Zhejiang University.

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 3 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 15 Mar 2024. 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?

Total Mortality (time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155659, which also lists 3 linked publications.

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 15 Mar 2024.

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