Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight

March 12, 2024 updated by: Jingjing Jiao, Zhejiang University

Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight in the China Health and Nutrition Survey (CHNS)

The role of saturated fatty acids (SFAs) intake in the development of total death, cardiovascular diseases, diabetes, hypertension and overweight are in great controversy but evidence from large population in China is scant.The investigators aim to use the data from the China Health and Nutrition Survey to assess the long-term association of SFAs intake with total mortality, diabetes, hypertension and overweight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The role of saturated fatty acids (SFAs) intake in the development of total death, diabetes, hypertension and overweight are in great controversy but evidence from large population in China is lacking.The investigators aim to utilize the data from the China Health and Nutrition Survey. The investigators will calculate the cumulative average intake of SFAs based on 3 consecutive 24-h dietary recalls in each round.Sex-specific Cox regression models will be used to estimate the relative risk.Results from our work will be used to provide epidemiological evidence for improving recommendation on SFAs intake for Chinese in dietary guidelines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiovascular diseases
  • Diabetes (for analyses of diabetes)
  • Body mass index ≥ 24 kg/㎡ (for analyses of overweight)
  • Hypertension (for analyses of hypertension)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years
Incidence of all-cause death, on basis of household members' report
From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years
Diabetes
Time Frame: From entry into the study (baseline: 1997-2009) until 2011
Incidence of diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
From entry into the study (baseline: 1997-2009) until 2011

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Saturated fatty acids intake
Time Frame: From entry into the study (baseline: 1997-2009) until 2011
Cumulative average intake of saturated fatty acids on basis of 3 consecutive 24-h dietary recalls
From entry into the study (baseline: 1997-2009) until 2011
Hypertension
Time Frame: From entry into the study (baseline: 1997-2009) until 2011
Incidence of hypertension, on basis of self-reported physician diagnosis, systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
From entry into the study (baseline: 1997-2009) until 2011
Overweight
Time Frame: From entry into the study (baseline: 1997-2009) until 2011
Incidence of overweight, on basis of body mass index (BMI), BMI ≥ 24 kg/㎡
From entry into the study (baseline: 1997-2009) until 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Health and Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1989

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cohort_SFA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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