- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281512
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
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
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
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
Collaborators
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.
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)
January 1, 1989
Primary Completion (Actual)
December 31, 2011
Study Completion (Actual)
December 31, 2012
Study Registration Dates
First Submitted
September 11, 2017
First Submitted That Met QC Criteria
September 11, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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