MoralityNCT03281512
Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight
An observational study of Morality and Diabetes, run by Zhejiang University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morality, Diabetes, Hypertension
- How many people
- 14,383 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1989to 31 Dec 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.
Who may be able to join
- Adults aged ≥20 with complete data on diet and follow-up time
Who cannot join
- Cardiovascular diseases
- Diabetes (for analyses of diabetes)
- Body mass index ≥ 24 kg/㎡ (for analyses of overweight)
- Hypertension (for analyses of hypertension)
About this study
Official title: 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.
Read the 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.
- Conditions
- Morality, Diabetes, Hypertension, Overweight
- Keywords
- Saturated fatty acids, CHNS
- Medical subject headings
- Diabetes Mellitus, Hypertension, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Incidence of all-cause death, on basis of household members' report
Measured: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years
Diabetes
Incidence of diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
Measured: From entry into the study (baseline: 1997-2009) until 2011
Secondary outcomes (3)
Saturated fatty acids intake
Cumulative average intake of saturated fatty acids on basis of 3 consecutive 24-h dietary recalls
Measured: From entry into the study (baseline: 1997-2009) until 2011
Hypertension
Incidence of hypertension, on basis of self-reported physician diagnosis, systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
Measured: From entry into the study (baseline: 1997-2009) until 2011
Overweight
Incidence of overweight, on basis of body mass index (BMI), BMI ≥ 24 kg/㎡
Measured: From entry into the study (baseline: 1997-2009) until 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 1989
- Primary completion31 Dec 2011
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoralityStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 14,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Responsible party
- Principal investigator, Jingjing Jiao, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281512
- Sponsor's protocol ID
- Cohort_SFA
- Status last verified
- Mar 2024
- First submitted
- 11 Sep 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhuang P, Cheng L, Wang J, Zhang Y, Jiao J. Saturated Fatty Acid Intake Is Associated with Total Mortality in a Nationwide Cohort Study. J Nutr. 2019 Jan 1;149(1):68-77. doi: 10.1093/jn/nxy237.
PubMed 30608597
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight in the China Health and Nutrition Survey (CHNS)
- ClinicalTrials.gov ID
- NCT03281512
- Acronym / sponsor ID
- Cohort_SFA
- Conditions
- Morality, Diabetes, Hypertension, Overweight
- Keywords
- Saturated fatty acids, CHNS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,383 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Study start
- 1 Jan 1989 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 13 Sep 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Adults aged ≥20 with complete data on diet and follow-up time
Key exclusion criteria (4 listed)
- Cardiovascular diseases
- Diabetes (for analyses of diabetes)
- Body mass index ≥ 24 kg/㎡ (for analyses of overweight)
- Hypertension (for analyses of hypertension)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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%
3 secondary outcomes
Saturated fatty acids intake
Time frame: From entry into the study (baseline: 1997-2009) until 2011
Hypertension
Time frame: From entry into the study (baseline: 1997-2009) until 2011
Overweight
Time frame: From entry into the study (baseline: 1997-2009) until 2011
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 15 Mar 2024.
- Derived from this study: PubMed 30608597Zhuang P, Cheng L, Wang J, Zhang Y, Jiao J. Saturated Fatty Acid Intake Is Associated with Total Mortality in a Nationwide Cohort Study. J Nutr. 2019 Jan 1;149(1):68-77. doi: 10.1093/jn/nxy237.
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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 Morality and Diabetes, 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 4 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?
Mortality (time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years). The study lists 2 primary outcomes in all. 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 NCT03281512, which also lists 1 linked publication.
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.