- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05247632
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study (PNFS)
January 7, 2024 updated by: Yu Zhang, Zhejiang University
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease (PNFS) Study
The associations between food nutrition and safety factors with the risk of chronic diseases are still unclear.
This study is conducted in Jinhua, a city with a high prevalence of chronic diseases in China, to assess relations between food nutrition and safety factors and chronic diseases.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Investigations of associations of food nutrition and safety factors with the risk of chronic diseases are limited and studies in China are still lacking.
The investigators aim to collect basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors, and so on, to assess the association of food nutrition and safety factors including various food items, dietary fatty acids, and internal biomarkers of food contaminants such as acrylamide and 3-MCPD with various chronic diseases in a Chinese middle-aged and elderly population.
We will use multi-omics technology to investigate the causal mechanisms.
Results from this study will be valuable for chronic diseases prevention in China.
Study Type
Observational
Enrollment (Estimated)
2290
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jinhua, China
- Lanxi Hospital of Traditional Chinese Medicine
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Zhejiang
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Lanxi, Zhejiang, China, 321100
- Lanxi Red Cross Hospital
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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
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Subjects are eligible residents from 10 government-administered units including 7 urban towns and 3 rural villages of Jinhua, China.
Description
Inclusion Criteria:
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Exclusion Criteria:
had the major illness that had made personal life disabled
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 |
---|---|---|
Numbers of participants with metabolic syndrome
Time Frame: From entry into the study baseline:2018 until 2023
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metabolic syndrome
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From entry into the study baseline:2018 until 2023
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Numbers of participants with obesity
Time Frame: From entry into the study baseline:2018 until 2023
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Obesity
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From entry into the study baseline:2018 until 2023
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Numbers of participants with diabetes
Time Frame: From entry into the study baseline:2018 until 2023
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Diabetes
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From entry into the study baseline:2018 until 2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numbers of participants died
Time Frame: From entry into the study baseline:2018 until 2023
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All-cause and cause-specific mortality
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From entry into the study baseline:2018 until 2023
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Numbers of participants with cardiovascular diseases
Time Frame: From entry into the study baseline:2018 until 2023
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Cardiovascular diseases
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From entry into the study baseline:2018 until 2023
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numbers of participants with fatty liver disease
Time Frame: From entry into the study baseline:2018 until 2023
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Fatty liver disease
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From entry into the study baseline:2018 until 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jingjing Jiao, Zhejiang University
- Principal Investigator: Pan Zhuang, Zhejiang University
- Study Director: Weifang Zheng, Lanxi Red Cross Hospital
- Principal Investigator: Yu Zhang, Zhejiang University
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)
May 1, 2018
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
February 3, 2022
First Submitted That Met QC Criteria
February 9, 2022
First Posted (Actual)
February 21, 2022
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 7, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cohort-PNFS
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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