Chronic DiseasesPNFSNCT05247632
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study
An observational study of Chronic Diseases, run by Zhejiang University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Diseases
- How many people
- 2,290 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2018to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- Adult, Older adult
Study population: Subjects are eligible residents from 10 government-administered units including 7 urban towns and 3 rural villages of Jinhua, China.
Who may be able to join
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Who cannot join
- had the major illness that had made personal life disabled
Trial locations and contacts
2 sites in 1 country.
China2 sites
Lanxi Hospital of Traditional Chinese Medicine
Jinhua
Lanxi Red Cross Hospital
Lanxi, Zhejiang, 321100
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Diseases
- Keywords
- Food safety, Food nutrition, Food contaminant, Mult-omics, Chronic diseases
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with metabolic syndrome
metabolic syndrome
Measured: From entry into the study baseline:2018 until 2023
Numbers of participants with obesity
Obesity
Measured: From entry into the study baseline:2018 until 2023
Numbers of participants with diabetes
Diabetes
Measured: From entry into the study baseline:2018 until 2023
Secondary outcomes (2)
Numbers of participants died
All-cause and cause-specific mortality
Measured: From entry into the study baseline:2018 until 2023
Numbers of participants with cardiovascular diseases
Cardiovascular diseases
Measured: From entry into the study baseline:2018 until 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 May 2018
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseasesStudies 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
- 2,290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Lanxi Red Cross Hospital, Lanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Yu Zhang, Zhejiang University
- Investigators
- Weifang Zheng, Study director, Lanxi Red Cross HospitalJingjing Jiao, Principal investigator, Zhejiang UniversityYu Zhang, Principal investigator, Zhejiang UniversityPan Zhuang, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247632
- Sponsor's protocol ID
- Cohort-PNFS
- Acronym
- PNFS
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease (PNFS) Study
- ClinicalTrials.gov ID
- NCT05247632
- Acronym / sponsor ID
- PNFS / Cohort-PNFS
- Conditions
- Chronic Diseases
- Keywords
- Food safety, Food nutrition, Food contaminant, Mult-omics, Chronic diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,290 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Lanxi Red Cross Hospital, Lanxi Hospital of Traditional Chinese Medicine
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Feb 2022 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects are eligible residents from 10 government-administered units including 7 urban towns and 3 rural villages of Jinhua, China.
Key inclusion criteria (2 listed)
- Subject aged ≥45 and ≤74 years old
- Subject has complete data on diet and follow-up time
Key exclusion criteria (1 listed)
- had the major illness that had made personal life disabled
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
Numbers of participants with metabolic syndrome
Time frame: From entry into the study baseline:2018 until 2023
metabolic syndrome
Numbers of participants with obesity
Time frame: From entry into the study baseline:2018 until 2023
Obesity
Numbers of participants with diabetes
Time frame: From entry into the study baseline:2018 until 2023
Diabetes
2 secondary outcomes
Numbers of participants died
Time frame: From entry into the study baseline:2018 until 2023
Numbers of participants with cardiovascular diseases
Time frame: From entry into the study baseline:2018 until 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
Weifang Zheng study director
Lanxi Red Cross Hospital
Jingjing Jiao principal investigator
Zhejiang University
Yu Zhang principal investigator
Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diseases, run by Zhejiang University at 2 sites in China.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Numbers of participants with metabolic syndrome (time frame: From entry into the study baseline:2018 until 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2024.