Diet, HealthyNCT04984642
Plasma, Urine and Tear Omics Changes in Different Diets
A study testing diet in people with Diet, Healthy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The study plans to start in July 2021, and it is expected that 20 healthy people (aged 18-70 years old, BMI 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. Participants will be enrolled in the group through the screening and plan to take regular diet, OGTT, high-fat diet, low-calorie diet and… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals aged 20-70 years, with a body mass index (BMI) of 18.5-40 kg/m².
- No known chronic medical conditions.
- Willingness to comply with study requirements and adhere to the intervention protocol.
Who cannot join
- Presence of significant medical conditions or chronic diseases.
- Diagnosis of diabetes mellitus or prediabetes.
- Triglyceride level ≥4 mmol/L.
- Blood pressure ≥160/100 mmHg or presence of malignant hypertension.
- History of an eating disorder.
- Previous bariatric surgery.
Show all 10Show fewer
- Severe gastrointestinal diseases.
- History of diarrhea within the past two weeks.
- Special dietary requirements or known food allergies.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Plasma, Urine and Tear Omics Changes Based on Protein and Metabonomics Technology in Different Diets and Screening of Healthy Diet Markers
The study plans to start in July 2021, and it is expected that 20 healthy people (aged 18-70 years old, BMI 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. Participants will be enrolled in the group through the screening and plan to take regular diet, OGTT, high-fat diet, low-calorie diet and ketogenic diet within 5 weeks. The proteomics and metabolomics indicators of tear, plasma, and urine specimens will be measured at 5 time points at baseline, 30 minutes, 1 hour, 2 hours, and 3 hours for each diet. The correlation of proteomics and metabolomics indicators with classic laboratory parameters (BMI, HDL, LDL, cholesterol, triglyceride levels, and insulin resistance (HOMA-IR)) will be analyzed.
- Conditions
- Diet, Healthy
- Being tested
- diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
have OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn
| Study group | Role | What they receive |
|---|---|---|
| healty subject | Experimental | Not described Receives: Other: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics and metabolomics changes after diet intervention
Changes of plasma, urine, tear proteomics and metabolomics after diet intervention
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984642
- Sponsor's protocol ID
- 2020-865
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma, Urine and Tear Omics Changes Based on Protein and Metabonomics Technology in Different Diets and Screening of Healthy Diet Markers
- ClinicalTrials.gov ID
- NCT04984642
- Acronym / sponsor ID
- 2020-865
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Jul 2021 (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 study plans to start in July 2021, and it is expected that 20 healthy people (aged 18-70 years old, BMI 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. Participants will be enrolled in the group through the screening and plan to take regular diet, OGTT, high-fat diet, low-calorie diet and ketogenic diet within 5 weeks. The proteomics and metabolomics indicators of tear, plasma, and urine specimens will be measured at 5 time points at baseline, 30 minutes, 1 hour, 2 hours, and 3 hours for each diet. The correlation of proteomics and metabolomics indicators with classic laboratory parameters (BMI, HDL, LDL, cholesterol, triglyceride levels, and insulin resistance (HOMA-IR)) will be analyzed.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healty subject | Experimental | Other: diet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals aged 20-70 years, with a body mass index (BMI) of 18.5-40 kg/m².
- No known chronic medical conditions.
- Willingness to comply with study requirements and adhere to the intervention protocol.
Key exclusion criteria (10 listed)
- Presence of significant medical conditions or chronic diseases.
- Diagnosis of diabetes mellitus or prediabetes.
- Triglyceride level ≥4 mmol/L.
- Blood pressure ≥160/100 mmHg or presence of malignant hypertension.
- History of an eating disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diethave OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn | Other | healty subject |
Primary outcome
Proteomics and metabolomics changes after diet intervention
Time frame: 5 weeks
Changes of plasma, urine, tear proteomics and metabolomics after diet intervention
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet in people with Diet, Healthy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 3 inclusion and 10 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Proteomics and metabolomics changes after diet intervention (time frame: 5 weeks). 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 24 Feb 2025.