Plasma, Urine and Tear Omics Changes in Different Diets

Diet, Healthy Clinical Trial

Official title:

Plasma, Urine and Tear Omics Changes Based on Protein and Metabonomics Technology in Different Diets and Screening of Healthy Diet Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984642
• Other study ID #: 2020-865
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pengfei Shan, MD
• Phone: +86 13958039665
• Email: pengfeishan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18-70 years old, BMI 18.5-40 kg/m2, fasting blood glucose within 7mmol/L; weight fluctuation within 3 months does not exceed 5%;

2. The volunteers had no history of serious cardiovascular, liver, kidney, respiratory, blood, endocrine, immune, neuropsychiatric and other diseases within 1 year, and were in good general health at the time of enrollment;

3. Willing to accept a prescribed diet test every 3-9 days for 4 consecutive times, and are willing to keep samples of blood, urine, feces, and tears;

4. Those who can communicate well with the investigator and understand and comply with the requirements of this experiment.

Exclusion Criteria:

1. Active eating disorder; previous history of bariatric surgery;

2. Diabetes;

3. Those who have had serious gastrointestinal diseases in the past;

4. Diarrhea, nausea and vomiting in the past 2 weeks;

5. Patients with significant dysfunction of heart, liver, kidney, and systemic organs (NYHA heart function grade = II; ALT and/or AST increased to more than 5 times the upper limit of normal; GFR <30 ml/min), or malignant tumors Medical history

6. Those who have drug abuse or alcohol addiction;

7. Patients with severe mental or neurological diseases;

8. Pregnant women, breastfeeding women, or women who plan to give birth within the past month;

9. Those who have special dietary requirements or have food allergies such as soy products and dairy products;

10. Participating in other clinical trials.

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Other:
• diet
have OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomics and metabolomics changes after diet intervention	Changes of plasma, urine, tear proteomics and metabolomics after diet intervention	5 weeks