Plasma, Urine and Tear Omics Changes in Different Diets

Study Overview
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Brief Summary
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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.

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

Conditions
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Diet, Healthy

Intervention / Treatment
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* Other: diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%; 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; 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; Those who can communicate well with the investigator and understand and comply with the requirements of this experiment. Exclusion Criteria: Active eating disorder; previous history of bariatric surgery; Diabetes; Those who have had serious gastrointestinal diseases in the past; Diarrhea, nausea and vomiting in the past 2 weeks; 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 Those who have drug abuse or alcohol addiction; Patients with severe mental or neurological diseases; Pregnant women, breastfeeding women, or women who plan to give birth within the past month; Those who have special dietary requirements or have food allergies such as soy products and dairy products; Participating in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healty subject<br> | Other: diet<br>* have OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomics and metabolomics changes after diet intervention | Changes of plasma, urine, tear proteomics and metabolomics after diet intervention | 5 weeks |