Plasma, Urine and Tear Omics Changes in Different Diets

Not Applicable

Completed

• Conditions: Diet, Healthy

• Registration Number: NCT04984642
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Primary Completion: 2022-01-01
• Study Completion: 2022-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Healthy individuals aged 20-70 years, with a body mass index (BMI) of 18.5-40 kg/m².
2. No known chronic medical conditions.
3. Willingness to comply with study requirements and adhere to the intervention protocol.

Exclusion Criteria

1. Presence of significant medical conditions or chronic diseases.
2. Diagnosis of diabetes mellitus or prediabetes.
3. Triglyceride level ≥4 mmol/L.
4. Blood pressure ≥160/100 mmHg or presence of malignant hypertension.
5. History of an eating disorder.
6. Previous bariatric surgery.
7. Severe gastrointestinal diseases.
8. History of diarrhea within the past two weeks.
9. Special dietary requirements or known food allergies.
10. Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proteomics and metabolomics changes after diet intervention	5 weeks	Changes of plasma, urine, tear proteomics and metabolomics after diet intervention

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China