Plasma, Urine and Tear Omics Changes in Different Diets
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Severe gastrointestinal diseases.
- History of diarrhea within the past two weeks.
- Special dietary requirements or known food allergies.
- Pregnancy or breastfeeding.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Pengfei Shan, MD
Data sourced from clinicaltrials.gov
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