Plasma, Urine and Tear Omics Changes in Different Diets

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diet, Healthy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

Other

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

Primary outcomes

Proteomics and metabolomics changes after diet intervention

Time frame: 5 weeks

Changes of plasma, urine, tear proteomics and metabolomics after diet intervention

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 30, 2021
Registry last updated: Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed