Plasma, Urine and Tear Omics Changes in Different Diets

NCT ID: NCT04984642

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Diet, Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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healty subject

Group Type EXPERIMENTAL

diet

Intervention Type OTHER

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

Interventions

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diet

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2020-865

Identifier Type: -

Identifier Source: org_study_id

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