Plasma, Urine and Tear Omics Changes in Different Diets | NCT04984642

Studies
Plasma, Urine and Tear Omics Changes in Different Diets

NCT04984642

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Diet, Healthy

Interventions

diet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Jul 21, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healty subject	Experimental		Other: diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diet	Other	have OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn	healty subject

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided