NCT04984642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

July 8, 2021

Last Update Submit

February 20, 2025

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Proteomics and metabolomics changes after diet intervention

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

    5 weeks

Study Arms (1)

healty subject

EXPERIMENTAL
Other: diet

Interventions

dietOTHER

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

healty subject

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 30, 2021

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

December 31, 2022

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)