NCT03817944

Brief Summary

The purpose of this study is to research the changes of typical thermal processing food intervention on health outcome, metabolites, and gut microbiota, in order to explore the molecular mechanism of interaction between maillard reaction associated hazards and complex food matrix, and provide scientific basis and reference model for combining food nutrition and safety protection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

January 23, 2019

Last Update Submit

May 5, 2025

Conditions

Health

Keywords

body weightglucoselipidmetabolitesgut microbiota

Outcome Measures

Primary Outcomes (2)

  • Change in blood glucose from baseline

    8 weeks

  • Change in blood lipids from baseline

    8 weeks

Secondary Outcomes (3)

  • Urinary biomarkers levels of acrylamide, furans, and furfuryl alcohol

    8 weeks; 24 hours

  • Change of metabolites

    8 weeks

  • Change in gut microbiota

    8 weeks

Study Arms (3)

Warm Water

PLACEBO COMPARATOR

300 mL Warm Water per day for 8 weeks

Other: Warm Water

Caffeinated Coffee

EXPERIMENTAL

300 mL Caffeinated Coffee per day for 8 weeks

Other: Caffeinated Coffee

Decaffeinated Coffee

EXPERIMENTAL

300 mL Decaffeinated Coffee per day for 8 weeks

Other: Decaffeinated Coffee

Interventions

Warm WaterOTHER

300 mL Warm Water per day for 8 weeks

Warm Water
Caffeinated CoffeeOTHER

300 mL Caffeinated Coffee per day for 8 weeks

Caffeinated Coffee
Decaffeinated CoffeeOTHER

300 mL Decaffeinated Coffee per day for 8 weeks

Decaffeinated Coffee

Eligibility Criteria

Age17 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-smoking, non-occupational exposed healthy volunteers, 18.5\<BMI\<30 kg/m\^2, were screened. If the evaluation of disease history, blood biochemistry and blood routine was normal, the volunteers were considered healthy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang university

Hangzhou, China

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 28, 2019

Study Start

October 18, 2021

Primary Completion

December 18, 2021

Study Completion

December 31, 2021

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)