NCT06712511

Brief Summary

Obesity is a risk factor for chronic diseases, and improving energy expenditure is a way to prevent and treat obesity. The purpose of this project is to explore the relationship between the effect of coffee on energy expenditure and caffeine metabolism, which has important significance in the rational application of caffeine.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
44mo left

Started Oct 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress30%
Oct 2024Dec 2029

Study Start

First participant enrolled

October 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

November 26, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

CoffeeCaffeineEnergy expenditureCaffeine metabolism

Outcome Measures

Primary Outcomes (3)

  • Total energy expenditure

    Total energy expenditure will be measured by Chamber (OMNICAL).

    2 days

  • The concentration of caffeine and its metabolites in urine

    The contents of caffeine and it's metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).

    2 days

  • The concentration of caffeine and its metabolites in serum

    The concentration of caffeine and its metabolites in serum will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).

    1 day

Secondary Outcomes (13)

  • Body temperature

    2 days

  • Electrocardiogram (ECG)

    2 days

  • Blood pressure

    2 days

  • Height

    The morning of the first day of the experiment, 5 mins

  • Body weight

    The morning of the first day of the experiment, 5 mins

  • +8 more secondary outcomes

Study Arms (2)

water

EXPERIMENTAL

The participants will drink 200 ml water four times at 1 hour intervals.

Other: Caffeine content

coffee

EXPERIMENTAL

The participants will drink 200 ml coffee four times at 1 hour intervals.

Other: Caffeine content

Interventions

Participants will drink the same volume of water or coffee, caffeine content is 2mg/kg by body weight.

coffeewater

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults.
  • Must be able to drink coffee.

You may not qualify if:

  • Diabetes.
  • Hypoglycemia.
  • Gout.
  • Osteoporosis.
  • Gastric ulcer.
  • Pancreatitis.
  • Intestinal obstruction.
  • Blood phobia.
  • Pathological hypo or hyper tension.
  • Impaired glucose tolerance.
  • Claustrophobia.
  • HIV,etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Shenzhen, Guangdong, 518055, China

RECRUITING

Study Officials

  • John R Speakman, PhD

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    STUDY CHAIR

Central Study Contacts

John R Speakman, PhD

CONTACT

Huanan Zhang, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

October 23, 2024

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations