NCT06432504

Brief Summary

The purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
8mo left

Started Mar 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 Progress77%
Mar 2024Dec 2026

Study Start

First participant enrolled

March 6, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

April 2, 2024

Last Update Submit

May 21, 2024

Conditions

Healthy

Keywords

CoffeeCaffeineMetabolic rateCaffeine clearance

Outcome Measures

Primary Outcomes (3)

  • Resting energy expenditure

    Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (COSMED). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Resting energy expenditure will be measured before and after coffee consumption. The extra energy expenditure is equal to the resting energy expenditure after drinking coffee minus the resting energy expenditure before drinking coffee.

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

  • Urine metabolites

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

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

  • Expired gases

    Gases will be collected before and after coffee consumption, Gases will be measured by CO2 isotope analyzer (CCIA2-912) to observe the change of labelled CO2.

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

Secondary Outcomes (11)

  • Body temperature

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

  • Electrocardiogram (ECG)

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

  • Blood samples

    Baseline : empty stomach On the first moring of experiment.

  • Blood pressure

    On the first moring of experiment, it lasts 0.5 hours and 3 hours.

  • Height

    On the first moring of experiment, it lasts 5 minutes.

  • +6 more secondary outcomes

Study Arms (4)

caffeine content 100mg

EXPERIMENTAL

The participants will drink 180 mls coffee

Other: Caffeine content

caffeine content 200mg

EXPERIMENTAL

The participants will drink 180 mls coffee.

Other: Caffeine content

caffeine content 300mg

EXPERIMENTAL

The participants will drink 180 mls coffee

Other: Caffeine content

13C3 caffeine content 100mg

EXPERIMENTAL

The participants will drink 180 mls coffee (caffeine content 100mg) containing 13C labelled caffeine to trace the pattern of caffeine degradation.

Other: Caffeine content

Interventions

Caffeine contentOTHER

Participants will drink the same volume of coffee with different amounts of caffeine.

13C3 caffeine content 100mgcaffeine content 100mgcaffeine content 200mgcaffeine content 300mg

Eligibility Criteria

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

You may qualify if:

  • Healthy adults 18-40 years old

You may not qualify if:

  • Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc.
  • People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc.
  • Those who have recently lost weight for various medical reasons ( like cancer, etc.).
  • People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institute of Advanced Technology

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

13466654659j.speakman@abdn.ac.uk

Huanan Zhang, Bachelor

CONTACT

13371016641hnzhang2021@163.com

Study Design

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

Study Record Dates

First Submitted

April 2, 2024

First Posted

May 29, 2024

Study Start

March 6, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

CN(1)