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Recruiting NCT06432504

Variation in the Impact of Coffee on the Metabolic Rate

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caffeine content.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS).

Interventions

  • Other Caffeine content
    Participants will drink the same volume of coffee with different amounts of caffeine.

Primary outcome measures

  • Resting energy expenditure [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Urine metabolites [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Expired gases [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
Secondary outcome measures (11)
  • Body temperature [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Electrocardiogram (ECG) [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Blood samples [Time frame: Baseline : empty stomach On the first moring of experiment.]
  • Blood pressure [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Height [Time frame: On the first moring of experiment, it lasts 5 minutes.]
  • Body weight [Time frame: On the first moring of experiment, it lasts 5 minutes.]
  • Fat mass [Time frame: On the second moring of experiment, it lasts 10 minutes.]
  • Fat free mass [Time frame: On the first moring of experiment, it lasts 5 minutes.]
  • Bone mass [Time frame: On the first moring of experiment, it lasts 10 minutes.]
  • Heart rate [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
  • Body water, extracellular fluid and intracelluar fluid [Time frame: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]

Eligibility criteria

Inclusion criteria

Healthy adults 18-40 years old

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Shenzhen Institute of Advanced Technology — Shenzhen

Identifiers

NCT: NCT06432504 · SIAT IRB 221115H0629

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗