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NCT Number: NCT06432504

Variation in the Impact of Coffee on the Metabolic Rate

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Institute of Advanced Technology

Shenzhen, Guangdong, 518055, China

Location status: Recruiting

Location contact

Hannan Zhang, Bachelor

CONTACT

[email protected]

13371016641

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine content

Other

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

Primary outcomes

  1. Resting energy expenditure

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

    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.

  2. Urine metabolites

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

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

  3. Expired gases

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

    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.

Secondary outcomes

  1. Body temperature

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

    Body temperature of participants will be measured by body temperature patch (RIT-P02-MED) before and after coffee consumption.

  2. Electrocardiogram (ECG)

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

    ECG of participants will be measured by Amu ECG belt before and after coffee consumption, the changes in P wave, PR interval, PR segment, QRS wave group, J point, ST segment, T wave, QT interval, and U wave will be observe.

  3. Blood samples

    Time frame: Baseline : empty stomach On the first moring of experiment.

    Venous blood collected by nurses, blood samples will be used for whole genome exon sequencing to analyze single nucleotide polymorphisms.

  4. Blood pressure

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

    Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer before and after coffee consumption.

  5. Height

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

    Height will be measured by seca 217 stable stadiometer.

  6. Body weight

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

    Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).

  7. Fat mass

    Time frame: On the second moring of experiment, it lasts 10 minutes.

    Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).

  8. Fat free mass

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

    Fat free mass will be Bioimpedance Analysis (TANITA, MC-980).

  9. Bone mass

    Time frame: On the first moring of experiment, it lasts 10 minutes.

    Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).

  10. Heart rate

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

    Heart rate will be measured by Omron sphygmomanometer.

  11. Body water, extracellular fluid and intracelluar fluid

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

    Body water, extracellular fluid and intracelluar fluid will be measured by Bioimpedance Analysis (TANITA, MC-980).

Study contacts

Contact information is provided by the study sponsor or research team.

Huanan Zhang, Bachelor

CONTACT

[email protected]

13371016641

John R Speakman, PhD

CONTACT

[email protected]

13466654659

Sponsors and collaborators

Lead sponsor

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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