## Protocol Section
### Identification Module
**NCT ID:** NCT06432504

**Brief Title:** Variation in the Impact of Coffee on the Metabolic Rate

**Official Title:** Variation in the Impact of Coffee on the Metabolic Rate

#### Organization Study ID Info
**ID:** SIAT IRB 221115H0629
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

#### Responsible Party

**Investigator Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

**Investigator Full Name:** John R. Speakman

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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).

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Coffee

- Caffeine

- Metabolic rate

- Caffeine clearance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel Assignment

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants will drink 180 mls coffee

**Intervention Names:**

- Other: Caffeine content

**Label:** caffeine content 100mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants will drink 180 mls coffee.

**Intervention Names:**

- Other: Caffeine content

**Label:** caffeine content 200mg

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** The participants will drink 180 mls coffee

**Intervention Names:**

- Other: Caffeine content

**Label:** caffeine content 300mg

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Intervention Names:**

- Other: Caffeine content

**Label:** 13C3 caffeine content 100mg

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 13C3 caffeine content 100mg

- caffeine content 100mg

- caffeine content 200mg

- caffeine content 300mg

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

**Name:** Caffeine content

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Resting energy expenditure

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

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

**Measure:** Urine metabolites

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

**Description:** 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.

**Measure:** Expired gases

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

#### Secondary Outcomes

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

**Measure:** Body temperature

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

**Description:** 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.

**Measure:** Electrocardiogram (ECG)

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

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

**Measure:** Blood samples

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

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

**Measure:** Blood pressure

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

**Description:** Height will be measured by seca 217 stable stadiometer.

**Measure:** Height

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

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

**Measure:** Body weight

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

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

**Measure:** Fat mass

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

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

**Measure:** Fat free mass

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

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

**Measure:** Bone mass

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

**Description:** Heart rate will be measured by Omron sphygmomanometer.

**Measure:** Heart rate

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

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

**Measure:** Body water, extracellular fluid and intracelluar fluid

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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** j.speakman@abdn.ac.uk

**Name:** John R Speakman, PhD

**Phone:** 13466654659

**Role:** CONTACT

**Contact 2:**

**Email:** hnzhang2021@163.com

**Name:** Huanan Zhang, Bachelor

**Phone:** 13371016641

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Email:** hnzhang2021@163.com

- **Name:** Hannan Zhang, Bachelor

- **Phone:** 13371016641

- **Role:** CONTACT

**Country:** China

**Facility:** Shenzhen Institute of Advanced Technology

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 518055

#### Overall Officials

**Official 1:**

**Affiliation:** Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

**Name:** John R Speakman, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000697

- Term: Central Nervous System Stimulants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010726

- Term: Phosphodiesterase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000058915

- Term: Purinergic P1 Receptor Antagonists

- ID: D000058914

- Term: Purinergic Antagonists

- ID: D000058905

- Term: Purinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5373

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M13629

- Name: Phosphodiesterase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: T370

- Name: Caffeine

- Relevance: HIGH

- As Found: 800

### Intervention Browse Module - Meshes

- ID: D000002110

- Term: Caffeine

### Misc Info Module

- Version Holder: 2024-05-31
