A study to assess the Breezing Med™ metabolic device following stimulant use

Not Applicable

Completed

• Conditions: Metabolic assessment; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN38539210
• Lead Sponsor: British American Tobacco (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-05
• Study Completion: 2021-09-24
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Healthy male or female subjects, between 25 and 35 years of age, inclusive. An effort will be made to recruit an even split of subjects by gender, with an even distribution around the mean age of participants also
2. Subjects with a body mass index (BMI) of 18.5-24.9 kg/m²
3. Subjects who are current daily users of conventional factory-made cigarettes and/or roll your own cigarettes (10 cigarettes per day) and who have done so for at least 3 years. Subjects should also be familiar with using e-cigarettes (i.e. have used e-cigarettes over a period of greater than 1 month within the last 2 years)
4. Subjects who are regular caffeine consumers of the equivalent of >1 and =5 cups/day of coffee/tea/energy drink
5. Subjects who are willing to comply with the study protocol
6. Subjects must be available to complete the study
7. Subjects must provide written informed consent to participate in the study

Exclusion Criteria

1. Subjects who self-report to have an acute illness (e.g. upper respiratory tract infection, viral infection, etc) requiring treatment within 4 weeks prior to Screening or on admission
2. Subjects who self-report to have any clinically significant abnormalities or underlying health conditions
3. Subjects who are self-reported non-inhalers (smokers/vapers who draw smoke/aerosol from the cigarette/e-cigarette into the mouth and throat but who do not inhale)
4. Female subjects who are pregnant and breastfeeding or lactating
5. Subjects who, prior to enrolment, are planning to quit/alter smoking/vaping within the duration of the study (to follow-up telephone call). All subjects will be informed that they are free to quit smoking/vaping and withdraw from the study at any time.
6. Self-reported evidence of metabolic dysfunction
7. A self-reported significant history of drug or alcohol abuse [defined as the consumption of more than 14 units for male and female subjects of alcohol a week] within the past 2 years
8. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting metabolic rate (RMR) assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)

Secondary Outcome Measures

Name	Time	Method
1. RQ (respiratory quotient) assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)<br>2. VCO2 ml/min assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)<br>3. VO2 ml/min assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)<br>4. Breath frequency/min assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)<br>5. Tidal volume ml assessed via the Breezing Med™ device at set timepoints over a 1 hour and 10 minute timeframe (0-10 min, 15-25 min, 30-40 min, 45-55 min, 60-70 min)