Healthy subjects
Conditions
Interventions
Consume 500ml/day of unsweetened carbonated water for 8 weeks
Consume 500ml/day of placebo foods for 8 weeks
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese men and women aged 20 to 60 years old at the time of consent 2) Healthy individuals not undergoing any medical treatment or medication(Except when using medication as needed) 3) Drinking less than 500ml of unsweetened carbonated water per week 4) Those who are able to record the specified information 5) Those who have been fully informed of the purpose and content of the study and have given their voluntary consent 6) Those who use cigarettes or heated tobacco products 7) Those who smoke 10 or more cigarettes per day 8) Those who intend to quit smoking 9) Those whose daily smoking volume does not fluctuate much
Exclusion criteria
Exclusion criteria: 1) Those with drug or food allergies 2) Those who dislike the study foods 3) Pregnant or breastfeeding people 4) Those who cannot refrain from taking foods for specified health uses, functional foods, or other so-called health foods during the study period 5) Those who cannot take the study foods as instructed 6) Those who participating in other clinical trials, research, or clinical studies 7) Those who the principal investigator deems inappropriate 8) Those using smoking cessation clinics/smoking cessation medications, etc. 9) Those whose number of cigarettes smoked has been restricted by a doctor, etc. 10) Those using things other than medicine (foods, drinks, supplements, etc.) to reduce the number of cigarettes smoked
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cigarettes smoked | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychological nicotine dependence, physical nicotine dependence, exhaled CO concentration/carboxyhemoglobin level | — |
Countries
Japan
Contacts
Public ContactAya Takahashi
Macromill, Inc. Clinical Trial Unit, Life Science Division
Outcome results
None listed