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Clinical Trials/NCT04547426
NCT04547426UnknownNot Applicable

Metabolic Effects of Snuff and Red Wine

University Hospital, Linkoeping1 site in 1 country14 target enrollmentStarted: August 31, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
level of metabolic rate

Study Overview

Brief Summary

About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured every hour for four hours on each occasion starting in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal.

Detailed Description

About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured measured before the meal and then every hour for a total of four hours on each occasion that starts in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal. Since there are four possible combinations of the wine and the snuff, all participants do the test on four occasions. Except for metabolic rate we will also analyze hormone responses regarding appetite or hunger.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Masking Description

We use non-alcoholic or alcohol containing wine and regular or nicotine free snuff

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •No significant disease -

Exclusion Criteria

  • •known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish

Arms & Interventions

red wine and snuff

Active Comparator

regular red wine and moist snuff

Intervention: Wine with or without alcohol and snuff with or without nicotine (Other)

red wine and nicotine-free snuff

Active Comparator

regular red wine and nicotine-free snuff

Intervention: Wine with or without alcohol and snuff with or without nicotine (Other)

non alcoholic red wine and regular moist snuff

Active Comparator

non alcoholic red wine and regular moist snuff with nicotine

Intervention: Wine with or without alcohol and snuff with or without nicotine (Other)

non-alcoholic red wine and nicotine-free snuff

Placebo Comparator

Non-alcoholic red wine and nicotine-free snuff

Intervention: Wine with or without alcohol and snuff with or without nicotine (Other)

Outcomes

Primary Outcomes

level of metabolic rate

Time Frame: 4 hours

Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake

Secondary Outcomes

  • sense of appetite(4 hours)

Investigators

Sponsor
University Hospital, Linkoeping
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fredrik H Nystrom

professor, MD

University Hospital, Linkoeping

Study Sites (1)

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