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Effects of Snuff and/or Red Wine om Metabolic Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547426
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

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.

Condition or disease Intervention/treatment Phase
Metabolic Rate Hunger Insulin Sensitivity Other: Wine with or without alcohol and snuff with or without nicotine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: We use non-alcoholic or alcohol containing wine and regular or nicotine free snuff
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Snuff and Red Wine
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: red wine and snuff
regular red wine and moist snuff
Other: Wine with or without alcohol and snuff with or without nicotine
Two by two factorial of wine and snuff with meals

Active Comparator: red wine and nicotine-free snuff
regular red wine and nicotine-free snuff
Other: Wine with or without alcohol and snuff with or without nicotine
Two by two factorial of wine and snuff with meals

Active Comparator: non alcoholic red wine and regular moist snuff
non alcoholic red wine and regular moist snuff with nicotine
Other: Wine with or without alcohol and snuff with or without nicotine
Two by two factorial of wine and snuff with meals

Placebo Comparator: non-alcoholic red wine and nicotine-free snuff
Non-alcoholic red wine and nicotine-free snuff
Other: Wine with or without alcohol and snuff with or without nicotine
Two by two factorial of wine and snuff with meals




Primary Outcome Measures :
  1. metabolic rate [ Time Frame: 4 hours ]
    Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake


Secondary Outcome Measures :
  1. appetite [ Time Frame: 4 hours ]
    determination of the hormones ghrelin and GLP-1 in serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: No significant disease -

Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547426


Locations
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Sweden
Faculty of Medicine and Health Sciences Recruiting
Linköping, Sverige, Sweden, 60580
Contact: Fredrik Nyström, MD    +132237749    fredrik.nystrom@regionostergotland.se   
Principal Investigator: Fredrik H Nystrom, professor         
Sponsors and Collaborators
University Hospital, Linkoeping
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Responsible Party: Fredrik H Nystrom, professor, MD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT04547426    
Other Study ID Numbers: EPN2020-00839
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no such plans

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action