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NCT04547426 Clinical Trial

Effects of Snuff and/or Red Wine om Metabolic Rate

Insulin Sensitivity Clinical Trial

Official title:
Metabolic Effects of Snuff and Red Wine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04547426
Other study ID # EPN2020-00839
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2020
Est. completion date August 2022

Study information
Verified date October 2021
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 14
Est. completion date August 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: No significant disease - Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Wine with or without alcohol and snuff with or without nicotine
Two by two factorial of wine and snuff with meals

Locations
Country Name City State
Sweden Faculty of Medicine and Health Sciences Linköping Sverige

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary level of metabolic rate Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake 4 hours
Secondary sense of appetite determination of the hormones ghrelin and GLP-1 in serum 4 hours
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