Back to resultsEffects of Snuff and/or Red Wine om Metabolic Rate
Primary Purpose
Metabolic Rate, Hunger, Insulin Sensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Wine with or without alcohol and snuff with or without nicotine
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Rate
Eligibility Criteria
Inclusion Criteria: No significant disease -
Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish
-
Sites / Locations
- Faculty of Medicine and Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
red wine and snuff
red wine and nicotine-free snuff
non alcoholic red wine and regular moist snuff
non-alcoholic red wine and nicotine-free snuff
Arm Description
regular red wine and moist snuff
regular red wine and nicotine-free snuff
non alcoholic red wine and regular moist snuff with nicotine
Non-alcoholic red wine and nicotine-free snuff
Outcomes
Primary Outcome Measures
level of metabolic rate
Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake
Secondary Outcome Measures
sense of appetite
determination of the hormones ghrelin and GLP-1 in serum
Full Information
NCT ID
NCT04547426
First Posted
August 31, 2020
Last Updated
October 1, 2021
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT04547426
Brief Title
Effects of Snuff and/or Red Wine om Metabolic Rate
Official Title
Metabolic Effects of Snuff and Red Wine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Rate, Hunger, Insulin Sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
We use non-alcoholic or alcohol containing wine and regular or nicotine free snuff
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
red wine and snuff
Arm Type
Active Comparator
Arm Description
regular red wine and moist snuff
Arm Title
red wine and nicotine-free snuff
Arm Type
Active Comparator
Arm Description
regular red wine and nicotine-free snuff
Arm Title
non alcoholic red wine and regular moist snuff
Arm Type
Active Comparator
Arm Description
non alcoholic red wine and regular moist snuff with nicotine
Arm Title
non-alcoholic red wine and nicotine-free snuff
Arm Type
Placebo Comparator
Arm Description
Non-alcoholic red wine and nicotine-free snuff
Intervention Type
Other
Intervention Name(s)
Wine with or without alcohol and snuff with or without nicotine
Intervention Description
Two by two factorial of wine and snuff with meals
Primary Outcome Measure Information:
Title
level of metabolic rate
Description
Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
sense of appetite
Description
determination of the hormones ghrelin and GLP-1 in serum
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No significant disease -
Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish
-
Facility Information:
Facility Name
Faculty of Medicine and Health Sciences
City
Linköping
State/Province
Sverige
ZIP/Postal Code
60580
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Nyström, MD
Phone
+132237749
Email
fredrik.nystrom@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Fredrik H Nystrom, professor
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no such plans
Learn more about this trial
Effects of Snuff and/or Red Wine om Metabolic Rate
We'll reach out to this number within 24 hrs