Effects of Snuff and/or Red Wine om Metabolic Rate

Metabolic Effects of Snuff and Red Wine

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.

Study Overview

• Status: Recruiting
• Conditions: Insulin Sensitivity; Hunger; Metabolic Rate
• Intervention / Treatment: Other: Wine with or without alcohol and snuff with or without nicotine

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 Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Sverige
    • Linköping, Sverige, Sweden, 60580
      • Recruiting
      • Faculty of Medicine and Health Sciences
      • Contact: Fredrik Nyström, MD; Phone Number: +132237749; Email: fredrik.nystrom@regionostergotland.se
      • Principal Investigator: Fredrik H Nystrom, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: No significant disease -

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of metabolic rate	Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sense of appetite	determination of the hormones ghrelin and GLP-1 in serum	4 hours

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: EPN2020-00839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are no such plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No