Effects of Snuff and/or Red Wine om Metabolic Rate

NCT04547426 | Unknown

• 1 other identifier: EPN2020-00839
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Rate; Hunger; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• level of metabolic rate

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

  4 hours

Secondary Outcomes (1)

• sense of appetite

  4 hours

Study Arms (4)

red wine and snuff

ACTIVE COMPARATOR

regular red wine and moist snuff

Other: Wine with or without alcohol and snuff with or without nicotine

red wine and nicotine-free snuff

ACTIVE COMPARATOR

regular red wine and nicotine-free snuff

Other: Wine with or without alcohol and snuff with or without nicotine

non alcoholic red wine and regular moist snuff

ACTIVE COMPARATOR

non alcoholic red wine and regular moist snuff with nicotine

Other: Wine with or without alcohol and snuff with or without nicotine

non-alcoholic red wine and nicotine-free snuff

PLACEBO COMPARATOR

Non-alcoholic red wine and nicotine-free snuff

Other: Wine with or without alcohol and snuff with or without nicotine

Interventions

Wine with or without alcohol and snuff with or without nicotine OTHER

Two by two factorial of wine and snuff with meals

non alcoholic red wine and regular moist snuff; non-alcoholic red wine and nicotine-free snuff; red wine and nicotine-free snuff; red wine and snuff

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Faculty of Medicine and Health Sciences

Linköping, Sverige, 60580, Sweden

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Wine; Ethanol; Tobacco, Smokeless; Nicotine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages; Alcohols; Organic Chemicals; Tobacco Products; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: We use non-alcoholic or alcohol containing wine and regular or nicotine free snuff
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 14, 2020
• Study Start: August 31, 2020
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)