Effects of Snuff and/or Red Wine om Metabolic Rate

NCT ID: NCT04547426

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Metabolic Rate Hunger Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
We use non-alcoholic or alcohol containing wine and regular or nicotine free snuff

Study Groups

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red wine and snuff

regular red wine and moist snuff

Group Type ACTIVE_COMPARATOR

Wine with or without alcohol and snuff with or without nicotine

Intervention Type OTHER

Two by two factorial of wine and snuff with meals

red wine and nicotine-free snuff

regular red wine and nicotine-free snuff

Group Type ACTIVE_COMPARATOR

Wine with or without alcohol and snuff with or without nicotine

Intervention Type OTHER

Two by two factorial of wine and snuff with meals

non alcoholic red wine and regular moist snuff

non alcoholic red wine and regular moist snuff with nicotine

Group Type ACTIVE_COMPARATOR

Wine with or without alcohol and snuff with or without nicotine

Intervention Type OTHER

Two by two factorial of wine and snuff with meals

non-alcoholic red wine and nicotine-free snuff

Non-alcoholic red wine and nicotine-free snuff

Group Type PLACEBO_COMPARATOR

Wine with or without alcohol and snuff with or without nicotine

Intervention Type OTHER

Two by two factorial of wine and snuff with meals

Interventions

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Wine with or without alcohol and snuff with or without nicotine

Two by two factorial of wine and snuff with meals

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Fredrik H Nystrom

professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine and Health Sciences

Linköping, Sverige, Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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Fredrik Nyström, MD

Role: primary

+132237749

Other Identifiers

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EPN2020-00839

Identifier Type: -

Identifier Source: org_study_id

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