Metabolic RateNCT04547426
Effects of Snuff and/or Red Wine om Metabolic Rate
A study testing Wine with or without alcohol and snuff with or without nicotine in people with Metabolic Rate and Hunger, run by University Hospital, Linkoeping at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Rate, Hunger, Insulin Sensitivity
- What is being tested?
- Wine with or without alcohol and snuff with or without nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2020to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Faculty of Medicine and Health Sciences
Linköping, Sverige, 60580
Fredrik Nyström, MD, +132237749, fredrik.nystrom@regionostergotland.se
Fredrik H Nystrom, professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Rate, Hunger, Insulin Sensitivity
- Being tested
- Wine with or without alcohol and snuff with or without nicotine
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wine with or without alcohol and snuff with or without nicotineOther
Two by two factorial of wine and snuff with meals
| Study group | Role | What they receive |
|---|---|---|
| red wine and snuff | Active comparator | regular red wine and moist snuff Receives: 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 Receives: 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 Receives: 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 Receives: Other: Wine with or without alcohol and snuff with or without nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of metabolic rate
Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake
Measured: 4 hours
Secondary outcomes (1)
sense of appetite
determination of the hormones ghrelin and GLP-1 in serum
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start31 Aug 2020
- Primary completionApr 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547426
- Sponsor's protocol ID
- EPN2020-00839
- Status last verified
- Oct 2021
- First submitted
- 31 Aug 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no such plans
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Snuff and Red Wine
- ClinicalTrials.gov ID
- NCT04547426
- Acronym / sponsor ID
- EPN2020-00839
- Conditions
- Metabolic Rate, Hunger, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| red wine and snuff | Active comparator | Other: Wine with or without alcohol and snuff with or without nicotineregular red wine and moist snuff |
| red wine and nicotine-free snuff | Active comparator | Other: Wine with or without alcohol and snuff with or without nicotineregular red wine and nicotine-free snuff |
| non alcoholic red wine and regular moist snuff | Active comparator | Other: Wine with or without alcohol and snuff with or without nicotinenon alcoholic red wine and regular moist snuff with nicotine |
| non-alcoholic red wine and nicotine-free snuff | Placebo comparator | Other: Wine with or without alcohol and snuff with or without nicotineNon-alcoholic red wine and nicotine-free snuff |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wine with or without alcohol and snuff with or without nicotineTwo by two factorial of wine and snuff with meals | Other | 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 |
Primary outcome
level of metabolic rate
Time frame: 4 hours
Measurement of metabolic rate by registration of CO2 in breath and the oxygen uptake
1 secondary outcome
sense of appetite
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No. There are no such plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Medicine and Health Sciences
Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wine with or without alcohol and snuff with or without nicotine in people with Metabolic Rate and Hunger, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of metabolic rate (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.