Snus and Home Blood Pressure

Sponsor

University Hospital, Linkoeping (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06019910

Collaborator

(none)

Enrollment

Arm

15.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.

28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Dyslipidemias Dysglycemia Obesity	Other: Snus with or without tobacco	N/A

Detailed Description

Both elevated blood pressure (BP) and cigarette smoking increases the risk of cardiovascular disease. Nicotine, through effects on the nervous system and catecholamine release, increases BP and heart rate, peaking 5-10 minutes after exposure, after which tolerance to nicotine reduces its hemodynamic effects. Smoking also increases energy expenditure, but studies on smoking and long-term metabolism have shown conflicting results.

28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation for 3 months. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation. Furthermore, for participants which relapse in snus use, the same measurements will be followed for an additional 3 months. Home blood pressure will be measured daily, and participants will also report the amount of snus use each day. At week 0, 4 and 12 of snus cessation and snus relapse, the following measurements will also be made: body weight as well as plasma glucose, blood glycated hemoglobin (HbA1c), serum insulin, plasma lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides), plasma hsCRP, plasma creatinine, plasma sodium, and plasma potassium.

As reimbursement, participants will receive (at least) 1000 Swedish krona (Approx 94 US dollar) for the drawing of blood tests. All participants will give written, informed consent prior to participation. The study will comply with the declaration of Helsinki and be approved by the Swedish Ethical Review Authority. Prior to commencement, the study will be registered at ClinicalTrials.gov.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effects of Snus on Home Blood Pressure and Metabolism

Anticipated Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Snus with or without tobacco Snus cessation followed by potential snus relapse	Other: Snus with or without tobacco At baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion.

Arm

Intervention/Treatment

Experimental: Snus with or without tobacco

Snus cessation followed by potential snus relapse

Other: Snus with or without tobacco

At baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion.

Outcome Measures

Primary Outcome Measures

Home blood pressure during snus cessation [4-12 weeks]
Change in home blood pressure from baseline until week 4 and week 12 respectively
Home blood pressure during snus relapse [4-12 weeks]
Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively

Secondary Outcome Measures

Body weight during snus cessation [4-12 weeks]
Change in body weight from baseline until week 4 and week 12 respectively
Concentration of plasma lipids during snus cessation [4-12 weeks]
Change in plasma lipids from baseline until week 4 and week 12 respectively
Concentration of fasting plasma glucose during snus cessation [4-12 weeks]
Change in fasting plasma glucose from baseline until week 4 and week 12 respectively
Concentration of fasting plasma insulin during snus cessation [4-12 weeks]
Change in fasting plasma insulin from baseline until week 4 and week 12 respectively
Concentration of blood HbA1c during snus cessation [4-12 weeks]
Change in blood HbA1c from baseline until week 4 and week 12 respectively
Body weight during snus relapse [4-12 weeks]
Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of plasma lipids during snus relapse [4-12 weeks]
Change in plasma lipids from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of fasting plasma glucose during snus relapse [4-12 weeks]
Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of fasting plasma insulin during snus relapse [4-12 weeks]
Change in fasting plasma insulin from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of blood HbA1c during snus relapse [4-12 weeks]
Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

daily use (defined as at least once daily for at least 1 month) o snus
the ability to use online questionnaires written and answered in Swedish

Exclusion Criteria:

simultaneous use of any other nicotine or tobacco product (including cigarette smoking, e-cigarettes, and nicotine replacement therapy)
drug use (including cannabis)
alcohol dependence
known cardiovascular disease (including hypertension, previous myocardial infarction, stroke, peripheral arterial disease, or angina pectoris), kidney disease, hormonal disease (including diabetes mellitus) or eating disorder
current or planned pregnancy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Principal Investigator: Fredrik H Nyström, PhD, MD, Linkoeping University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fredrik H Nystrom, Professor of internal medicine and endocrinology, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT06019910

Other Study ID Numbers:

snus2023

First Posted:

Aug 31, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyslipidemias

Study Results

No Results Posted as of Sep 7, 2023