Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters

• ClinicalTrials.gov Identifier: NCT04642066
• Recruitment Status: Recruiting
• First Posted: November 24, 2020
• Last Update Posted: November 30, 2020
• Sponsor: Pavol Jozef Safarik University
• Information provided by (Responsible Party): Martin Janičko, Pavol Jozef Safarik University

Study Description

Brief Summary:

The impact of the environment on human health is considerable. An important factor is the effect of temperature on the human body, where either the effects of short-term exposure to extreme temperatures (cryotherapy, sauna, etc.) or the long-term environmental impact are monitored.

The study was focused on research of the long-term effect of repeated CWI on atherogenesis, lipid parameters and fat distribution.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Risk Factor; Metabolic Complication; Endocrine; Complications; Immune System Diseases	Other: Cold water immersion; Other: No cold water immersion	Not Applicable

Detailed Description:

This study was designed as a cohort observational studyfollowing the group of volunteers practicing CWI. Totally forty volunteers agreed to participate in the study by signing the informed consent, approved by the local ethics committee of UPJŠ Košice. Volunteers were examined in Cardiology and General Medicine outpatient clinics of Faculty of medicine, UPJŠ Košice (1st Department of Internal Medicine; outpatient clinics of Medicomp Košice Ltd.). They underwent the anamnesis and examination with a focus in the first step on matching the inclusion criteria: SCORE for the assessment of the cardiovascular risk as low (≤1%), patients without the suspected diagnosis of the familialhypercholesterolemia, respectively with TC level above 8 mmol/L, respectively TG concentrations above 2.3 mmol/L, male gender, age between 21 and 60, signed informed consent to participate in the study.

Patients with one or more exclusion criteria were not included: volunteers with lipid-lowering therapy or those that received hypolipidemics in the period shorter than 3 months before the study, values of blood lipids outside the inclusion criteria, glucose intolerance and DM,presence of advanced cardiovascular (plague or coronary artery disease, TIA, stroke, etc.) or chronic inflammatory diseases, infection or diseases possible affecting measured parameters and significant lifestyle changes in the last period of 6 months before the CWI.

After the initial examination, 35 volunteers fulfilled the criteria. Volunteers of the study underwent controlled, repeated CWI (5 months 15/11/18 - 15/03/19)based on a following pre-prepared protocol in the cooperation of our physicians and the sport club: Full body CWI in open standing, except the head (same location, timing), frequency three times a weekin the duration of 7-10 minutes. Swimming was permitted. Volunteers must not use neoprene aids (gloves, shoes), caps were allowed. Volunteers should be in the final phase submerged in water, above which there should only be the head and neck. The upper limbs were below the water surface. Non-neoprene footwear was permitted. Volunteers entered the water continuously without stopping. The time of stay in water was calculated from the first contact of the foot with water. On average, the whole body needed to be immersed in water within 30 seconds. The entire study was performed in the nearby lake, where all participants in the active arm were exposed to the same weather and water conditions, which were monitored. Volunteers who did not follow the protocol in more than 15% of the episodes, respectively, with weight, fat or muscle mass changes over 5%, with significant dietary changes were excluded from the study. Equivalent sham control group (N=30) was included fulfilling the inclusion criteria, without the CWI.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Repeatedly Applied Cold Water Immersion on Subclinical Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters of Volunteers
• Actual Study Start Date: October 25, 2018
• Estimated Primary Completion Date: December 30, 2020
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active Group; Healthy volunteers were followed during the 5-month CWI exposition under standard conditions (three times per week 7-10 min). Neoprene equipment was not allowed; volunteers with followed weight or muscle mass changes over 5% were excluded	Other: Cold water immersion; Full body CWI in open standing, except the head (same location, timing), frequency three times a week in the duration of 7-10 minutes. Swimming was permitted. Volunteers must not use neoprene aids (gloves, shoes), caps were allowed. Volunteers should be in the final phase submerged in water, above which there should only be the head and neck. The upper limbs were below the water surface. Non-neoprene footwear was permitted. Volunteers entered the water continuously without stopping. The time of stay in water was calculated from the first contact of the foot with water. On average, the whole body needed to be immersed in water within 30 seconds.
Sham Comparator: Sham control; Control without CWI exposition	Other: No cold water immersion; People without cold water immersion

Outcome Measures

Primary Outcome Measures :

1. Body mass index [ Time Frame: 6 months ]
   BMI kg/m2
2. Change in total cholesterol from baseline [ Time Frame: 6 months ]
   percentual change in total cholesterol (mmoL/L)
3. Concentrations of PCSK9, hsCRP and other inflammation markers [ Time Frame: 6 months ]
   mmol/l
4. cIMT [ Time Frame: 6 months ]
   mm
5. PWV [ Time Frame: 6 months ]
   m/s
6. Beta [ Time Frame: 6 months ]
7. AU [ Time Frame: 6 months ]
8. SF [ Time Frame: 6 months ]
   mm
9. VF [ Time Frame: 6 months ]
   mm
10. Fatty acid profile [ Time Frame: 6 months ]
    mol/l

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

without cardiovascular and metabolic disease cold water immersion

Exclusion Criteria:

cancer inflammatory diseases cardovascular diseases tuberculosis renal and hepatic insufficiency pregnancy cardiovascular diseases obesity metabolic syndrome lymphoproliferative disorders liver transplantation in the past suspected. chronic infection in risk locations

Contacts and Locations

Contacts

Contact: Stefan Tóth, MUDr., PhD; 00421918038; stefan.toth@upjs.sk

Locations

Slovakia

1st Department of Internal medicine, L. Pasteur University Hospital in Košice; Recruiting

Košice, Slovakia, 04011

Contact: Martin Janicko, MD, PhD +42155640 ext 3515 interna1.snp@unlp.sk

Sponsors and Collaborators

Pavol Jozef Safarik University

Investigators

• Principal Investigator: Stefan Tóth, MUDr., PhD; Pavol Joef Safárik University, Faculty of Medicine

More Information

• Responsible Party: Martin Janičko, Assistant Professor, Pavol Jozef Safarik University
• ClinicalTrials.gov Identifier: NCT04642066
• Other Study ID Numbers: LF UPJS
• First Posted: November 24, 2020
• Last Update Posted: November 30, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atherosclerosis; Immune System Diseases; Inflammation; Pathologic Processes; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases