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

Primary Purpose

Cardiovascular Risk Factor, Metabolic Complication, Endocrine; Complications

Status
Unknown status
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Cold water immersion
No cold water immersion
Sponsored by
Pavol Jozef Safarik University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • 1st Department of Internal medicine, L. Pasteur University Hospital in KošiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Group

Sham control

Arm Description

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

Control without CWI exposition

Outcomes

Primary Outcome Measures

Body mass index
BMI kg/m2
Change in total cholesterol from baseline
percentual change in total cholesterol (mmoL/L)
Concentrations of PCSK9, hsCRP and other inflammation markers
mmol/l
cIMT
mm
PWV
m/s
Beta
AU
SF
mm
VF
mm
Fatty acid profile
mol/l

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
November 26, 2020
Sponsor
Pavol Jozef Safarik University
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1. Study Identification

Unique Protocol Identification Number
NCT04642066
Brief Title
Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters
Official Title
Effect of Repeatedly Applied Cold Water Immersion on Subclinical Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters of Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pavol Jozef Safarik University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Metabolic Complication, Endocrine; Complications, Immune System Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
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
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Control without CWI exposition
Intervention Type
Other
Intervention Name(s)
Cold water immersion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No cold water immersion
Intervention Description
People without cold water immersion
Primary Outcome Measure Information:
Title
Body mass index
Description
BMI kg/m2
Time Frame
6 months
Title
Change in total cholesterol from baseline
Description
percentual change in total cholesterol (mmoL/L)
Time Frame
6 months
Title
Concentrations of PCSK9, hsCRP and other inflammation markers
Description
mmol/l
Time Frame
6 months
Title
cIMT
Description
mm
Time Frame
6 months
Title
PWV
Description
m/s
Time Frame
6 months
Title
Beta
Time Frame
6 months
Title
AU
Time Frame
6 months
Title
SF
Description
mm
Time Frame
6 months
Title
VF
Description
mm
Time Frame
6 months
Title
Fatty acid profile
Description
mol/l
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Tóth, MUDr., PhD
Phone
00421918038
Email
stefan.toth@upjs.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Tóth, MUDr., PhD
Organizational Affiliation
Pavol Joef Safárik University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Internal medicine, L. Pasteur University Hospital in Košice
City
Košice
ZIP/Postal Code
04011
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Janicko, MD, PhD
Phone
+42155640
Ext
3515
Email
interna1.snp@unlp.sk

12. IPD Sharing Statement

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

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