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

NCT04642066 | Suspended DMC

• 1 other identifier: LF UPJS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Metabolic Complication; Endocrine; Complications; Immune System Diseases

Outcome Measures

Primary Outcomes (10)

• Body mass index

  BMI kg/m2

  6 months

• Change in total cholesterol from baseline

  percentual change in total cholesterol (mmoL/L)

  6 months

• Concentrations of PCSK9, hsCRP and other inflammation markers

  mmol/l

  6 months

• cIMT

  mm

  6 months

• PWV

  m/s

  6 months

• Beta

  6 months

• AU

  6 months

• SF

  mm

  6 months

• VF

  mm

  6 months

• Fatty acid profile

  mol/l

  6 months

Study Arms (2)

Active Group

EXPERIMENTAL

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

Sham control

SHAM COMPARATOR

Control without CWI exposition

Other: No cold water immersion

Interventions

Cold water immersion OTHER

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.

Active Group

No cold water immersion OTHER

People without cold water immersion

Sham control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• without cardiovascular and metabolic disease cold water immersion

You may not qualify if:

• 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

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead

Study Sites (1)

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

Košice, 04011, Slovakia

Location

MeSH Terms

Conditions

Immune System Diseases

Study Officials

• Stefan Tóth, MUDr., PhD

  Pavol Joef Safárik University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: October 25, 2018
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

SL (1)