NCT06389604

Brief Summary

As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

March 5, 2024

Last Update Submit

April 24, 2024

Conditions

Body Temperature ChangesHeat ExposureHeat StressHyperthermia

Keywords

heat acclimationthermoregulationheat exposurecardiovascular

Outcome Measures

Primary Outcomes (1)

  • Core temperature

    thermophysiological parameters (ºC)

    1 week of heat acclimation

Secondary Outcomes (10)

  • Skin temperature

    1 week of heat acclimation

  • Sweat rate

    1 week of heat acclimation

  • Heart rate

    1 week of heat acclimation

  • Blood pressure

    1 week of heat acclimation

  • Skin blood flow

    1 week of heat acclimation

  • +5 more secondary outcomes

Study Arms (1)

Heat acclimation

EXPERIMENTAL

Passive heat exposure (29-35ºC; 6h/day for 7 days) in combination with 30min/day low-to-moderate intensity cycling.

Other: Heat acclimation

Interventions

Heat acclimationOTHER

Daily repeated heat exposure to assess the effects of combined passive and active heat acclimation

Heat acclimation

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males and females
  • to 80 years
  • BMI 25-30 kg/m2
  • Sedentary (\<2h exercise/week)

You may not qualify if:

  • Presence of chronic cardiovascular disease, as determined by medical history and physical examination
  • Participating in a structured exercise program
  • Taking hot baths/saunas regularly
  • Travelled for a prolonged time to destinations with elevated temperatures the last 3 months
  • Pre-existing T2DM
  • Blood donation within a month of study initiation
  • People with low haemoglobin concentration (males: Hb = 13.5-17.5 g/dL, females: Hb = 11.5-15.5 g/dL)
  • Recent participation in biomedical study (less than 1 month)
  • Using any medication that may influence glucose or lipid metabolism (beta-blockers, thyroid medications, stimulants, antidepressants, anticoagulants)
  • Smoking or abuse of alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pallubinsky H, Schellen L, Kingma BRM, Dautzenberg B, van Baak MA, van Marken Lichtenbelt WD. Thermophysiological adaptations to passive mild heat acclimation. Temperature (Austin). 2017 Mar 10;4(2):176-186. doi: 10.1080/23328940.2017.1303562. eCollection 2017.

    PMID: 28680933BACKGROUND

  • Pallubinsky H, Phielix E, Dautzenberg B, Schaart G, Connell NJ, de Wit-Verheggen V, Havekes B, van Baak MA, Schrauwen P, van Marken Lichtenbelt WD. Passive exposure to heat improves glucose metabolism in overweight humans. Acta Physiol (Oxf). 2020 Aug;229(4):e13488. doi: 10.1111/apha.13488. Epub 2020 Jun 1.

    PMID: 32359193BACKGROUND

MeSH Terms

Conditions

Body Temperature ChangesHeat Stress DisordersHyperthermia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Hannah Pallubinsky, Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

  • Guy Plasqui

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Pappa, M.Sc.

CONTACT

+31433882507sofia.pappa@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No blinding due to nature of intervention
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Non-randomized, within subject experiemental trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

April 29, 2024

Study Start

May 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share