NCT06825962

Brief Summary

Certain populations, such as industrial workers and endurance athletes are particularly susceptible to dehydration due to exposure to heat for long periods of time causing evaporative water loss via sweating. The physical and cognitive decrements associated with dehydration have been widely researched, however the effect of dehydration on metabolism is lesser known. As climate change is causing temperatures to rise, and metabolic diseases such as type 2 diabetes are more common, the effect of dehydration on metabolism, specifically glycemic response to meals, needs to be established for future recommendations in clinical, environmental and athletic settings. Therefore, the aim of this study is to investigate the effect of acute exercise-induced dehydration on subsequent metabolic responses to feeding (i.e. glycaemia and insulinaemia).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 4, 2025

Last Update Submit

February 10, 2025

Conditions

Glycaemia

Keywords

HydrationDehydrationHypohydrationGlycemiaGlycaemiaGlucose control

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose

    Measured using colorimetric assay from venous blood samples

    6 hours

Secondary Outcomes (11)

  • Plasma insulin

    6 hours

  • Plasma osmolality

    6 hours

  • Plasma volume change

    6 hours

  • Urine volume

    6 hours

  • Body mass

    6 hours

  • +6 more secondary outcomes

Other Outcomes (5)

  • N-back task for working memory (cognitive function)

    3 hours

  • Go/no-go task for response inhibition (cognitive function)

    3 hours

  • Oculomotor function antisaccade task

    3 hours

  • +2 more other outcomes

Study Arms (2)

Euhydrated

EXPERIMENTAL

Light exercise in a hot environment with water ingested to fully replace sweat losses and maintain euhydration.

Other: Water intake

Hypohydrated

EXPERIMENTAL

Light exercise in a hot environment with water restricted to induce hypohydration of \~3% body mass through sweating.

Other: Water restriction

Interventions

Water intakeOTHER

Water ingested to fully replace sweat losses during exercise.

Euhydrated
Water restrictionOTHER

Water restriction to induce hypohydration of \~3% body mass through sweat losses during exercise.

Hypohydrated

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Generally fit and healthy
  • Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week

You may not qualify if:

  • \< 18 or \> 45
  • Any health condition that may affect study outcomes (e.g., endocrine/liver/renal/cardiovascular disease)
  • Any morbidity that affects ability to cycle
  • Smoker or vaper

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE113TU, United Kingdom

Location

MeSH Terms

Conditions

Dehydration

Interventions

Drinking

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Lewis J James, PhD

CONTACT

+44 (0) 1509 226305L.James@lboro.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 13, 2025

Study Start

March 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)