The Effect of Hydration Status on Glycemic Control and Appetite Regulation

NCT02841449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-06-22

Study results available
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Summary

The aim of this study is to investigate whether hydration status affects blood sugar control and appetite regulation. In order to do this, participants will undergo a monitoring phase whereby their weight, diet and physical activity are monitored, followed by a dehydration protocol involving fluid restriction and sitting in a heat tent. In one arm of the trial, participants will remain dehydrated for the remainder of the day (i.e. after the heat tent) by having their fluid intake restricted, and in the other arm of the trial, participants will be rehydrated by consuming the necessary amount of plain water. All participants will undergo both arms of the trial, the order of which will be chosen randomly.

Several measures will be taken throughout the trial. Before participants go into the heat tent, they will provide a urine sample (for baseline hydration status as indicated by urine osmolality), a blood sample (for glucose, insulin, arginine vasopressin,/copeptin, ghrelin and serum osmolality and plasma volume), and have a peripheral quantitative computer tomography scan of their thigh to indicate muscle size. On the day proceeding the heat tent, participants will have these measures repeated, along with metabolic rate before consuming a 75 g glucose drink, followed by 15 minutely blood samples and hourly metabolic rate measures for 120 minutes (i.e. an oral glucose tolerance test; OGTT). Following this, participants will be presented with a large bowl of pasta and sauce and will be instructed to eat until satisfied (maximum 30 min). Blood samples will be taken every 10 minutes for 60 minutes following the meal.

Participants also have the option to opt-in to have a muscle biopsy taken. This will be taken before and \~120 minutes after the glucose drink.

Conditions

  • Healthy

Interventions

BEHAVIORAL

Hypohydrated

Participants remain hypohydrated after the heat tent procedure

BEHAVIORAL

Rehydrated

Participants rehydrate after the heat tent procedure

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER
  • Loughborough University

    collaborator OTHER
  • European Hydration Institute

    collaborator OTHER
  • Economic and Social Research Council, United Kingdom

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • University of Bath

    lead OTHER

Principal Investigators

  • Harriet A Carroll, MRes · University of Bath

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841449 on ClinicalTrials.gov