The Effect of Hydration Status on Glycemic Control and Appetite Regulation

NCT02841449 | Completed Results

• 1 other identifier: 16/SW/0057
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydration; Glycemic control; Appetite; Endocrinology

Outcome Measures

Primary Outcomes (1)

• Glycemic Response

  Primary analysis is time trends (i.e. ANOVA effects), supported by indices of the glycemic response (e.g. iAUC, time to peak). Blood was taken pre-muscle biopsy (if participants opted in for a muscle biopsy), before consuming the glucose drink (after the biopsy, where applicable), then at 15 minutely samples for 120 minutes. After the meal test, blood was drawn at 10 minutely intervals for 60 minutes, starting 30 minutes after commencement of eating.

  Measured on day 5 on both trial arms, using the blood sample drawn before the glucose beverage is consumed and the blood samples drawn for the subsequent 120 minutes

Secondary Outcomes (8)

• Insulinemic Response

  Measured on day 5 on both trial arms, using the blood sample drawn before the glucose beverage is consumed and the blood samples drawn for the subsequent 120 minutes

• Arginine Vasopressin and Copeptin Response

  Measured on day 5 on both trial arms, using the blood sample drawn before the glucose beverage is consumed and the blood samples drawn for the subsequent 120 minutes (please note: may measure copeptin as a marker of arginine vasopressin)

• Ghrelin Response

  Measured on day 5 on both trial arms, using the blood sample drawn before the participant starts eating the buffet and the subsequent post-buffet blood samples

• Energy Intake

  Measured on day 5 on both trial arms from the pasta test meal

• Metabolic Rate

  Using the metabolic rate data collected on day 5 on both trial arms

Other Outcomes (5)

• Serum Osmolality

  Measured from the blood samples on day 4 and day 5 on both trial arms

• Plasma Volume

  Measured from the blood samples on day 4 and day 5 on both trial arms

• Other Metabolites

  Collected from the blood samples throughout day 5 of both trial arms

Study Arms (2)

Hypohydrated

EXPERIMENTAL

After being dehydrated in the heat tent, participants in this trial arm will be given 3 mL/kg lean body mass to consume over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass would consume 191 mL water \[63.75 kg \* 3 mL\])

Behavioral: Hypohydrated

Rehydrated

EXPERIMENTAL

After being dehydrated in the heat tent, participants in this trial arm will be given 40 mL/kg lean body mass plus 150 % of their water losses (from the heat tent procedure) over the rest of the day (e.g. a 75 kg participant with a body composition of 85 % fat free mass and lost 1 % of their body mass in the heat tent (0.75 kg) would consume 2550 mL \[63.75 kg \* 40 mL\] + 1125 mL \[750 g \* 1.5\], totalling 3675 mL).

Behavioral: Rehydrated

Interventions

Hypohydrated BEHAVIORAL

Participants remain hypohydrated after the heat tent procedure

Hypohydrated

Rehydrated BEHAVIORAL

Participants rehydrate after the heat tent procedure

Rehydrated

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female
• Aged 18-60 years
• Able and willing to give informed consent

You may not qualify if:

• Any known metabolic or glucose disorder
• Taking necessary medication (other than contraceptives) or supplements that are known to affect glycaemic control (e.g. chromium, PUFAs)
• Current alcohol or drug dependency
• Aged \< 18 years, or \> 60 years; pregnant or breastfeeding
• Any other factors which are deemed to have the potential to cause harm to the participant and/or could introduce bias into the study

Sponsors & Collaborators

• University of Bath: lead
• University of Bristol: collaborator
• Loughborough University: collaborator
• European Hydration Institute: collaborator
• Economic and Social Research Council, United Kingdom: collaborator
• Lund University: collaborator

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (4)

• Taveau C, Chollet C, Waeckel L, Desposito D, Bichet DG, Arthus MF, Magnan C, Philippe E, Paradis V, Foufelle F, Hainault I, Enhorning S, Velho G, Roussel R, Bankir L, Melander O, Bouby N. Vasopressin and hydration play a major role in the development of glucose intolerance and hepatic steatosis in obese rats. Diabetologia. 2015 May;58(5):1081-90. doi: 10.1007/s00125-015-3496-9. Epub 2015 Jan 27.

  PMID: 25622862 BACKGROUND

• Roussel R, Fezeu L, Bouby N, Balkau B, Lantieri O, Alhenc-Gelas F, Marre M, Bankir L; D.E.S.I.R. Study Group. Low water intake and risk for new-onset hyperglycemia. Diabetes Care. 2011 Dec;34(12):2551-4. doi: 10.2337/dc11-0652. Epub 2011 Oct 12.

  PMID: 21994426 BACKGROUND

• Keller U, Szinnai G, Bilz S, Berneis K. Effects of changes in hydration on protein, glucose and lipid metabolism in man: impact on health. Eur J Clin Nutr. 2003 Dec;57 Suppl 2:S69-74. doi: 10.1038/sj.ejcn.1601904.

  PMID: 14681716 BACKGROUND

• Zerbe RL, Vinicor F, Robertson GL. Plasma vasopressin in uncontrolled diabetes mellitus. Diabetes. 1979 May;28(5):503-8. doi: 10.2337/diab.28.5.503.

  PMID: 108167 BACKGROUND

Results Point of Contact

• Title: Dr Harriet Carroll
• Organization: University of Bath

hac38@bath.ac.uk

+447706548573

Study Officials

• Harriet A Carroll, MRes

  University of Bath

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 22, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 22, 2020
• Results First Posted: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available (no time restrictions)
• Access Criteria: Open access; doi URL below for hydration-glycaemia data, related report: https://doi.org/10.1152/japplphysiol.00771.2018; data for hydration-appetite: https://doi.org/10.15125/BATH-00719 and related report: https://doi.org/10.1016/j.physbeh.2019.112725

Locations

GB (1)