NCT03304197

Brief Summary

This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 11, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

September 13, 2017

Last Update Submit

October 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Absorption of fluid through the gut

    Absorption of drinks through the gut will be measured using 2 boluses of deuterated water. This will be consumed alongside 2 of the drinks, and blood samples will be used to quantify enrichment. Total body water calculations are required to provide corrections in equations related to D2O. H218O will be consumed in order to quantify total body water: this will be provided in a single bolus before each trial.

    To begin 10 minutes after the completion of the 90 minute steady-state cycle

Secondary Outcomes (1)

  • Work done (kJ) during 15 minute cycling time-trial

    Throughout the 90 minute steady-state cycle & the 15 minute time trial.

Other Outcomes (5)

  • Substrate utilisation

    Throughout the 90 minute steady-state cycle

  • Plasma metabolites

    Throughout the 90 minute steady-state cycle and time-trial

  • Heart rate

    Throughout the 90 minute steady-state cycle and time-trial

  • +2 more other outcomes

Study Arms (4)

Dehydrated

EXPERIMENTAL

90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test

Other: Dehydrated

Hypotonic

EXPERIMENTAL

90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g sucrose, 3g glucose) drinks, followed by a 15 minute cycling time trial test

Dietary Supplement: Hypotonic

Isotonic

EXPERIMENTAL

90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g glucose, 3g fructose) drinks, followed by a 15 minute cycling time trial test

Dietary Supplement: Isotonic

Placebo

EXPERIMENTAL

90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test

Dietary Supplement: Placebo

Interventions

HypotonicDIETARY_SUPPLEMENT

N/A: see arm description

Hypotonic
IsotonicDIETARY_SUPPLEMENT

N/A: see arm description

Isotonic
PlaceboDIETARY_SUPPLEMENT

N/A: see arm description

Placebo

N/A: see arm description

Dehydrated

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Highly trained cyclists (vo2max \>55 ml/kg/min, PPO (peak power output) \> 4 w/kg)
  • Training at least 4 times a week
  • Females must be taking an oral contraceptive, or using the contraceptive implant

You may not qualify if:

  • Recent history of musculoskeletal injury
  • Diagnosed cardiovascular disease
  • Regular use of nutritional supplements that may interfere with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports and Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Officials

  • Andrew D Davenport, MSc

    The University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Doubly-blinded \& randomised using an online randomisation website.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

October 6, 2017

Study Start

September 11, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations