NCT03731065

Brief Summary

The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 14, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

November 2, 2018

Last Update Submit

December 7, 2019

Conditions

Exercise

Outcome Measures

Primary Outcomes (1)

  • Peak exogenous carbohydrate oxidation rate

    Peak exogenous carbohydrate oxidation rate during 120 min of treadmill running. Measured using isotope ratio mass spectrometry and reported in grams per minute

    120 minutes

Secondary Outcomes (11)

  • Total carbohydrate oxidation

    120 minutes

  • Ratings of gastrointestinal discomfort

    120 minutes

  • Total fat oxidation

    120 minutes

  • Plasma insulin concentrations

    120 minutes

  • Plasma glucose concentrations

    120 minutes

  • +6 more secondary outcomes

Study Arms (3)

Fructose-maltodextrin ingestion

ACTIVE COMPARATOR

Ingestion of fructose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.

Dietary Supplement: Fructose-maltodextrin

Fructose-maltodextrin hydrogel ingestion

EXPERIMENTAL

Ingestion of fructose and maltodextrin (glucose polymers) encapsulated in alginate-pectin hydrogel, drinks at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.

Dietary Supplement: Fructose-maltodextrin hydrogel

Glucose-maltodextrin ingestion

ACTIVE COMPARATOR

Ingestion of glucose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.

Dietary Supplement: Glucose-maltodextrin

Interventions

Fructose-maltodextrinDIETARY_SUPPLEMENT

Fructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.

Fructose-maltodextrin ingestion
Fructose-maltodextrin hydrogelDIETARY_SUPPLEMENT

Fructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.

Fructose-maltodextrin hydrogel ingestion
Glucose-maltodextrinDIETARY_SUPPLEMENT

Glucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.

Glucose-maltodextrin ingestion

Eligibility Criteria

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

You may qualify if:

  • Maximal oxygen consumption \> 50 ml.kg-1.min-1
  • \> 1 year training in endurance running or triathlon
  • No current injury or injury within the last three months
  • No history of cardiac or metabolic disease such as coronary heart disease or diabetes
  • No current or history of gastrointestinal issues
  • Successful completion of the physical activity readiness questionnaire (PAR-Q)

You may not qualify if:

  • Female
  • Untrained in endurance running
  • Current injury or injury within the past three months
  • History of cardiac or metabolic disease such as coronary heart disease or diabetes
  • History of or current gastrointestinal issues such as irritable bowel syndrome
  • Unable to replicate diet and training for 3 and 5 days respectively prior to each experimental visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 6, 2018

Study Start

October 14, 2018

Primary Completion

October 30, 2019

Study Completion

November 30, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

GB(1)