NCT02075333

Brief Summary

The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

February 26, 2014

Last Update Submit

May 11, 2016

Conditions

Self-controlCognitive PerformanceBlood Glucose Response

Outcome Measures

Primary Outcomes (1)

  • Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions

    Change from baseline in capillary blood glucose (assessed by lancet fingerprick and YSI blood glucose analyser)

    - 30, -15, - 5, + 5, + 10, + 20, + 30, + 40 minutes relative to rinsing or ingestion of sucrose or sucralose solutions (each separated by 7 days in crossover manner)

Secondary Outcomes (3)

  • Visual verbal learning and memory performance following self-control depletion

    + 35 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)

  • Attention switching performance following self-control depletion

    + 20 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)

  • Continuous blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions

    24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)

Study Arms (2)

Sucrose (50g)

ACTIVE COMPARATOR

A 381g blackcurrant drink (cordial and water) providing 50g of sucrose

Dietary Supplement: Ingestion of solutionDietary Supplement: Rinising of solution

Sucralose (0.92 g sugars)

PLACEBO COMPARATOR

A 381g blackcurrant drink (cordial and water) providing 0.92g of natural sugars

Dietary Supplement: Ingestion of solutionDietary Supplement: Rinising of solution

Interventions

Ingestion of solutionDIETARY_SUPPLEMENT

Participants will ingest the solution

Sucralose (0.92 g sugars)Sucrose (50g)
Rinising of solutionDIETARY_SUPPLEMENT

Participants rinse the solution in the oral cavity

Sucralose (0.92 g sugars)Sucrose (50g)

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18 - 29 kg/m2

You may not qualify if:

  • Dementia
  • Depression
  • Type 2 diabetes
  • Phenylketonuria
  • Intake of medication known to affect glucose metabolism
  • Fasting blood glucose \> 7.8 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Appetite Research Unit (University of Leeds)

Leeds, LS29JT, United Kingdom

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Neil B Boyle

    University of Leeds

    PRINCIPAL INVESTIGATOR

  • Louise Dye

    University of Leeds

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Nutrition and Behaviour

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

GB(1)