The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose

May 11, 2016 updated by: Prof Louise Dye, University of Leeds

The Effects of Ingesting or Rinsing Sucrose and Sucralose Solutions on Self-control, Cognitive Performance, and Blood Glucose Level

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leeds, United Kingdom, LS29JT
        • Human Appetite Research Unit (University of Leeds)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18 - 29 kg/m2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sucrose (50g)
A 381g blackcurrant drink (cordial and water) providing 50g of sucrose
Participants will ingest the solution
Participants rinse the solution in the oral cavity
PLACEBO_COMPARATOR: Sucralose (0.92 g sugars)
A 381g blackcurrant drink (cordial and water) providing 0.92g of natural sugars
Participants will ingest the solution
Participants rinse the solution in the oral cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions
Time Frame: - 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual verbal learning and memory performance following self-control depletion
Time Frame: + 35 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Visual verbal learning performance will be assessed by the Visual Verbal Learning Test (Rey, 1964) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution
+ 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
Time Frame: + 20 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)
Attention switching performance will be assessed by a switch task (Rogers and Monsell, 1995) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution
+ 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
Time Frame: 24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)
A subgroup of 10 participants recruited into the study will be fitted with a continuous glucose monitoring device (CGMS, iPRO) the day preceding each of the test days to measure continuous interstitial blood glucose levels
24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Neil B Boyle, University of Leeds
  • Study Chair: Louise Dye, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SN - 0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Performance

Clinical Trials on Ingestion of solution

3
Subscribe