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

Cognitive Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075333
• Other study ID #: SN - 0114
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: May 11, 2016
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: May 2016
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Glucose Response
• Cognitive Performance
• Self-control

Intervention

Dietary Supplement:
• Ingestion of solution
Participants will ingest the solution
• Rinising of solution
Participants rinse the solution in the oral cavity

Locations

Country	Name	City	State
United Kingdom	Human Appetite Research Unit (University of Leeds)	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Sugar Nutrition, UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Visual verbal learning and memory performance following self-control depletion	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)	No
Secondary	Attention switching performance following self-control depletion	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)	No
Secondary	Continuous blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions	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)	No