NCT01246492

Brief Summary

The purpose of this study is to determine whether the presece of the artificial sweeteners aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally incested glucose solution.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

November 22, 2010

Last Update Submit

May 17, 2012

Conditions

Taste ReceptorsNutrient SensingIntestinal AbsorptionBlood GlucoseAppetite

Outcome Measures

Primary Outcomes (1)

  • Blood glucose response

    Blood glucose will be determined at baseline and for 90 min following the consumption of the test drinks

    90 min

Secondary Outcomes (1)

  • Subjective appetite

    90 min

Study Arms (4)

45g glucose

PLACEBO COMPARATOR

glucose water

Dietary Supplement: Artificial Sweeteners

45g glucose + 150mg aspartame

ACTIVE COMPARATOR

glucose water aspartame

Dietary Supplement: Artificial Sweeteners

45g glucose + 20 mg saccharin

ACTIVE COMPARATOR

glucose water saccharin

Dietary Supplement: Artificial Sweeteners

45g glucose + 85mg asculfame - K

ACTIVE COMPARATOR

glucose water aseulfame- k

Dietary Supplement: Artificial Sweeteners

Interventions

Artificial SweetenersDIETARY_SUPPLEMENT

A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally

45g glucose45g glucose + 150mg aspartame45g glucose + 20 mg saccharin45g glucose + 85mg asculfame - K

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Aged 18-45 years
  • BMI (19-25 kg/m2)
  • Weight stable in past 3 months

You may not qualify if:

  • Smoking
  • Females who are pregnant of breastfeeding
  • Regular intake of emdication, other than females taking oral contraceptives
  • Medical illness
  • Gastrointestinal disorders
  • Food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre- Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Sweetening Agents

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nerys M Astbury, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR
0

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

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 23, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

GB(1)