- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01246492
The Effect of Artificial Sweeteners on Blood Glucose Response
May 17, 2012 updated by: Northumbria University
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Sweet taste receptors, similar to those located on the lingual taste buds have been located along in the lining of the gut.
Recent studies have demonstrated that activation of these sweetness taste receptors, either by sugars such as glucose, fructose, lactose, or artificial sweeteners such as saccharin and aspartame can influence the way nutrients, including glucose are absorbed from the gut into the bloodstream.
Studies in animal models have shown that activation of the sweet taste receptors can increase the expression of the sodium-dependant glucose transporter 1 (SGLT1) and glucose transporter 2 (GLUT2) which transport glucose from the lumen into the bloodstream.
Thus providing a potential mechanism by which glucose uptake can be regulated.
Although artificial sweeteners stimulate the sweet taste receptors, they have little nutritive value, so that when they are consumed in the absence of any other nutrients there is little effect on blood glucose response.
However, the effects of consuming artificial sweeteners in combination with sugars such as glucose is unclear.
The purpose of this study is to investigate whether the addition of artificial sweeteners to an orally consumed glucose solution affects the rate at which the glucose appears in the blood.
Study Type
Interventional
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
-
-
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Newcastle-Upon Tyne, United Kingdom, NE1 8ST
- Brain, Performance and Nutrition Research Centre- Northumbria University
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-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
- Aged 18-45 years
- BMI (19-25 kg/m2)
- Weight stable in past 3 months
Exclusion Criteria:
- Smoking
- Females who are pregnant of breastfeeding
- Regular intake of emdication, other than females taking oral contraceptives
- Medical illness
- Gastrointestinal disorders
- Food allergies
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 45g glucose
glucose water
|
A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
|
Active Comparator: 45g glucose + 150mg aspartame
glucose water aspartame
|
A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
|
Active Comparator: 45g glucose + 20 mg saccharin
glucose water saccharin
|
A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
|
Active Comparator: 45g glucose + 85mg asculfame - K
glucose water aseulfame- k
|
A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose response
Time Frame: 90 min
|
Blood glucose will be determined at baseline and for 90 min following the consumption of the test drinks
|
90 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite
Time Frame: 90 min
|
Subjective appetite ratings will be collected at baseline and for 90 min following the consumption of the test drinks
|
90 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nerys M Astbury, PhD, Northumbria University
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
November 1, 2010
Primary Completion (Anticipated)
May 1, 2011
Study Completion (Anticipated)
May 1, 2011
Study Registration Dates
First Submitted
November 22, 2010
First Submitted That Met QC Criteria
November 22, 2010
First Posted (Estimate)
November 23, 2010
Study Record Updates
Last Update Posted (Estimate)
May 18, 2012
Last Update Submitted That Met QC Criteria
May 17, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 34AK1
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.
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