Taste ReceptorsNCT01246492
The Effect of Artificial Sweeteners on Blood Glucose Response
A study testing Artificial Sweeteners in people with Taste Receptors and Nutrient Sensing, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Taste Receptors, Nutrient Sensing, Intestinal Absorption
- What is being tested?
- Artificial Sweeteners
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Aged 18-45 years
- BMI (19-25 kg/m2)
- Weight stable in past 3 months
Who cannot join
- Smoking
- Females who are pregnant of breastfeeding
- Regular intake of emdication, other than females taking oral contraceptives
- Medical illness
- Gastrointestinal disorders
- Food allergies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre- Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
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.
Read the 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.
- Being tested
- Artificial Sweeteners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial SweetenersDietary supplement
A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
| Study group | Role | What they receive |
|---|---|---|
| 45g glucose | Placebo comparator | glucose water Receives: Dietary Supplement: Artificial Sweeteners |
| 45g glucose + 150mg aspartame | Active comparator | glucose water aspartame Receives: Dietary Supplement: Artificial Sweeteners |
| 45g glucose + 20 mg saccharin | Active comparator | glucose water saccharin Receives: Dietary Supplement: Artificial Sweeteners |
| 45g glucose + 85mg asculfame - K | Active comparator | glucose water aseulfame- k Receives: Dietary Supplement: Artificial Sweeteners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response
Blood glucose will be determined at baseline and for 90 min following the consumption of the test drinks
Measured: 90 min
Secondary outcomes (1)
Subjective appetite
Subjective appetite ratings will be collected at baseline and for 90 min following the consumption of the test drinks
Measured: 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste ReceptorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Investigators
- Nerys M Astbury, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246492
- Sponsor's protocol ID
- 34AK1
- Status last verified
- May 2012
- First submitted
- 22 Nov 2010
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Sweeteners on Blood Glucose Response
- ClinicalTrials.gov ID
- NCT01246492
- Acronym / sponsor ID
- 34AK1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 45g glucose | Placebo comparator | Dietary Supplement: Artificial Sweetenersglucose water |
| 45g glucose + 150mg aspartame | Active comparator | Dietary Supplement: Artificial Sweetenersglucose water aspartame |
| 45g glucose + 20 mg saccharin | Active comparator | Dietary Supplement: Artificial Sweetenersglucose water saccharin |
| 45g glucose + 85mg asculfame - K | Active comparator | Dietary Supplement: Artificial Sweetenersglucose water aseulfame- k |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Aged 18-45 years
- BMI (19-25 kg/m2)
- Weight stable in past 3 months
Key exclusion criteria (6 listed)
- Smoking
- Females who are pregnant of breastfeeding
- Regular intake of emdication, other than females taking oral contraceptives
- Medical illness
- Gastrointestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial SweetenersA 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally | Dietary supplement | 45g glucose, 45g glucose + 150mg aspartame, 45g glucose + 20 mg saccharin, 45g glucose + 85mg asculfame - K |
Primary outcome
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
1 secondary outcome
Subjective appetite
Time frame: 90 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nerys M Astbury, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Sweeteners in people with Taste Receptors and Nutrient Sensing, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response (time frame: 90 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.