HealthyPhase 1NCT00978900
Effects of Artificial Sweetener on Gastrointestinal (GI) Peptide Secretion
A Phase 1 study testing Artificial sweeteners; Carbohydrate Sugars and Water in people with Healthy, run by University Hospital, Basel, Switzerland.
Trial summary
The purpose of this study is to examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Artificial sweeteners; Carbohydrate Sugars and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jul 2009
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject with a body-mass index of 19.0-24.5
- Normal eating habits
- Age 18-40 years
- Stable body weight for at least three months
Who cannot join
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- history of gastrointestinal disorders
- food allergies
About this study
Official title: Carbohydrates and Non Caloric Sweeteners: Differential Effects on Appetite and Secretion of Gastrointestinal Satiety Peptide
The purpose of this study is to examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans.
Read the detailed description
Artificial Sweeteners significantly lower energy density of foods and beverages. They are used by diabetics as sugar substitutes as well as by consumers as aids for dietary control. Despite numerous studies which show mainly no influence of artificial sweeteners on glucose metabolism and food intake, discrepancies consist about the real effects of artificial sweeteners. Studies by Blundell and Hill in 1986 have however shown that the consumption of artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has therefore been questioned. With respect to the world wide increase in the prevalence in obesity, it seems important to clarify whether artificial sweeteners can help regulate body weight or not. This study will explore the effect of artificial sweeteners on the release of the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial sweeteners; Carbohydrate SugarsDietary supplement
sweetening agent dissolved in tap water, administered via intragastric tube
WaterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Acesulfame K | Active comparator | Not described Receives: Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Sucralose | Active comparator | Not described Receives: Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Aspartame | Active comparator | Not described Receives: Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Glucose | Active comparator | Not described Receives: Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Fructose | Active comparator | Not described Receives: Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Water | Placebo comparator | Not described Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal peptide secretion
Measured: 2 hour blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Beglinger, MD, Principal investigator, Clinical Research Center, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978900
- Sponsor's protocol ID
- EKBB 69/04
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2009
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrates and Non Caloric Sweeteners: Differential Effects on Appetite and Secretion of Gastrointestinal Satiety Peptide
- ClinicalTrials.gov ID
- NCT00978900
- Acronym / sponsor ID
- EKBB 69/04
- Conditions
- Healthy
- Keywords
- satiety peptides, GLP-1, PYY, ghrelin, appetite profile, Sweetening Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Sep 2009 (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 examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans.
Detailed description
Artificial Sweeteners significantly lower energy density of foods and beverages. They are used by diabetics as sugar substitutes as well as by consumers as aids for dietary control. Despite numerous studies which show mainly no influence of artificial sweeteners on glucose metabolism and food intake, discrepancies consist about the real effects of artificial sweeteners. Studies by Blundell and Hill in 1986 have however shown that the consumption of artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has therefore been questioned. With respect to the world wide increase in the prevalence in obesity, it seems important to clarify whether artificial sweeteners can help regulate body weight or not. This study will explore the effect of artificial sweeteners on the release of the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acesulfame K | Active comparator | Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Sucralose | Active comparator | Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Aspartame | Active comparator | Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Glucose | Active comparator | Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Fructose | Active comparator | Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars |
| Water | Placebo comparator | Dietary Supplement: Water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subject with a body-mass index of 19.0-24.5
- Normal eating habits
- Age 18-40 years
- Stable body weight for at least three months
Key exclusion criteria (6 listed)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- history of 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 sweeteners; Carbohydrate Sugarssweetening agent dissolved in tap water, administered via intragastric tube | Dietary supplement | Acesulfame K, Aspartame, Fructose, Glucose, Sucralose |
| Water | Dietary supplement | Water |
Primary outcome
Gastrointestinal peptide secretion
Time frame: 2 hour blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
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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.
Christoph Beglinger, MD principal investigator
Clinical Research Center, University Hospital Basel
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artificial sweeteners; Carbohydrate Sugars and Water in people with Healthy, run by University Hospital, Basel, Switzerland.
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: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastrointestinal peptide secretion (time frame: 2 hour blood sampling). 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 17 Sep 2009.