Healthy VolunteersPhase 1/2NCT01200940
Metabolic Effects of Non-Nutritive Sweeteners
A Phase 1/2 study testing Sucralose, Aspartame and Acesulfame-Potassium in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may affect hormones in the body, especially when they are consumed in combination with real sugar. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sucralose, Aspartame and Acesulfame-Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2010to 30 Mar 2017
- Phase
- Phase 1/2
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- No known active medical conditions
- Age 6-12 years at enrollment
- Body weight at least 17 kg
- Prepubertal (Tanner stage I breasts in girls, or testicular volumes less than or equal to 3 mL in boys)
- No known active medical conditions
Who cannot join
- Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Positive urine pregnancy test
- Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures
Show all 17Show fewer
- Body weight less than 50 kg
- Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on oral glucose tolerance testing)
- Glycosuria
- PEDIATRIC PILOT STUDY:
- Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications and vitamins. Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide assent, and/or the subject s parent/guardian to provide informed consent, or to comply with study procedures
- Abnormal glucose tolerance (fasting blood glucose of 100 mg/dl or higher, or 2-hour blood glucose of 140 or higher on oral glucose tolerance testing)
- Glycosuria
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may affect hormones in the body, especially when they are consumed in combination with real sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite, and weight. Researchers are interested in studying the effects of artificial sweeteners on the metabolism and hormonal levels of healthy volunteers.
Read more
Objectives:
- To study the effects that artificial sweeteners have on hormone levels, blood sugar, and appetite.
- To evaluate whether artificial sweeteners change the rate at which food passes out of the stomach into the gut, or the rate at which the body absorbs sugar from the gut.
- To evaluate the effects that different amounts of artificial sweeteners have on hormone levels.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
- This study will require one screening visit and four testing visits, scheduled on different days.
- At the screening visit, eligible participants will be screened with a physical examination, medical history, blood samples, and body measurements (including height, weight, body circumferences, and skin folds). Participants will also be asked about how much artificial sweetener they typically consume and will have taste tests, in which a small amount of flavored liquid is placed on the tongue and participants will name the flavor and rate its intensity.
- Participants will have four glucose tolerance tests on four different days. In preparation for the test, participants will not eat or drink anything but water for 12 hours prior to the test. Blood will be drawn before the test, and participants will drink one of the following study liquids, selected at random:
- Plain water
- Water mixed with sucralose (the amount found in one 12 oz diet soft drink)
- Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)
- Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)
- Ten minutes after drinking the study liquid, participants will have a sugary drink that will allow researchers to measure sugar absorption and the speed with which food leaves the stomach.
- In addition, participants will complete questionnaires about hunger levels before drinking the sugar solution and at regular intervals for 2 hours afterward. Blood samples will be taken at regular intervals as well.
Read the detailed description
Background
Consumption of non-nutritive sweeteners is common practice in the US, and these chemicals are generally thought to be metabolically inert. However, recent data obtained from animal studies demonstrate that non-nutritive sweeteners play an active metabolic role within the gastrointestinal tract. Sweet-taste receptors, including the T1R family and Alpha-gustducin, respond not only to caloric sugars such as sucrose, but also to non-nutritive sweeteners, including sucralose (Splenda ) and acesulfame-K . In both humans and animals, these receptors have been shown to be present in glucagon-like-peptide-1 (GLP-1) secreting L cells of the gut mucosa as well as in lingual taste buds , and serve as critical mediators of GLP-1 secretion . We have demonstrated in a previous study that diet soda augments glucose-stimulated GLP-1 secretion . In addition, there is evidence in animals that activation of intestinal sweet-taste receptors by non-nutritive sweeteners enhances intestinal glucose absorption via upregulation of the glucose transporter, GLUT2 .
Aims
The purpose of this study is to broadly explore the effects of non-nutritive sweeteners on glucose and glucoregulatory hormones in healthy humans. To this end, we plan the following:
Primary Aim: To confirm that the non-nutritive sweetener sucralose (versus other ingredients in diet soda) augments glucose-stimulated GLP-1 secretion
Secondary Aims:
- To study whether increased GLP-1 secretion due to non-nutritive sweeteners alters gastric emptying or satiety
- To determine a dose-response relationship for non-nutritive sweeteners on glucose-stimulated GLP-1 secretion
- To determine whether non-nutritive sweeteners alter the rate of intestinal glucose absorption
- To test whether non-nutritive sweeteners affect levels of other incretin or gut hormones
Methods
Healthy men and women ages greater than or equal to 18 years, and prepubertal children ages 6-12 years, across a wide range of body mass indices will participate in a variety of paired experiments, in randomized order, with each subject serving as his or her own control. In each experiment, the subject will ingest either a non-nutritive sweetener or control, and a glucose load (oral glucose tolerance test). The following measurements will be obtained:
- Serial measurement of glucose, insulin, C-peptide, GLP-1, and other incretin and gut hormones
- Rate of gastric emptying using acetaminophen labeling in the oral glucose or mixed meal
- Measurement of hunger and satiety using validated questionnaires
- Measurement of intestinal glucose absorption using a glucose analog
- Conditions
- Healthy Volunteers
- Being tested
- Sucralose, Aspartame, Acesulfame-Potassium, Control
- Keywords
- GLP-1, Glucose Tolerance, Gut Hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseOther
sucralose will be given at doses of 68 mg (equivalent to one 12 oz soda) 170 mg (equivalent to two and one-half 12 oz sodas, and 250 mg (equal to 100% of the FDA s acceptable daily intake for a 50kg individual).
AspartameOther
To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .
Acesulfame-PotassiumOther
To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .
ControlOther
360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Low-dose sweetener | Experimental | 68 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Sucralose |
| Phase I - Medium-dose sweetener | Experimental | 170 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Sucralose |
| Phase I Control Condition | Placebo comparator | 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Control |
| Phase I- High-dose sweetener | Experimental | 250 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test. Receives: Other: Sucralose |
| Phase II - Control Condition | Placebo comparator | 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Control |
| Phase II - Diet Soda 1 | Experimental | less than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Sucralose; Other: Acesulfame-Potassium |
| Phase II - Diet Soda 2 | Experimental | less than or equal to 5 mg/kg sucralose, less than or equal to 50 mg/kg aspartame, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Sucralose; Other: Aspartame; Other: Acesulfame-Potassium |
| Phase II - Water with sucralose and acesulfame-potassium | Experimental | less than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test Receives: Other: Sucralose; Other: Acesulfame-Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 secretion change with sucralose
After a 10-hour fast, subjects will drink a 75-gram oral glucose solution. Samples will be drawn at -10, 0, 10, 20, 30, 60, 90, and 120 minutes.
Measured: At minute -10,0,10, 20,30,60,90,120
Secondary outcomes (2)
Change in gastric emptying
Gastric emptying will be assessed using acetaminophen labeling. For this test, 1450 mg of acetaminophen oral solution (14.5 mL of acetaminophen infant drops, 100 mg/mL) will be mixed with the oral glucose solution or mixed meal. Acetaminophen levels will be measured at the same time points as the primary outcome.
Measured: At minute -10,0,10, 20,30,60,90,120
Change in satiety
Perceived ratings of hunger and satiety will be measured through the use of questionnaires during the OGTT or mixed meal tests. Starting 10 minutes before consumption of the non- nutritive sweetener/placebo, the subject with fill out a Visual Analogue Scale (VAS) which contains questions on hunger and satiety. The VAS will be filled out at -10,0,30, 60, 90, and 120 minutes.
Measured: At minute -10,0,10, 20,30,60,90,120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start4 Nov 2010
- Primary completion2 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rebecca J Brown, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200940
- Sponsor's protocol ID
- 100163
- Other IDs
- 10-DK-0163
- Status last verified
- Jan 2021
- First submitted
- 11 Sep 2010
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. doi: 10.1186/s12986-016-0129-3. eCollection 2016.
PubMed 27777606
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Non-Nutritive Sweeteners
- ClinicalTrials.gov ID
- NCT01200940
- Acronym / sponsor ID
- 100163
- Conditions
- Healthy Volunteers
- Keywords
- GLP-1, Glucose Tolerance, Gut Hormones
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 4 Nov 2010 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 14 Sep 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.
Background:
- Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may affect hormones in the body, especially when they are consumed in combination with real sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite, and weight. Researchers are interested in studying the effects of artificial sweeteners on the metabolism and hormonal levels of healthy volunteers.
Objectives:
- To study the effects that artificial sweeteners have on hormone levels, blood sugar, and appetite.
- To evaluate whether artificial sweeteners change the rate at which food passes out of the stomach into the gut, or the rate at which the body absorbs sugar from the gut.
- To evaluate the effects that different amounts of artificial sweeteners have on hormone levels.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
- This study will require one screening visit and four testing visits, scheduled on different days.
- At the screening visit, eligible participants will be screened with a physical examination, medical history, blood samples, and body measurements (including height, weight, body circumferences, and skin folds). Participants will also be asked about how much artificial sweetener they typically consume and will have taste tests, in which a small amount of flavored liquid is placed on the tongue and participants will name the flavor and rate its intensity.
- Participants will have four glucose tolerance tests on four different days. In preparation for the test, participants will not eat or drink anything but water for 12 hours prior to the test. Blood will be drawn before the test, and participants will drink one of the following study liquids, selected at random:
- Plain water
- Water mixed with sucralose (the amount found in one 12 oz diet soft drink)
- Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)
- Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)
- Ten minutes after drinking the study liquid, participants will have a sugary drink that will allow researchers to measure sugar absorption and the speed with which food leaves the stomach.
- In addition, participants will complete questionnaires about hunger levels before drinking the sugar solution and at regular intervals for 2 hours afterward. Blood samples will be taken at regular intervals as well.
Detailed description
Background
Consumption of non-nutritive sweeteners is common practice in the US, and these chemicals are generally thought to be metabolically inert. However, recent data obtained from animal studies demonstrate that non-nutritive sweeteners play an active metabolic role within the gastrointestinal tract. Sweet-taste receptors, including the T1R family and Alpha-gustducin, respond not only to caloric sugars such as sucrose, but also to non-nutritive sweeteners, including sucralose (Splenda ) and acesulfame-K . In both humans and animals, these receptors have been shown to be present in glucagon-like-peptide-1 (GLP-1) secreting L cells of the gut mucosa as well as in lingual taste buds , and serve as critical mediators of GLP-1 secretion . We have demonstrated in a previous study that diet soda augments glucose-stimulated GLP-1 secretion . In addition, there is evidence in animals that activation of intestinal sweet-taste receptors by non-nutritive sweeteners enhances intestinal glucose absorption via upregulation of the glucose transporter, GLUT2 .
Aims
The purpose of this study is to broadly explore the effects of non-nutritive sweeteners on glucose and glucoregulatory hormones in healthy humans. To this end, we plan the following:
Primary Aim: To confirm that the non-nutritive sweetener sucralose (versus other ingredients in diet soda) augments glucose-stimulated GLP-1 secretion
Secondary Aims:
- To study whether increased GLP-1 secretion due to non-nutritive sweeteners alters gastric emptying or satiety
- To determine a dose-response relationship for non-nutritive sweeteners on glucose-stimulated GLP-1 secretion
- To determine whether non-nutritive sweeteners alter the rate of intestinal glucose absorption
- To test whether non-nutritive sweeteners affect levels of other incretin or gut hormones
Methods
Healthy men and women ages greater than or equal to 18 years, and prepubertal children ages 6-12 years, across a wide range of body mass indices will participate in a variety of paired experiments, in randomized order, with each subject serving as his or her own control. In each experiment, the subject will ingest either a non-nutritive sweetener or control, and a glucose load (oral glucose tolerance test). The following measurements will be obtained:
- Serial measurement of glucose, insulin, C-peptide, GLP-1, and other incretin and gut hormones
- Rate of gastric emptying using acetaminophen labeling in the oral glucose or mixed meal
- Measurement of hunger and satiety using validated questionnaires
- Measurement of intestinal glucose absorption using a glucose analog
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase I - Low-dose sweetener | Experimental | Other: Sucralose68 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase I - Medium-dose sweetener | Experimental | Other: Sucralose170 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase I Control Condition | Placebo comparator | Other: Control360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase I- High-dose sweetener | Experimental | Other: Sucralose250 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test. |
| Phase II - Control Condition | Placebo comparator | Other: Control360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase II - Diet Soda 1 | Experimental | Other: Sucralose, Other: Acesulfame-Potassiumless than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase II - Diet Soda 2 | Experimental | Other: Sucralose, Other: Aspartame, Other: Acesulfame-Potassiumless than or equal to 5 mg/kg sucralose, less than or equal to 50 mg/kg aspartame, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
| Phase II - Water with sucralose and acesulfame-potassium | Experimental | Other: Sucralose, Other: Acesulfame-Potassiumless than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- No known active medical conditions
- Age 6-12 years at enrollment
- Body weight at least 17 kg
- Prepubertal (Tanner stage I breasts in girls, or testicular volumes less than or equal to 3 mL in boys)
Key exclusion criteria (17 listed)
- Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
- Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
- ALT or AST more than 1.5 times the upper limit of normal
- Positive urine pregnancy test
- Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
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 |
|---|---|---|
| Sucralosesucralose will be given at doses of 68 mg (equivalent to one 12 oz soda) 170 mg (equivalent to two and one-half 12 oz sodas, and 250 mg (equal to 100% of the FDA s acceptable daily intake for a 50kg individual). | Other | Phase I - Low-dose sweetener, Phase I - Medium-dose sweetener, Phase I- High-dose sweetener, Phase II - Diet Soda 1, Phase II - Diet Soda 2, Phase II - Water with sucralose and acesulfame-potassium |
| AspartameTo determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola . | Other | Phase II - Diet Soda 2 |
| Acesulfame-PotassiumTo determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola . | Other | Phase II - Diet Soda 1, Phase II - Diet Soda 2, Phase II - Water with sucralose and acesulfame-potassium |
| Control360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test | Other | Phase I Control Condition, Phase II - Control Condition |
Primary outcome
GLP-1 secretion change with sucralose
Time frame: At minute -10,0,10, 20,30,60,90,120
After a 10-hour fast, subjects will drink a 75-gram oral glucose solution. Samples will be drawn at -10, 0, 10, 20, 30, 60, 90, and 120 minutes.
2 secondary outcomes
Change in gastric emptying
Time frame: At minute -10,0,10, 20,30,60,90,120
Change in satiety
Time frame: At minute -10,0,10, 20,30,60,90,120
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 22 Jan 2021.
- Derived from this study: PubMed 27777606Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. doi: 10.1186/s12986-016-0129-3. eCollection 2016.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Rebecca J Brown, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sucralose, Aspartame and Acesulfame-Potassium in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 6 inclusion and 17 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 22 Jan 2021. 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 States. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
GLP-1 secretion change with sucralose (time frame: At minute -10,0,10, 20,30,60,90,120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200940, which also lists 1 linked publication.
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 22 Jan 2021.