Insulin SensitivityNCT02890108
Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
A study testing Sugar sweetened beverages and Artificially sweetened beverages in people with Insulin Sensitivity, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
Trial summary
This study will compare the effect of acute consumption of two carbonated drinks, sweetened with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who normally consumed foods or drinks that contain non-caloric sweeteners Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Sugar sweetened beverages and Artificially sweetened beverages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- Aug 2016to Oct 2016
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 18,5 - 24,9 kg/mt2
- Healthy men or women
- Fasting plasma glucose < 100 mg/dL
Who cannot join
- Consumption of drugs affecting glucose metabolism, antihypertensives or lipid lowering
- Subjects with insulin resistance, type 1 or 2 diabetes, dyslipidemia, hypertension; heart, liver or kidney disease, respiratory failure, stroke, or any chronic illness.
- Pregnant women.
- Being treated to gain or lose weight.
- History of recurrent episodes of acute diarrhea.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Institute of Nutrition and Tecnology of Food, University of Chile
Santiago, Metropolitan Region
Verónica Cornejo Espinoza, Director, +56229781 410, vcornejo@inta.uchile.cl
Sandra Hirsch Birn, Academic, +56229781495 ext. +56229781499, shirsch@inta.uchile.cl
About this study
This study will compare the effect of acute consumption of two carbonated drinks, sweetened with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who normally consumed foods or drinks that contain non-caloric sweeteners
Read the detailed description
During the last decades there has been a sustained increase in prevalence of overweight and obesity and, along with it, of chronic noncommunicable diseases. There have been addressed various management strategies, including sugar replacement for Non-caloric Artificial Sweeteners (NAS). Nevertheless, in several cohort studies it has found the opposite effect, it has observed associations between the consumption of NAS with greater weight gain and increased risk of type 2 diabetes and metabolic syndrome. In clinical trials, in both humans and mice, there has been greater association with glucose intolerance, being 3 possible mechanisms: 1) dysbiosis of the intestinal microbiota; 2) altered regulation of appetite cephalic phase and secretion of glucagon like peptide-1 (GLP-1); and 3) increased intestinal glucose absorption via increased Sodium-Glucose Linked Transporter-1 (SGLT-1) and Glucose transporter 2 (GLUT2), transporters to glucose absorption.
In the following review the major findings in the literature regarding the consumption of NAS and its deleterious effects on human health will be studied.
- Conditions
- Insulin Sensitivity
- Being tested
- Sugar sweetened beverages, Artificially sweetened beverages
- Keywords
- High-Intensity Sweeteners, Non-Nutritive Sweeteners, Artificial sweeteners, Glucose intolerance
- Medical subject headings
- Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar sweetened beveragesDietary supplement
Also called Sugar sweetened drinks
350 cc (1 can) of sugar sweetened beverage
Artificially sweetened beveragesDietary supplement
Also called Artificially sweetened drinks
350 cc (1 can) of artificially sweetened beverage
| Study group | Role | What they receive |
|---|---|---|
| Sugar sweetened beverages | Experimental | Subjects will receive, in 3 different ocassions, 350cc (1 can) of a sugar sweetened beverage, that contain 38,7 grams of carbs and 154 kcal, separated by at least 1 week each one Receives: Dietary Supplement: Sugar sweetened beverages |
| Artificially sweetened beverage | Experimental | Subjects will receive, in 3 different ocassions, 350cc (1 can) of a artificially sweetened beverage, that contain 84 mg of Aspartame, 56 mg of Acesulfame K and 0,7 kcal, separated by at least 1 week each one Receives: Dietary Supplement: Artificially sweetened beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensibility
One insulinemic curve will be conducted to assess the effect of consumption of artificially sweetened beverage on insulin response compared to the consumption of a sugar sweetened drink.
Measured: Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.
Secondary outcomes (1)
Glycemic response
One glycemic curve will be conducted to assess the effect of consumption of artificially sweetened beverage on glycemic response compared to the consumption of a sugar sweetened drink.
Measured: Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Nutrición y Tecnología de los Alimentos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romina Goza Ferreira, Instituto de Nutrición y Tecnología de los Alimentos
- Investigators
- Romina A Goza Ferreira, Magister c, Principal investigator, Institute of Nutrition and Tecnology of Food, University of ChileSandra Hirsch Birn, Magister, Study director, Institute of Nutrition and Tecnology of Food, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890108
- Sponsor's protocol ID
- EANC-1
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All the data is confidential and only will be show if ethics committee ask for it
Publications
Pan A, Malik VS, Hao T, Willett WC, Mozaffarian D, Hu FB. Changes in water and beverage intake and long-term weight changes: results from three prospective cohort studies. Int J Obes (Lond). 2013 Oct;37(10):1378-85. doi: 10.1038/ijo.2012.225. Epub 2013 Jan 15.
PubMed 23318721de Koning L, Malik VS, Rimm EB, Willett WC, Hu FB. Sugar-sweetened and artificially sweetened beverage consumption and risk of type 2 diabetes in men. Am J Clin Nutr. 2011 Jun;93(6):1321-7. doi: 10.3945/ajcn.110.007922. Epub 2011 Mar 23.
PubMed 21430119Nettleton JA, Lutsey PL, Wang Y, Lima JA, Michos ED, Jacobs DR Jr. Diet soda intake and risk of incident metabolic syndrome and type 2 diabetes in the Multi-Ethnic Study of Atherosclerosis (MESA). Diabetes Care. 2009 Apr;32(4):688-94. doi: 10.2337/dc08-1799. Epub 2009 Jan 16.
PubMed 19151203Pepino MY. Metabolic effects of non-nutritive sweeteners. Physiol Behav. 2015 Dec 1;152(Pt B):450-5. doi: 10.1016/j.physbeh.2015.06.024. Epub 2015 Jun 19.
PubMed 26095119Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
PubMed 23850261Feijo FM, Ballard CR, Foletto KC, Batista BAM, Neves AM, Ribeiro MFM, Bertoluci MC. Saccharin and aspartame, compared with sucrose, induce greater weight gain in adult Wistar rats, at similar total caloric intake levels. Appetite. 2013 Jan;60(1):203-207. doi: 10.1016/j.appet.2012.10.009. Epub 2012 Oct 23.
PubMed 23088901Anton SD, Martin CK, Han H, Coulon S, Cefalu WT, Geiselman P, Williamson DA. Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. Appetite. 2010 Aug;55(1):37-43. doi: 10.1016/j.appet.2010.03.009. Epub 2010 Mar 18.
PubMed 20303371Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
PubMed 25231862Palmnas MS, Cowan TE, Bomhof MR, Su J, Reimer RA, Vogel HJ, Hittel DS, Shearer J. Low-dose aspartame consumption differentially affects gut microbiota-host metabolic interactions in the diet-induced obese rat. PLoS One. 2014 Oct 14;9(10):e109841. doi: 10.1371/journal.pone.0109841. eCollection 2014.
PubMed 25313461Brown RJ, Walter M, Rother KI. Ingestion of diet soda before a glucose load augments glucagon-like peptide-1 secretion. Diabetes Care. 2009 Dec;32(12):2184-6. doi: 10.2337/dc09-1185. Epub 2009 Oct 6.
PubMed 19808921Temizkan S, Deyneli O, Yasar M, Arpa M, Gunes M, Yazici D, Sirikci O, Haklar G, Imeryuz N, Yavuz DG. Sucralose enhances GLP-1 release and lowers blood glucose in the presence of carbohydrate in healthy subjects but not in patients with type 2 diabetes. Eur J Clin Nutr. 2015 Feb;69(2):162-6. doi: 10.1038/ejcn.2014.208. Epub 2014 Oct 1.
PubMed 25271009Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
PubMed 23633524
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
- ClinicalTrials.gov ID
- NCT02890108
- Acronym / sponsor ID
- EANC-1
- Conditions
- Insulin Sensitivity
- Keywords
- High-Intensity Sweeteners, Non-Nutritive Sweeteners, Artificial sweeteners, Glucose intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Nutrición y Tecnología de los AlimentosUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 7 Sep 2016 (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.
This study will compare the effect of acute consumption of two carbonated drinks, sweetened with sugar or with non-caloric sweeteners, over the insulin response of healthy adults who normally consumed foods or drinks that contain non-caloric sweeteners
Detailed description
During the last decades there has been a sustained increase in prevalence of overweight and obesity and, along with it, of chronic noncommunicable diseases. There have been addressed various management strategies, including sugar replacement for Non-caloric Artificial Sweeteners (NAS). Nevertheless, in several cohort studies it has found the opposite effect, it has observed associations between the consumption of NAS with greater weight gain and increased risk of type 2 diabetes and metabolic syndrome. In clinical trials, in both humans and mice, there has been greater association with glucose intolerance, being 3 possible mechanisms: 1) dysbiosis of the intestinal microbiota; 2) altered regulation of appetite cephalic phase and secretion of glucagon like peptide-1 (GLP-1); and 3) increased intestinal glucose absorption via increased Sodium-Glucose Linked Transporter-1 (SGLT-1) and Glucose transporter 2 (GLUT2), transporters to glucose absorption.
In the following review the major findings in the literature regarding the consumption of NAS and its deleterious effects on human health will be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar sweetened beverages | Experimental | Dietary Supplement: Sugar sweetened beveragesSubjects will receive, in 3 different ocassions, 350cc (1 can) of a sugar sweetened beverage, that contain 38,7 grams of carbs and 154 kcal, separated by at least 1 week each one |
| Artificially sweetened beverage | Experimental | Dietary Supplement: Artificially sweetened beveragesSubjects will receive, in 3 different ocassions, 350cc (1 can) of a artificially sweetened beverage, that contain 84 mg of Aspartame, 56 mg of Acesulfame K and 0,7 kcal, separated by at least 1 week each one |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 18,5 - 24,9 kg/mt2
- Healthy men or women
- Fasting plasma glucose < 100 mg/dL
Key exclusion criteria (5 listed)
- Consumption of drugs affecting glucose metabolism, antihypertensives or lipid lowering
- Subjects with insulin resistance, type 1 or 2 diabetes, dyslipidemia, hypertension; heart, liver or kidney disease, respiratory failure, stroke, or any chronic illness.
- Pregnant women.
- Being treated to gain or lose weight.
- History of recurrent episodes of acute diarrhea.
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 |
|---|---|---|
| Sugar sweetened beveragesAlso: Sugar sweetened drinks350 cc (1 can) of sugar sweetened beverage | Dietary supplement | Sugar sweetened beverages |
| Artificially sweetened beveragesAlso: Artificially sweetened drinks350 cc (1 can) of artificially sweetened beverage | Dietary supplement | Artificially sweetened beverage |
Primary outcome
Insulin sensibility
Time frame: Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.
One insulinemic curve will be conducted to assess the effect of consumption of artificially sweetened beverage on insulin response compared to the consumption of a sugar sweetened drink.
1 secondary outcome
Glycemic response
Time frame: Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 23318721Pan A, Malik VS, Hao T, Willett WC, Mozaffarian D, Hu FB. Changes in water and beverage intake and long-term weight changes: results from three prospective cohort studies. Int J Obes (Lond). 2013 Oct;37(10):1378-85. doi: 10.1038/ijo.2012.225. Epub 2013 Jan 15.
- Background: PubMed 21430119de Koning L, Malik VS, Rimm EB, Willett WC, Hu FB. Sugar-sweetened and artificially sweetened beverage consumption and risk of type 2 diabetes in men. Am J Clin Nutr. 2011 Jun;93(6):1321-7. doi: 10.3945/ajcn.110.007922. Epub 2011 Mar 23.
- Background: PubMed 19151203Nettleton JA, Lutsey PL, Wang Y, Lima JA, Michos ED, Jacobs DR Jr. Diet soda intake and risk of incident metabolic syndrome and type 2 diabetes in the Multi-Ethnic Study of Atherosclerosis (MESA). Diabetes Care. 2009 Apr;32(4):688-94. doi: 10.2337/dc08-1799. Epub 2009 Jan 16.
- Background: PubMed 26095119Pepino MY. Metabolic effects of non-nutritive sweeteners. Physiol Behav. 2015 Dec 1;152(Pt B):450-5. doi: 10.1016/j.physbeh.2015.06.024. Epub 2015 Jun 19.
- Background: PubMed 23850261Swithers SE. Artificial sweeteners produce the counterintuitive effect of inducing metabolic derangements. Trends Endocrinol Metab. 2013 Sep;24(9):431-41. doi: 10.1016/j.tem.2013.05.005. Epub 2013 Jul 10.
- Background: PubMed 23088901Feijo FM, Ballard CR, Foletto KC, Batista BAM, Neves AM, Ribeiro MFM, Bertoluci MC. Saccharin and aspartame, compared with sucrose, induce greater weight gain in adult Wistar rats, at similar total caloric intake levels. Appetite. 2013 Jan;60(1):203-207. doi: 10.1016/j.appet.2012.10.009. Epub 2012 Oct 23.
- Background: PubMed 20303371Anton SD, Martin CK, Han H, Coulon S, Cefalu WT, Geiselman P, Williamson DA. Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. Appetite. 2010 Aug;55(1):37-43. doi: 10.1016/j.appet.2010.03.009. Epub 2010 Mar 18.
- Background: PubMed 25231862Suez J, Korem T, Zeevi D, Zilberman-Schapira G, Thaiss CA, Maza O, Israeli D, Zmora N, Gilad S, Weinberger A, Kuperman Y, Harmelin A, Kolodkin-Gal I, Shapiro H, Halpern Z, Segal E, Elinav E. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17.
- Background: PubMed 25313461Palmnas MS, Cowan TE, Bomhof MR, Su J, Reimer RA, Vogel HJ, Hittel DS, Shearer J. Low-dose aspartame consumption differentially affects gut microbiota-host metabolic interactions in the diet-induced obese rat. PLoS One. 2014 Oct 14;9(10):e109841. doi: 10.1371/journal.pone.0109841. eCollection 2014.
- Background: PubMed 19808921Brown RJ, Walter M, Rother KI. Ingestion of diet soda before a glucose load augments glucagon-like peptide-1 secretion. Diabetes Care. 2009 Dec;32(12):2184-6. doi: 10.2337/dc09-1185. Epub 2009 Oct 6.
- Background: PubMed 25271009Temizkan S, Deyneli O, Yasar M, Arpa M, Gunes M, Yazici D, Sirikci O, Haklar G, Imeryuz N, Yavuz DG. Sucralose enhances GLP-1 release and lowers blood glucose in the presence of carbohydrate in healthy subjects but not in patients with type 2 diabetes. Eur J Clin Nutr. 2015 Feb;69(2):162-6. doi: 10.1038/ejcn.2014.208. Epub 2014 Oct 1.
- Background: PubMed 23633524Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.
- Individual participant dataSharing planned: No. All the data is confidential and only will be show if ethics committee ask for it
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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.
Romina A Goza Ferreira, Magister c principal investigator
Institute of Nutrition and Tecnology of Food, University of Chile
Sandra Hirsch Birn, Magister study director
Institute of Nutrition and Tecnology of Food, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar sweetened beverages and Artificially sweetened beverages in people with Insulin Sensitivity, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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 Chile. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romina A Goza Ferreira, Magister c (+56950088329, rominagoza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensibility (time frame: Measured at 6 intervals (3 times sugar sweetened beverages and 3 times artificially sweetened beverages), separated at least by 1 week from each other. All the tests must be assessed during 10 weeks utmost.). 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 NCT02890108, which also lists 12 linked publications.
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 7 Sep 2016.