Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index
NCT ID: NCT03703141
Last Updated: 2018-10-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
95 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-27
Study Completion Date
2018-06-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The consumption of non-caloric sweeteners has increased worldwide; Current publications suggest its consumption associates to insulin resistance.
The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults.
In this prospective, randomized, double-blind, placebo-controlled clinical trial, three groups will be included with 30 healthy volunteers each. Group A will receive sucralose 48 mg/ day, group B 96 mg/day and group C plain water as placebo. Subjects will be exposed to acute (one day) and chronic (seventy days) oral sucralose ingestion. After acute or chronic exposure, volunteers will undergo into an Oral Glucose Tolerance Test (OGTT), taking blood samples at -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively.
Areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes as described; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only. Differences between one and seventy days AUC means will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compare between acute and chronic exposure. Also, a comparison between the percentage of acute and chronic microbiome bacterial population in feces will be made.
The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults.
In this prospective, randomized, double-blind, placebo-controlled clinical trial, three groups will be included with 30 healthy volunteers each. Group A will receive sucralose 48 mg/ day, group B 96 mg/day and group C plain water as placebo. Subjects will be exposed to acute (one day) and chronic (seventy days) oral sucralose ingestion. After acute or chronic exposure, volunteers will undergo into an Oral Glucose Tolerance Test (OGTT), taking blood samples at -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively.
Areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes as described; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only. Differences between one and seventy days AUC means will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compare between acute and chronic exposure. Also, a comparison between the percentage of acute and chronic microbiome bacterial population in feces will be made.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Sucralose in Insulin Sensitivity
NCT04182464
Insulin Sensitivity/Resistance
COMPLETED
NA
Metabolic Effects of Non-nutritive Sweeteners
NCT02413424
Obesity
COMPLETED
NA
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
NCT03407079
Healthy Volunteers
Overweight
RECRUITING
PHASE2
Sugar-replacement Sweeteners, and Blood Sugar Control
NCT01128829
Obesity
COMPLETED
NA
Sucralose and Glucose Metabolism in Young Healthy Adults
NCT07194772
Glucose Intolerance
Glucose and Insulin Response
Glucose Homeostasis
+10 more
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Introduction Overweight and obesity have increased along with the rate of other non-communicable diseases worldwide. At the same time, the consumption of non-caloric sweeteners (NCS) has risen considerably among the general population. Although international organizations such as Joint FAO/WHO Expert Committee on Food Additives (JECFA) has demonstrated NCS are safe; two recent publications suggested its consumption associates with insulin resistance.
Although the authors attributed the metabolic effect to changes in the composition of intestinal microbiota as a consequence of NCS ingestion, these studies lacked a robust clinical methodology, as their design were not randomized, comparative studies and the effect of NCS on systemic inflammation biomarkers were neglected.
Outcomes The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults.
Materials and methods It is a prospective, randomized, double-blind, placebo-controlled clinical trial, comparing three groups, with 30 healthy volunteers each, who will receive daily sucralose, for seventy days. After signing off informed consent, the first group will take 48 mg sucralose diluted in 60 mL of water; the second group will receive 96 mg / 60 ml a day, while the last group will receive 60 ml of plain water as placebo.
Inclusion criteria will be either sex, age between 18 and 35 years, with a body mass index (BMI) between 18.5 and 39.0, disease free, with light or moderate physical activity before entering the study, with a HOMA ≤3.8, non-smokers, non-alcohol drinkers, agreeing not to consume neither industrial food nor beverages related to NCS during the study, having Mexican ancestry, living in the Mexico City metropolitan area and signing informed consent to participate in the study.
Exclusion criteria Any acute disease by the time of recruitment, history of Type 1 or 2 diabetes, thyroid disease, adrenal glands disease, insulinoma, malabsorption syndrome, short bowel, HIV, any cancer, liver disease, renal disease, inflammatory bowel disease, have prescribed corticosteroids in the previous three months before enrollment or undergone to bariatric surgery. Having a BMI \<18.5 or \>39.0, working night shifts, unable to remain at the clinic for at least 5 hours, not accepting to stop consuming industrialized food or beverages containing NCS, not accepting to stop alcohol or tobacco consumption during the study, not consenting to participate, women in childbearing potential without pregnancy control or women pregnant or breastfeeding by the time of enrollment.
Each volunteer will be instructed to drink 60 mL of fluid containing either sucralose or water, every morning before meals for seventy days. Except on day one and day 70, when they will be requested to attend the clinic after fasting at least 8 hours. Two plastic containers to carry stool sample will be provided in advance to each participant and be requested to store a stool sample. At their arrival to the clinic the stool sample will be collected and labeled. Immediately after, they will be asked to drink the corresponding dose to day one or seventy in the presence of the investigators. Once the investigational material be drinking, an Oral Glucose Tolerance Test (OGTT), will be initiated, taking blood samples at
* 15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Analysis Demographics per group will be described initially. Following, areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes, as the measure points described above; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only.
Mean differences of AUCs between one and seventy days will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compared between acute and chronic exposure. Additionally, a comparison of changes between the percentage of acute and chronic microbiome population in feces will be made.
Although the authors attributed the metabolic effect to changes in the composition of intestinal microbiota as a consequence of NCS ingestion, these studies lacked a robust clinical methodology, as their design were not randomized, comparative studies and the effect of NCS on systemic inflammation biomarkers were neglected.
Outcomes The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults.
Materials and methods It is a prospective, randomized, double-blind, placebo-controlled clinical trial, comparing three groups, with 30 healthy volunteers each, who will receive daily sucralose, for seventy days. After signing off informed consent, the first group will take 48 mg sucralose diluted in 60 mL of water; the second group will receive 96 mg / 60 ml a day, while the last group will receive 60 ml of plain water as placebo.
Inclusion criteria will be either sex, age between 18 and 35 years, with a body mass index (BMI) between 18.5 and 39.0, disease free, with light or moderate physical activity before entering the study, with a HOMA ≤3.8, non-smokers, non-alcohol drinkers, agreeing not to consume neither industrial food nor beverages related to NCS during the study, having Mexican ancestry, living in the Mexico City metropolitan area and signing informed consent to participate in the study.
Exclusion criteria Any acute disease by the time of recruitment, history of Type 1 or 2 diabetes, thyroid disease, adrenal glands disease, insulinoma, malabsorption syndrome, short bowel, HIV, any cancer, liver disease, renal disease, inflammatory bowel disease, have prescribed corticosteroids in the previous three months before enrollment or undergone to bariatric surgery. Having a BMI \<18.5 or \>39.0, working night shifts, unable to remain at the clinic for at least 5 hours, not accepting to stop consuming industrialized food or beverages containing NCS, not accepting to stop alcohol or tobacco consumption during the study, not consenting to participate, women in childbearing potential without pregnancy control or women pregnant or breastfeeding by the time of enrollment.
Each volunteer will be instructed to drink 60 mL of fluid containing either sucralose or water, every morning before meals for seventy days. Except on day one and day 70, when they will be requested to attend the clinic after fasting at least 8 hours. Two plastic containers to carry stool sample will be provided in advance to each participant and be requested to store a stool sample. At their arrival to the clinic the stool sample will be collected and labeled. Immediately after, they will be asked to drink the corresponding dose to day one or seventy in the presence of the investigators. Once the investigational material be drinking, an Oral Glucose Tolerance Test (OGTT), will be initiated, taking blood samples at
* 15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Analysis Demographics per group will be described initially. Following, areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes, as the measure points described above; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only.
Mean differences of AUCs between one and seventy days will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compared between acute and chronic exposure. Additionally, a comparison of changes between the percentage of acute and chronic microbiome population in feces will be made.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Healthy
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
SCREENING
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sucralose 48 mg
Sucralose 48 mg in 60 ml of water O.D. for ten weeks
Group Type
EXPERIMENTAL
sucralose 48 mg (splenda)/day for ten weeks
Intervention Type
DIETARY_SUPPLEMENT
volunteers will take sucralose or placebo daily for 70 days
Sucralose 96 mg
sucralose 96 mg in 60 ml of water O.D. for ten weeks
Group Type
EXPERIMENTAL
sucralose 48 mg (splenda)/day for ten weeks
Intervention Type
DIETARY_SUPPLEMENT
volunteers will take sucralose or placebo daily for 70 days
Placebo
60 ml of water as placebo O.D. for ten weeks
Group Type
PLACEBO_COMPARATOR
sucralose 48 mg (splenda)/day for ten weeks
Intervention Type
DIETARY_SUPPLEMENT
volunteers will take sucralose or placebo daily for 70 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sucralose 48 mg (splenda)/day for ten weeks
volunteers will take sucralose or placebo daily for 70 days
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
sucralose 96 mg (splenda)/day for ten weeks
placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men or women
* Ages between 18 and 35 years
* Must not have suffered chronic noncommunicable or infectious diseases
* Must have been practicing light-moderate physical activity before the study
* Normal insulin resistance index according to a homeostatic model value of insulin resistance (HOMA-IR) ≤ 3.8
* Must not be smokers
* They must accept not to consume industrialized foods that contain non-caloric sweeteners during their participation in the study and be agree to receive weekly telephone reminders during the protocol
* Must accept not to consume industrialized beverages containing non-caloric sweeteners during their participation in the study
* Do not consume alcoholic beverages during their participation in the study, do not have alcoholism history and have not consumed alcoholic beverages for less than two weeks before entering to the protocol
* Must have Mexican ancestry
* The volunteers, their parents and grandparents must be from Mexico city metropolitan area
* They must sign the letter of inform consent, expressing their desire to participate as volunteers in the study
* Ages between 18 and 35 years
* Must not have suffered chronic noncommunicable or infectious diseases
* Must have been practicing light-moderate physical activity before the study
* Normal insulin resistance index according to a homeostatic model value of insulin resistance (HOMA-IR) ≤ 3.8
* Must not be smokers
* They must accept not to consume industrialized foods that contain non-caloric sweeteners during their participation in the study and be agree to receive weekly telephone reminders during the protocol
* Must accept not to consume industrialized beverages containing non-caloric sweeteners during their participation in the study
* Do not consume alcoholic beverages during their participation in the study, do not have alcoholism history and have not consumed alcoholic beverages for less than two weeks before entering to the protocol
* Must have Mexican ancestry
* The volunteers, their parents and grandparents must be from Mexico city metropolitan area
* They must sign the letter of inform consent, expressing their desire to participate as volunteers in the study
Exclusion Criteria
* People who have any kind of serious illness at the time of the selection
* People who have been diagnosed with Diabetes Mellitus type 1 or type 2
* People who have been diagnosed with thyroid disease
* People who have been diagnosed with any adrenal glands disease
* People who have been diagnosed with insulinoma
* People who have been diagnosed with malabsorption syndrome
* People with short bowel history
* People who have been diagnosed with HIV
* People who have been diagnosed with any type of neoplasia
* People who have been diagnosed with acute or chronic liver disease
* People who have been diagnosed with kidney disease with compromise on serum glucose levels
* People who have been prescribed with corticosteroid in the last 3 months before entering to the study
* People who have been prescribed with any type of antibiotic, 4 weeks prior to entering to the protocol
* People who have been prescribed with any type of non-steroidal anti-inflammatory, 4 weeks prior to entering the protocol
* People who do not accept to remain in the Clinical Pharmacology Unit during the required time to carry out the oral glucose tolerance curves (4 hours, plus the preparation time)
* People with night jobs
* People who did not accept to abstain from consuming industrialized products containing non-caloric sweeteners during their participation in the study
* People who refused to abstain from consuming industrialized beverages containing non-caloric sweeteners during their participation in the study
* People who do not accept to abstain from consuming alcoholic beverages during their participation in the study
* People who have undergone bariatric surgery before the study
* People with inflammatory bowel disease history
* People who have smoked at least 3 cigarettes per week in the last 3 months
* People who do not sign the informed consent letter to participate in the study
* Women on reproductive age without contraception therapy.
* Pregnant women
* Women who are breastfeeding at the time of evaluating their admission to the study,
* People who have been diagnosed with Diabetes Mellitus type 1 or type 2
* People who have been diagnosed with thyroid disease
* People who have been diagnosed with any adrenal glands disease
* People who have been diagnosed with insulinoma
* People who have been diagnosed with malabsorption syndrome
* People with short bowel history
* People who have been diagnosed with HIV
* People who have been diagnosed with any type of neoplasia
* People who have been diagnosed with acute or chronic liver disease
* People who have been diagnosed with kidney disease with compromise on serum glucose levels
* People who have been prescribed with corticosteroid in the last 3 months before entering to the study
* People who have been prescribed with any type of antibiotic, 4 weeks prior to entering to the protocol
* People who have been prescribed with any type of non-steroidal anti-inflammatory, 4 weeks prior to entering the protocol
* People who do not accept to remain in the Clinical Pharmacology Unit during the required time to carry out the oral glucose tolerance curves (4 hours, plus the preparation time)
* People with night jobs
* People who did not accept to abstain from consuming industrialized products containing non-caloric sweeteners during their participation in the study
* People who refused to abstain from consuming industrialized beverages containing non-caloric sweeteners during their participation in the study
* People who do not accept to abstain from consuming alcoholic beverages during their participation in the study
* People who have undergone bariatric surgery before the study
* People with inflammatory bowel disease history
* People who have smoked at least 3 cigarettes per week in the last 3 months
* People who do not sign the informed consent letter to participate in the study
* Women on reproductive age without contraception therapy.
* Pregnant women
* Women who are breastfeeding at the time of evaluating their admission to the study,
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital General de México Dr. Eduardo Liceaga
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guillermo Melendez
Projects record and follow-up chief
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillermo Melendez, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Mexico Eduardo Liceaga
References
Explore related publications, articles, or registry entries linked to this study.
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
Reference Type
BACKGROUND
Garcia LM, da Silva KS, Del Duca GF, da Costa FF, Nahas MV. Sedentary behaviors, leisure-time physical inactivity, and chronic diseases in Brazilian workers: a cross sectional study. J Phys Act Health. 2014 Nov;11(8):1622-34. doi: 10.1123/jpah.2012-0423. Epub 2014 Apr 11.
Reference Type
BACKGROUND
Perez-Rodriguez M, Melendez G, Nieto C, Aranda M, Pfeffer F. Dietary and physical activity/inactivity factors associated with obesity in school-aged children. Adv Nutr. 2012 Jul 1;3(4):622S-628S. doi: 10.3945/an.112.001974.
Reference Type
BACKGROUND
Lewis HB, Forwood SE, Ahern AL, Verlaers K, Robinson E, Higgs S, Jebb SA. Personal and social norms for food portion sizes in lean and obese adults. Int J Obes (Lond). 2015 Aug;39(8):1319-24. doi: 10.1038/ijo.2015.47. Epub 2015 Apr 14.
Reference Type
BACKGROUND
Hernandez B, Gortmaker SL, Colditz GA, Peterson KE, Laird NM, Parra-Cabrera S. Association of obesity with physical activity, television programs and other forms of video viewing among children in Mexico city. Int J Obes Relat Metab Disord. 1999 Aug;23(8):845-54. doi: 10.1038/sj.ijo.0800962.
Reference Type
BACKGROUND
Stamatakis E, Hillsdon M, Mishra G, Hamer M, Marmot M. Television viewing and other screen-based entertainment in relation to multiple socioeconomic status indicators and area deprivation: the Scottish Health Survey 2003. J Epidemiol Community Health. 2009 Sep;63(9):734-40. doi: 10.1136/jech.2008.085902. Epub 2009 Apr 27.
Reference Type
BACKGROUND
Glazier RH, Creatore MI, Weyman JT, Fazli G, Matheson FI, Gozdyra P, Moineddin R, Kaufman-Shriqui V, Booth GL. Density, destinations or both? A comparison of measures of walkability in relation to transportation behaviors, obesity and diabetes in Toronto, Canada. PLoS One. 2014 Jan 14;9(1):e85295. doi: 10.1371/journal.pone.0085295. eCollection 2014.
Reference Type
BACKGROUND
National Research Council (US). The Public Health Effects of Food Deserts: Workshop Summary. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK208019/
Reference Type
BACKGROUND
Grotz VL, Munro IC. An overview of the safety of sucralose. Regul Toxicol Pharmacol. 2009 Oct;55(1):1-5. doi: 10.1016/j.yrtph.2009.05.011. Epub 2009 May 21.
Reference Type
BACKGROUND
Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. doi: 10.1172/JCI27280.
Reference Type
BACKGROUND
Paredes-Turrubiarte G, Gonzalez-Chavez A, Perez-Tamayo R, Salazar-Vazquez BY, Hernandez VS, Garibay-Nieto N, Fragoso JM, Escobedo G. Severity of non-alcoholic fatty liver disease is associated with high systemic levels of tumor necrosis factor alpha and low serum interleukin 10 in morbidly obese patients. Clin Exp Med. 2016 May;16(2):193-202. doi: 10.1007/s10238-015-0347-4. Epub 2015 Apr 18.
Reference Type
BACKGROUND
Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.
Reference Type
BACKGROUND
Papapanagiotou A, Siasos G, Kassi E, Gargalionis AN, Papavassiliou AG. Novel Inflammatory Markers in Hyperlipidemia: Clinical Implications. Curr Med Chem. 2015;22(23):2727-43. doi: 10.2174/0929867322666150520095008.
Reference Type
BACKGROUND
Borgeson E, Johnson AM, Lee YS, Till A, Syed GH, Ali-Shah ST, Guiry PJ, Dalli J, Colas RA, Serhan CN, Sharma K, Godson C. Lipoxin A4 Attenuates Obesity-Induced Adipose Inflammation and Associated Liver and Kidney Disease. Cell Metab. 2015 Jul 7;22(1):125-37. doi: 10.1016/j.cmet.2015.05.003. Epub 2015 Jun 4.
Reference Type
BACKGROUND
Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.
Reference Type
BACKGROUND
Fakhouri TH, Kit BK, Ogden CL. Consumption of diet drinks in the United States, 2009-2010. NCHS Data Brief. 2012 Oct;(109):1-8.
Reference Type
RESULT
Pepino 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.
Reference Type
RESULT
Suez 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.
Reference Type
RESULT
Grotz VL, Jokinen JD. Comment on Pepino et al. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes care 2013;36:2530-2535. Diabetes Care. 2014 Jun;37(6):e148. doi: 10.2337/dc13-2972. No abstract available.
Reference Type
RESULT
Hocking SL, Stewart RL, Brandon AE, Suryana E, Stuart E, Baldwin EM, Kolumam GA, Modrusan Z, Junutula JR, Gunton JE, Medynskyj M, Blaber SP, Karsten E, Herbert BR, James DE, Cooney GJ, Swarbrick MM. Subcutaneous fat transplantation alleviates diet-induced glucose intolerance and inflammation in mice. Diabetologia. 2015 Jul;58(7):1587-600. doi: 10.1007/s00125-015-3583-y. Epub 2015 Apr 22.
Reference Type
RESULT
Fjaere E, Aune UL, Roen K, Keenan AH, Ma T, Borkowski K, Kristensen DM, Novotny GW, Mandrup-Poulsen T, Hudson BD, Milligan G, Xi Y, Newman JW, Haj FG, Liaset B, Kristiansen K, Madsen L. Indomethacin treatment prevents high fat diet-induced obesity and insulin resistance but not glucose intolerance in C57BL/6J mice. J Biol Chem. 2014 Jun 6;289(23):16032-45. doi: 10.1074/jbc.M113.525220. Epub 2014 Apr 17.
Reference Type
RESULT
Krysiak R, Gdula-Dymek A, Okopien B. Monocyte-suppressing effect of high-dose metformin in fenofibrate-treated patients with impaired glucose tolerance. Pharmacol Rep. 2013;65(5):1311-6. doi: 10.1016/s1734-1140(13)71489-0.
Reference Type
RESULT
Suarez-Alvarez K, Solis-Lozano L, Leon-Cabrera S, Gonzalez-Chavez A, Gomez-Hernandez G, Quinones-Alvarez MS, Serralde-Zuniga AE, Hernandez-Ruiz J, Ramirez-Velasquez J, Galindo-Gonzalez FJ, Zavala-Castillo JC, De Leon-Nava MA, Robles-Diaz G, Escobedo G. Serum IL-12 is increased in Mexican obese subjects and associated with low-grade inflammation and obesity-related parameters. Mediators Inflamm. 2013;2013:967067. doi: 10.1155/2013/967067. Epub 2013 Feb 20.
Reference Type
RESULT
Qu HQ, Li Q, Rentfro AR, Fisher-Hoch SP, McCormick JB. The definition of insulin resistance using HOMA-IR for Americans of Mexican descent using machine learning. PLoS One. 2011;6(6):e21041. doi: 10.1371/journal.pone.0021041. Epub 2011 Jun 14.
Reference Type
RESULT
Klein DA, Boudreau GS, Devlin MJ, Walsh BT. Artificial sweetener use among individuals with eating disorders. Int J Eat Disord. 2006 May;39(4):341-5. doi: 10.1002/eat.20260.
Reference Type
RESULT
Allison DB, Paultre F, Maggio C, Mezzitis N, Pi-Sunyer FX. The use of areas under curves in diabetes research. Diabetes Care. 1995 Feb;18(2):245-50. doi: 10.2337/diacare.18.2.245.
Reference Type
RESULT
Bueno-Hernandez N, Esquivel-Velazquez M, Alcantara-Suarez R, Gomez-Arauz AY, Espinosa-Flores AJ, de Leon-Barrera KL, Mendoza-Martinez VM, Sanchez Medina GA, Leon-Hernandez M, Ruiz-Barranco A, Escobedo G, Melendez G. Chronic sucralose consumption induces elevation of serum insulin in young healthy adults: a randomized, double blind, controlled trial. Nutr J. 2020 Apr 13;19(1):32. doi: 10.1186/s12937-020-00549-5.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form: Ethics Committee Aproval
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form: Informed Consent Form signed by all the volunteers
Related Links
Access external resources that provide additional context or updates about the study.
http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/
FDA. Food Additives \& Ingredients. 2015
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
261575
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effects of Sucralose in Gut Intestinal Microbiota and Postprandial GLP-1
NCT06094894
COMPLETED
NA
Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
NCT05810337
COMPLETED
NA
Sucralose Effects on Glucose Metabolism and Gut Microbiota
NCT02650947
COMPLETED
NA
The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose
NCT02075333
COMPLETED
NA
Metabolic Effects of Non-Nutritive Sweeteners
NCT01200940
COMPLETED
PHASE1/PHASE2
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
NCT02335021
COMPLETED
NA
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
NCT02459535
COMPLETED
NA
Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses
NCT02973334
COMPLETED
NA
Enteroendocrine Hormonal Response After the Ingestion of Cola Beverages With Sucrose and Non-nutritive Sweeteners
NCT05654285
COMPLETED
NA
To Compare the Effects of Non-nutritive Sweeteners Intake in Subjects With T2DM
NCT03680482
COMPLETED
NA
The Dose Effects of Isomaltulose and Sucrose on Glycaemic and Insulinemic Response
NCT04653207
COMPLETED
NA
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
NCT04118257
COMPLETED
NA
Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility
NCT02890108
UNKNOWN
NA
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect
NCT03806920
COMPLETED
NA
Effect of D-allulose in Addition to Oral Sucrose Load
NCT02714413
COMPLETED
PHASE2
Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)
NCT06315725
RECRUITING
Effects of Low/No Calorie Sweeteners on Glucose Tolerance
NCT04904133
COMPLETED
NA
Sucralose, Stevia, Gut Microbiome and Glucose Metabolism
NCT02800707
COMPLETED
NA
Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes
NCT05337098
RECRUITING
NA
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
NCT04966299
RECRUITING
NA
Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners
NCT06387316
ACTIVE_NOT_RECRUITING
NA
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
NCT02569762
COMPLETED
NA
Strategies To OPpose Sugars With Non-nutritive Sweeteners Or Water (STOP Sugars NOW) Trial
NCT03543644
COMPLETED
NA
Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety
NCT04226911
COMPLETED
NA
Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose
NCT06799715
RECRUITING
NA