Healthy Clinical Trial
Official title:
Effect of Acute or Chronic Ingestion of Sucralose on Serum Insulin in Young and Healthy Adults: a Randomized, Double-blind, Placebo-controlled Trial
NCT number | NCT03703141 |
Other study ID # | 261575 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 27, 2016 |
Est. completion date | June 4, 2018 |
Verified date | October 2018 |
Source | Hospital General de México Dr. Eduardo Liceaga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | June 4, 2018 |
Est. primary completion date | June 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 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, |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital General de México Dr. Eduardo Liceaga |
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. — View Citation
Börgeson 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. — View Citation
Fakhouri TH, Kit BK, Ogden CL. Consumption of diet drinks in the United States, 2009?2010. NCHS Data Brief. 2012 Oct;(109):1-8. — View Citation
Fjære E, Aune UL, Røen 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 insu — View Citation
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. — View Citation
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. Erratum in: PLoS One. 2014;9(3):e91485. Shriqui, Vered Kaufman [corrected to Kaufman-Shriqui, Vered]. — View Citation
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. — View Citation
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. Review. — View Citation
Hernández 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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
National Research Council (US). The Public Health Effects of Food Deserts: Workshop Summary. Washington (DC): National Academies Press (US); 2009. — View Citation
Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. — View Citation
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253. — View Citation
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. Review. — View Citation
Paredes-Turrubiarte G, González-Chávez A, Pérez-Tamayo R, Salazar-Vázquez BY, Hernández 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Suárez-Álvarez K, Solís-Lozano L, Leon-Cabrera S, González-Chávez A, Gómez-Hernández G, Quiñones-Álvarez MS, Serralde-Zúñiga AE, Hernández-Ruiz J, Ramírez-Velásquez J, Galindo-González FJ, Zavala-Castillo JC, De León-Nava MA, Robles-Díaz G, Escobedo G. Se — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum insulin levels | To assess the effect of acute and chronic exposure to different sucralose concentrations differentiating the area under the curve levels in healthy, young volunteers, at a glucose tolerance test of 180 minutes. | Change the baseline serum insulin levels at 10 weeks sucralose consumption. | |
Secondary | C-peptide serum levels. | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum insulin levels at 10 weeks sucralose consumption. | |
Secondary | Glucose-dependent insulinotropic polypeptide serum levels. | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption. | |
Secondary | Glucagon serum levels | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum glucagon levels at 10 weeks sucralose consumption. | |
Secondary | Glucagon-like peptide-1 serum levels | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption. | |
Secondary | Systemic inflammatory response (pCr, Tumor Necrosis Factor , Internferon -, IL-1, IL-6, IL-12, IL-17, e IL-23 serum levels) | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption. | |
Secondary | Inflammatory monocytes (CD14hiCD16+ CD11c+CCR2hiCX3CR1lowCD206-) serum levels. | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum inflammatory monocytes levels at 10 weeks sucralose consumption. | |
Secondary | Anti-inflammatory markers (IL-4, IL-10, e IL-13) serum levels. | To assess the effect of acute and chronic exposure to different sucralose concentrations. | Change the baseline serum anti-inflammatory markers levels at 10 weeks sucralose consumption. | |
Secondary | Intestinal microbiota composition. | To assess the effect of chronic exposure to different sucralose concentrations. | Change the baseline intestinal microbiota composition at 10 weeks sucralose consumption. | |
Secondary | Body Mass Index (BMI) | To assess the effect of chronic exposure to different sucralose concentrations. | To compare the baseline body weight at 10 weeks sucralose consumption. | |
Secondary | Glucose area under the curve levels | Influence of Body Mass Index on the glucose mean area under the curve levels with different sucralose concentrations. | Change the baseline serum glucose levels at 10 weeks sucralose consumption. | |
Secondary | C-peptide area under the curve levels | Influence of Body Mass Index on the C-peptide mean area under the curve levels with different sucralose concentrations. | Change the baseline serum C-peptide levels at 10 weeks sucralose consumption. | |
Secondary | Glucagon area under the curve levels | Influence of Body Mass Index on the glucagon mean area under the curve levels with different sucralose concentrations. | Change the baseline serum glucagon levels at 10 weeks sucralose consumption. | |
Secondary | GLP-1 area under the curve levels | Influence of Body Mass Index on the GLP-1 mean area under the curve levels with different sucralose concentrations. | Change the baseline serum GLP-1 levels at 10 weeks sucralose consumption. | |
Secondary | Glucose-dependent insulinotropic polypeptide area under the curve levels. | Influence of Body Mass Index on the glucose-dependent insulinotropic polypeptide mean area under the curve levels with different sucralose concentrations. | Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |