Glucose Tolerance Clinical Trial
Official title:
The Effect of Regular Consumption of Low/No Calorie Sweeteners on Glycemic Response and Glucagon Like Peptide-1 Secretion in Healthy Adults: A Randomized Controlled Trial
Verified date | May 2021 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the effects of chronic exposure to some low/no calorie sweeteners (LNCS) on glucose tolerance and glucagon like peptide 1 (GLP-1) release in healthy individuals. LNCS examined in this study are saccharin, sucralose and aspartame+acesulfame-K. The amounts of LNCS given to the participants are kept similar to daily life exposure; far less than the Acceptable Daily Intakes (ADIs) levels proposed by Food and Drug Administration (FDA) or European Food Safety Authority (EFSA).
Status | Completed |
Enrollment | 42 |
Est. completion date | July 2, 2019 |
Est. primary completion date | May 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy, - Normoglycemic, - Female, - 19-45 years old, - Weight-stable past 3 months Exclusion Criteria: - Insulin resistance, - Type 2 diabetes mellitus, - Presence of acute/chronic infection, - Use of medication that may affect glucose metabolism (thiazide diuretics, glucocorticoids, estrogen or beta blockers) - Chronic alcohol intake, - Regular consumption of diet soda (more than one can of soda per week) |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem Dr. Sinasi Can (Kadiköy) Hospital | Istanbul | Anadolu |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
Brown RJ, Rother KI. Non-nutritive sweeteners and their role in the gastrointestinal tract. J Clin Endocrinol Metab. 2012 Aug;97(8):2597-605. doi: 10.1210/jc.2012-1475. Epub 2012 Jun 7. Review. — View Citation
Fujita Y, Wideman RD, Speck M, Asadi A, King DS, Webber TD, Haneda M, Kieffer TJ. Incretin release from gut is acutely enhanced by sugar but not by sweeteners in vivo. Am J Physiol Endocrinol Metab. 2009 Mar;296(3):E473-9. doi: 10.1152/ajpendo.90636.2008. Epub 2008 Dec 23. — View Citation
Jang HJ, Kokrashvili Z, Theodorakis MJ, Carlson OD, Kim BJ, Zhou J, Kim HH, Xu X, Chan SL, Juhaszova M, Bernier M, Mosinger B, Margolskee RF, Egan JM. Gut-expressed gustducin and taste receptors regulate secretion of glucagon-like peptide-1. Proc Natl Acad Sci U S A. 2007 Sep 18;104(38):15069-74. Epub 2007 Aug 27. — View Citation
Ma J, Bellon M, Wishart JM, Young R, Blackshaw LA, Jones KL, Horowitz M, Rayner CK. Effect of the artificial sweetener, sucralose, on gastric emptying and incretin hormone release in healthy subjects. Am J Physiol Gastrointest Liver Physiol. 2009 Apr;296(4):G735-9. doi: 10.1152/ajpgi.90708.2008. Epub 2009 Feb 12. — View Citation
Miller PE, Perez V. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies. Am J Clin Nutr. 2014 Sep;100(3):765-77. doi: 10.3945/ajcn.113.082826. Epub 2014 Jun 18. — View Citation
Nakagawa Y, Nagasawa M, Yamada S, Hara A, Mogami H, Nikolaev VO, Lohse MJ, Shigemura N, Ninomiya Y, Kojima I. Sweet taste receptor expressed in pancreatic beta-cells activates the calcium and cyclic AMP signaling systems and stimulates insulin secretion. PLoS One. 2009;4(4):e5106. doi: 10.1371/journal.pone.0005106. Epub 2009 Apr 8. — View Citation
Rogers PJ, Hogenkamp PS, de Graaf C, Higgs S, Lluch A, Ness AR, Penfold C, Perry R, Putz P, Yeomans MR, Mela DJ. Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies. Int J Obes (Lond). 2016 Mar;40(3):381-94. doi: 10.1038/ijo.2015.177. Epub 2015 Sep 14. Review. — View Citation
Romo-Romo A, Aguilar-Salinas CA, Brito-Córdova GX, Gómez Díaz RA, Vilchis Valentín D, Almeda-Valdes P. Effects of the Non-Nutritive Sweeteners on Glucose Metabolism and Appetite Regulating Hormones: Systematic Review of Observational Prospective Studies and Clinical Trials. PLoS One. 2016 Aug 18;11(8):e0161264. doi: 10.1371/journal.pone.0161264. eCollection 2016. Review. — 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 gut microbiota. Nature. 2014 Oct 9;514(7521):181-6. doi: 10.1038/nature13793. Epub 2014 Sep 17. — View Citation
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. eCollection 2016. — View Citation
Temizkan 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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 Hours Plasma Glucose | Change from baseline plasma glucose levels at 4 weeks observed. Participants underwent a 3-h oral glucose tolerance test (3-h OGTT) by consuming a 250 mL 75 g glucose solution, and blood samples were collected at 60, 120, 180 min. | 3 hours | |
Primary | 3 Hours Plasma Insulin | Change from baseline insulin levels at 4 weeks observed. Participants underwent a 3-h oral glucose tolerance test (3-h OGTT) by consuming a 250 mL 75 g glucose solution, and blood samples were collected at 60, 120, 180 min. | 3 hours | |
Primary | Glucagon-like peptide-1 (GLP-1) release | Change from baseline fasting GLP-1 levels at 4 weeks observed. | Week 4 | |
Secondary | Body Weight | Change from baseline body weight at 4 weeks observed. Participants were weighed on a digital scale (Tanita MC 180) in fasted state. Weights were expressed in kilograms (kg). | Week 4 | |
Secondary | Fat Mass | Change from baseline fat mass (kg) at 4 weeks observed. Fat mass was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180). | Week 4 | |
Secondary | Fat-Free Mass | Change from baseline fat-free mass (kg) at 4 weeks observed. Fat-free mass was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180). | Week 4 | |
Secondary | Total Body Water | Change from baseline total body water (kg) at 4 weeks observed. Total body water was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180). | Week 4 | |
Secondary | Body Mass Index (BMI) | Change from baseline BMI at 4 weeks observed. BMI was calculated as weight (in kilograms) divided by the square of height (in meters). | Week 4 | |
Secondary | Waist Circumference | Change from baseline waist circumference (in centimeters) at 4 weeks observed. | Week 4 |
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