Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

NCT02890108 | Unknown DMC

• 1 other identifier: EANC-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insulin Sensitivity

Keywords

High-Intensity Sweeteners; Non-Nutritive Sweeteners; Artificial sweeteners; Glucose intolerance

Outcome Measures

Primary Outcomes (1)

• 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 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

  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.

Study Arms (2)

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

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

Dietary Supplement: Artificially sweetened beverages

Interventions

Sugar sweetened beverages DIETARY_SUPPLEMENT

350 cc (1 can) of sugar sweetened beverage

Also known as: Sugar sweetened drinks

Sugar sweetened beverages

Artificially sweetened beverages DIETARY_SUPPLEMENT

350 cc (1 can) of artificially sweetened beverage

Also known as: Artificially sweetened drinks

Artificially sweetened beverage

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) between 18,5 - 24,9 kg/mt2
• Healthy men or women
• Fasting plasma glucose \< 100 mg/dL

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Nutrición y Tecnología de los Alimentos: lead

Study Sites (1)

Institute of Nutrition and Tecnology of Food, University of Chile

Santiago, Metropolitan Region, Chile

RECRUITING

Related Publications (12)

• 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.

  PMID: 23318721 BACKGROUND

• de 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.

  PMID: 21430119 BACKGROUND

• Nettleton 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.

  PMID: 19151203 BACKGROUND

• Pepino 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.

  PMID: 26095119 BACKGROUND

• Swithers 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.

  PMID: 23850261 BACKGROUND

• Feijo 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.

  PMID: 23088901 BACKGROUND

• Anton 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.

  PMID: 20303371 BACKGROUND

• 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.

  PMID: 25231862 BACKGROUND

• Palmnas 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.

  PMID: 25313461 BACKGROUND

• Brown 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.

  PMID: 19808921 BACKGROUND

• 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.

  PMID: 25271009 BACKGROUND

• 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.

  PMID: 23633524 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance

Interventions

Sugar-Sweetened Beverages; Artificially Sweetened Beverages

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Romina A Goza Ferreira, Magister c

  Institute of Nutrition and Tecnology of Food, University of Chile

  PRINCIPAL INVESTIGATOR

• Sandra Hirsch Birn, Magister

  Institute of Nutrition and Tecnology of Food, University of Chile

  STUDY DIRECTOR

Central Study Contacts

Romina A Goza Ferreira, Magister c

CONTACT

+56950088329; rominagoza@gmail.com

Sandra Hirsch Birn, Magister

CONTACT

+56229781495; shirsch@inta.uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: magister thesis student in adult clinical nutrition

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 7, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)