Effect of Consumption of Non Caloric Sweeteners and Insulin Sensibility

NCT ID: NCT02890108

Last Updated: 2016-09-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugar sweetened beverages

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

Group Type EXPERIMENTAL

Sugar sweetened beverages

Intervention Type DIETARY_SUPPLEMENT

350 cc (1 can) of sugar sweetened beverage

Artificially sweetened beverage

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

Group Type EXPERIMENTAL

Artificially sweetened beverages

Intervention Type DIETARY_SUPPLEMENT

350 cc (1 can) of artificially sweetened beverage

Interventions

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Sugar sweetened beverages

350 cc (1 can) of sugar sweetened beverage

Intervention Type DIETARY_SUPPLEMENT

Artificially sweetened beverages

350 cc (1 can) of artificially sweetened beverage

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Sugar sweetened drinks Artificially sweetened drinks

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Nutrición y Tecnología de los Alimentos

OTHER

Sponsor Role lead

Responsible Party

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Romina Goza Ferreira

magister thesis student in adult clinical nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Romina A Goza Ferreira, Magister c

Role: PRINCIPAL_INVESTIGATOR

Institute of Nutrition and Tecnology of Food, University of Chile

Sandra Hirsch Birn, Magister

Role: STUDY_DIRECTOR

Institute of Nutrition and Tecnology of Food, University of Chile

Locations

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Institute of Nutrition and Tecnology of Food, University of Chile

Santiago, Metropolitan Region, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Romina A Goza Ferreira, Magister c

Role: CONTACT

+56950088329

Sandra Hirsch Birn, Magister

Role: CONTACT

+56229781495 ext. +56229781499

Facility Contacts

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Verónica Cornejo Espinoza, Director

Role: primary

+56229781 410

Sandra Hirsch Birn, Academic

Role: backup

+56229781495 ext. +56229781499

References

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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.

Reference Type BACKGROUND
PMID: 23318721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21430119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19151203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26095119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23850261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23088901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20303371 (View on PubMed)

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 BACKGROUND
PMID: 25231862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25313461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19808921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25271009 (View on PubMed)

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 BACKGROUND
PMID: 23633524 (View on PubMed)

Other Identifiers

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EANC-1

Identifier Type: -

Identifier Source: org_study_id

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