CompletedNot Applicable

To Compare the Effects of Non-nutritive Sweeteners Intake in Subjects With T2DM

17 participantsStarted 2016-01-11

Plain-language summary

ABSTRACT Introduction: There is no current data about the effects of non-nutritive sweeteners (NNS) about important factors, such as the energy intake, appetite and its relationship in people with diabetes when tasting sweet. It is highly relevant to compare the effects of NNS intake, such as, stevia (steviol glycosides) and sucralose, previous to a mixed food on glycemic response, insulin and plasmatic concentrations of Glucagon-like peptide type 1 (GLP-1) and ghrelin in subjects with type 2 diabetes mellitus (T2DM). Objective: To compare the effects of non-nutritive sweeteners intake: stevia (steviol glyco-sides) and sucralose previous to mixed food on appetite, glycemia, insulin, ghrelin,incretin plasmatic concentrations GLP-1 in people with T2DM. Methods: Seventeen subjects with T2DM were studied in 3 different moments and they received 3 treatments: pre-load of water or sucralose or stevia and then offered to consume mixed food as a test, which provided 332 Kcal and 75 grams of available carbohydrates. Blood samples were obtained to measure the dependent variables, glycemic and insulin at times -10, 0, 30, 60, 90, 120, 150 and 180 minutes and GLP-1 with ghrelin, at times -10, 0, 30, 90, and 180 minutes. The analogue visual scale questionnaires (VAS) was conducted every 30 minutes in order to obtain the results of the depend variables: appetite and wish of specific type of food in a subjective way; appetite, satiety, relax, wish to eat any food, craving for something sweet, craving for something salty, something tasty, something fatty. Through food provided ad libi-tum (objective appetite), were obtained the results of: energy, carbohydrates, proteins and lipid intakes. The statistical analysis applied included the Shapiro-Wilk's Normality test, repeated measures ANOVA to assess differences among treatments, Friedman's test followed by Wilcoxon test corrected by Bonferroni as needed. The degree of association between variables was conducted using the Pearson's or Spearman's correlation coefficient tests, as requested. A probability value p \<0.05 was considered significant.

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with T2DM * Treatment with metformin and / or diet * Diabetes diagnosed more than 1 year and less than 10 years * Glycosylated hemoglobin (HbA1c) less than 9% * Body mass index (BMI) ≥25 kg / m2 and \<39.9 kg / m2 Exclusion Criteria: * Subjects who consume any other drug or dietary supplement that may interfere with appetite or satiety or their post-prandial glycemic and hormonal responses * Subjects with illness; acute, cardio-vascular significant, psychological, neurological, renal, alcohol or drug abuse * Subjects that have aversion or allergy to foods / sweeteners used in test meals. * Subjects with eating disorders and who have had gastrointestinal surgery of type: bariatric surgery, gastrectomy, Whip-ple or intestinal resections

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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What they're measuring

glycemic response in blood

Timeframe: Three hours

Trial details

NCT IDNCT03680482

SponsorUniversity of Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-08

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials