NCT03680482

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

Completed NA Last updated 28 February 2019

What this trial tests

NA trial testing Intervention ingest a 48 mg of sucralose in Diabetes Mellitus, Type 2 in 17 participants. Completed in 31 August 2017.

Timeline

11 January 2016

Primary endpoint
8 August 2016

31 August 2017

Quick facts

Lead sponsor	University of Chile
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	screening
Enrollment	17
Start date	11 January 2016
Primary completion	8 August 2016
Estimated completion	31 August 2017

Drugs / interventions tested

• Intervention ingest a 48 mg of sucralose
• Intervention ingest a 96 mg of stevia

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

University of Chile

Who can join

Adults 30 to 55, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-nutritive sweeteners for diabetes mellitus.
   Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, et al · · 2020 · cited 31× · PMID 32449201 · DOI 10.1002/14651858.cd012885.pub2