To Compare the Effects of Non-nutritive Sweeteners Intake in Subjects With T2DM
NCT03680482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2019-02-28
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.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- OTHER
-
Intervention ingest a 48 mg of sucralose
Intervention: Subjects with type 2 diabetes who ingest a 48 mg of sucralose. Sucralose is a non-caloric sweetener derived from sucrose and is 600 times more sweet than sucrose. Your allowable daily intake is 15 mg / kg of body weight per day. 85% is not absorbed and is excreted unchanged in the stool; the rest that is absorbed is excreted unchanged by the urine
- OTHER
-
Intervention ingest a 96 mg of stevia
Intervention: Subjects with type 2 diabetes who ingest a 96 mg of stevia (steviol glycosides). The word "stevia" refers to the whole plant of Stevia rebaudiana Bertoni (SRB), only some of the components of the stevia leaf are sweet. Steviol glycosides are up to 300 times sweeter than sucrose, do not provide calories and can be used as a substitute for sucrose or as a non-nutritive sweetener alternative. Your allowable daily intake is 4 mg / kg / body weight (expressed as steviol)
Sponsors & Collaborators
-
Sociedad Chilena de Nutrición
collaborator UNKNOWN -
University of Chile
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 30 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-11
- Primary Completion
- 2016-08-08
- Completion
- 2017-08-31
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