To Compare the Effects of Non-nutritive Sweeteners Intake in Woman With Insulin Resistance
Condition: Insulin Resistance; Hyperinsulinism
MeSH terms: Insulin Resistance; Hyperinsulinism
Study type: Interventional

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 insulin resistance when tasting sweet. It is highly relevant to compare the effects of
      NNS intake, such as, stevia (steviol glycosides) and D-tagatose, previous to a 75-gram oral
      glucose tolerance test (OGTT) on glycaemic and C-peptide responses in women with insulin
      resistance.

      Objective: To compare the effects of non-nutritive sweeteners intake: stevia (steviol
      glyco-sides) and sucralose previous to OGTT on appetite, glycemia and C-peptide plasmatic
      concentrations in women with insulin resistance.

      Methods: Thirty-three women with T2DM were studied in 3 different moments and they received 3
      treatments: pre-load of water or D-tagatose or stevia and then offered to consume a 75-gram
      oral glucose tolerance test. Blood samples were obtained to measure the dependent variables,
      glycemic at times -10, 0, 30, 60, 90, 120 and 180 minutes and C-peptide at times -10, 30, 90,
      120 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.
    

Detailed description: 
      Protocol The experimental design was developed 3 times. Each intervention was performed
      separately for a minimum period of 7 days out and a maximum of 14 days, depending on the
      availability of the experimental subjects. Cross treatment design (crossover) each women
      serves as its own control The first intervention corresponded to the control group, in order
      to maintain the ignorance of the type of sweetener they were receiving, between day 7 or
      maximum 14 days post-intervention the order of the test of the NNS was reversed. Therefore,
      during the second or third intervention they were given to drink water with D-tagatose or
      stevia respectively. For each intervention a check list was followed.

      Subjects were asked to maintain their normal diet between study days and abstain from
      strenuous exercise and alcohol intake for 24 hours before each evaluation. The subjects
      attended with an 8-hour fast, without having ingested medication, to the sampling room of the
      Pharmacy Faculty, University of Valparaís. The study was only begun if they had a capillary
      glycemia <100%, measured through a glucometer.

      Then, they were asked to answer the analogue visual scale (VAS) questionnaire and an
      intravenous catheter was installed in the antecubital vein to take the blood samples at "time
      -10". Immediately, they were given to drink 60 ml of water or 60 ml of water with 5000 mg of
      D-tagatose or an equivalent volume with 15,3 mg of stevia (steviol glycosides), which they
      had to consume in less than 2 minutes.

      After 10 minutes, at "time 0" immediately after the second blood sample, the individuals
      consumed a 75-gram oral glucose tolerance test (OGTT).

      The following blood samples were taken at times 30, 60, 90, 120 and 180 minutes after "time
      0". In total, 28 ml of blood was extracted, in each time the glycemia and C-peptide were
      determined (4 ml was taken at a time).

      In addition, VAS questionnaires were applied every 30 minutes, from "time -10" to 180 minutes
      for appetite determinations.

      After completing the extraction of blood samples at 180 minutes and removing the intravenous
      catheter, the subjects were offered a meal for 30 minutes, which consisted of a variety of
      foods of high acceptability, previously weighed and fractionated.

      Statistic analysis The normal distribution of the variables was determined by the
      Shapiro-Wilk test. The natural logarithm was applied to the parameters without normal
      distribution. The variables were expressed as mean ± standard deviation or median plus
      interquartile interval (Q1-Q3). The statistical significance between the differences in
      plasma glucose concentrations, area under the curve (AUC) of glycaemia, energy intake and
      macronutrients by treatment (preload water, D-tagatose and stevia), was evaluated through
      Anova of repeated samples . To analyze the differences between plasma concentrations and AUC
      of C-peptide and glycaemia per treatment (preload water, D-tagatose and stevia), Friedman's
      test was used, followed by Wilcoxon and adjusted by Bonferroni.

      To identify the relationships between glycemic responses and intake of food at will (energy
      intake and macronutrients by treatment, preload water, D-tagatose and stevia), the Pearson
      correlation factor was used, in contrast to C-peptide response and the visual analogue scale
      (VAS) and food intake at will per treatment Spearman's correlation factor was used.

      The statistical analysis was performed with the SPSS 20.0 computer program (SPSS Inc.,
      Chicago Illinois). A p <0.05 was considered statistically significant for all the analyzes.
    

Intervention name(s): Intervention ingest a 5000 mg of D-tagatose; Intervention ingest a 15,3 mg of stevia
Intervention type(s): Other; Other
Intervention description(s): Woman with resistance insulin who ingest a 5000 mg of D-tagatose. D-tagatose is a sweetener of natural origin, low in calories (1.5 kcal / g) and with a sweetness power of 0.9.
About 20 to 25% of the ingested D-tagatose is absorbed and metabolized in the liver, the rest is fermented by the microbiota producing short chain fatty acids.; Woman with resistance insulin who ingest a 15,3 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)
Intervention MeSH terms: Tagatose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The experimental design was developed 3 times. Each intervention was performed separately for a minimum period of 7 days out and a maximum of 14 days, depending on the availability of the experimental subjects. Cross treatment design (crossover) each women serves as its own control The first intervention corresponded to the control group, in order to maintain the ignorance of the type of sweetener they were receiving, between day 7 or maximum 14 days post-intervention the order of the test of the NNS was reversed. Therefore, during the second or third intervention they were given to drink water with D-tagatose or stevia respectively
Masking: Single (Participant)
Primary purpose: Screening
Keywords: High-Intensity Sweeteners; Non-Nutritive Sweeteners; Stevia rebaudiana; C-Peptide; Blood Glucose