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

February 26, 2019 updated by: Pamela Rojas, University of Chile

Comparative Analysis of Appetite-satiety, Glycemia, Insulin, Incretin Plasmatic Concentrations GLP-1 After the Intake of Non-nutritive Sweeteners in Diabetic Subjects Type 2

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.

Study Overview

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 subject 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 sucralose 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 metformin or other medication, to the sampling room of the Department of Nutrition (Faculty of Medicine, University of Chile). The study was only begun if they had a capillary glycemia <140%, 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 48 mg of sucralose or an equivalent volume with 96 mg of stevia (steviol glycosides), which they had to consume in less than 2 minutes, and then answer to a question about the "sensation" that came with drinking this preparation, to make an estimate of your predisposition to the taste of the sweetener: sweet, bitter, metallic or other flavor.

After 10 minutes, at "time 0" immediately after the second blood sample, the individuals consumed a mixed test meal consisting of a cup of tea with three teaspoons of sugar, plus 126 grams of a homemade bread. , without fat, using the bread maker, brand; program 3, traditional bread.

The following blood samples were taken at times 30, 60, 90, 120, 150 and 180 minutes after "time 0". In total, 42 ml of blood was extracted, in each time the glycemia and insulin were determined (4 ml was taken at a time). Furthermore, only at time -10, 0, 30, 90 and 180 minutes, the value of GLP-1 and ghrelin was determined (at this time, 2 ml extra was extracted 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, sucralose and stevia), was evaluated through Anova of repeated samples . To analyze the differences between plasma concentrations and AUC of insulin and GLP-1 per treatment (preload water, sucralose and stevia), Friedman's test was used, followed by Wilcoxon and adjusted by Bonferroni.

To identify differences between the perception of sweet, bitter, and metallic taste by treatment (preload water, sucralose and stevia) Friedman 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, sucralose and stevia), the Pearson correlation factor was used, in contrast to insulinemic response, incretin GLP-1 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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
No Intervention: Intervention ingest a water (control group)
Subjects with type 2 diabetes who ingest a water (control group)
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic response in blood
Time Frame: Three hours
Area under the curve was built for each subjects after steviol or sucralose or water intake.
Three hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin response in blood
Time Frame: Three Hours
Area under the curve was built for each subjects after steviol or sucralose or water intake.
Three Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
incretin plasmatic concentrations GLP-1 in blood
Time Frame: Three Hours
Area under the curve was built for each subjects after steviol or sucralose or water intake.
Three Hours
ghrelin response in blood
Time Frame: Three Hours
Area under the curve was built for each subjects after steviol or sucralose or water intake.
Three Hours
The analogue visual scale questionnaires (VAS)
Time Frame: 30 minutes

Used to measure the appetite sensation includes three characteristic concepts; hunger, fullness and satiety. Understanding hunger for: vital and indispensable physiological need to nourish our body; Fullness: State that invites to stop eating; and satiety as: Sensation of satisfaction. The visual analog scale (VAS) of 10 cm in length will be used with words anchored at each end, which expresses the most positive rating (value 10 cm) and the most negative (0 cm). It will be used to evaluate hunger, satiety, fullness, prospective food consumption, desire to eat something sweet, salty, tasty or fatty, scale whose reference is "Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord 2000; 24 (1): 38-48.

was conducted every 30 minutes in order to obtain the results of the depend variables.

30 minutes
Through food provided ad libitum (objective appetite)
Time Frame: 30 minutes
were obtained the results of: energy, carbohydrates, proteins and lipid intakes.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2016

Primary Completion (Actual)

August 8, 2016

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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