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

NCT03680482 | Completed DMC

• 1 other identifier: SUE
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

High-Intensity Sweeteners; insulin; ghrelin; Glucagon-Like Peptide 1; Non-Nutritive Sweeteners; Stevia rebaudiana

Outcome Measures

Primary Outcomes (1)

• glycemic response in blood

  Area under the curve was built for each subjects after steviol or sucralose or water intake.

  Three hours

Secondary Outcomes (1)

• Insulin response in blood

  Three Hours

Other Outcomes (4)

• incretin plasmatic concentrations GLP-1 in blood

  Three Hours

• ghrelin response in blood

  Three Hours

• The analogue visual scale questionnaires (VAS)

  30 minutes

Study Arms (3)

Intervention ingest a 48 mg of sucralose

OTHER

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.

Other: Intervention ingest a 48 mg of sucralose

Intervention ingest a water (control group)

NO INTERVENTION

Subjects with type 2 diabetes who ingest a water (control group)

Intervention ingest a 96 mg of stevia

OTHER

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.

Other: Intervention ingest a 96 mg of stevia

Interventions

Intervention ingest a 48 mg of sucralose OTHER

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

Intervention ingest a 48 mg of sucralose

Intervention ingest a 96 mg of stevia OTHER

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)

Intervention ingest a 96 mg of stevia

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead
• Sociedad Chilena de Nutrición: collaborator

Related Publications (1)

• Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.

  PMID: 32449201 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

trichlorosucrose; stevioside

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant has no knowledge of the intervention assignment
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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 ENN was reversed. Therefore, during the second or third intervention they were given to drink water with sucralose or stevia respectively

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: September 21, 2018
• Study Start: January 11, 2016
• Primary Completion: August 8, 2016
• Study Completion: August 31, 2017
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share