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Trial record 62 of 1012 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT03680482
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Sociedad Chilena de Nutrición
Information provided by (Responsible Party):
Pamela Rojas, University of Chile

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Intervention ingest a 48 mg of sucralose Other: Intervention ingest a 96 mg of stevia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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 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
Masking: Single (Participant)
Masking Description: the participant has no knowledge of the intervention assignment
Primary Purpose: Screening
Official Title: Comparative Analysis of Appetite-satiety, Glycemia, Insulin, Incretin Plasmatic Concentrations GLP-1 After the Intake of Non-nutritive Sweeteners in Diabetic Subjects Type 2
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : August 8, 2016
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Stevia

Arm Intervention/treatment
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.
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

No Intervention: Intervention ingest a water (control group)
Subjects with type 2 diabetes who ingest a water (control group)
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.
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)




Primary Outcome Measures :
  1. glycemic response in blood [ Time Frame: Three hours ]
    Area under the curve was built for each subjects after steviol or sucralose or water intake.


Secondary Outcome Measures :
  1. Insulin response in blood [ Time Frame: Three Hours ]
    Area under the curve was built for each subjects after steviol or sucralose or water intake.


Other Outcome Measures:
  1. 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.

  2. ghrelin response in blood [ Time Frame: Three Hours ]
    Area under the curve was built for each subjects after steviol or sucralose or water intake.

  3. 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.


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



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Pamela Rojas, Director, University of Chile
ClinicalTrials.gov Identifier: NCT03680482     History of Changes
Other Study ID Numbers: SUE
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela Rojas, University of Chile:
High-Intensity Sweeteners
insulin
ghrelin
Glucagon-Like Peptide 1
Non-Nutritive Sweeteners
Stevia rebaudiana

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases