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Completed

NCT Number: NCT02589002

Effects of Sucralose on Glucose Metabolism

In this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

About this study

The consumption of non-nutritive sweeteners has a high prevalence. The effect of non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown.

Previous studies performed in animal models and humans with diverse characteristics have shown variable effects of different non-nutritive sweeteners in variables related to glucose metabolism.

Due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in beta cell-function and insulin sensitivity.

In this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in the population, on insulin sensitivity and beta-cell function will be evaluated.

54 participants with normal glucose tolerance, normal weight, and without chronic diseases with a low consumption of non-nutritive sweeteners will be included. The participants will be randomly assigned to consume sucralose or to a control group.

During the first visit an oral glucose tolerance test with 75 g of glucose will be performed. Fasting and 2-hour glucose will be measured in order to rule-out diabetes, abnormal fasting glucose, or glucose intolerance.

During the second visit a three-hour IV glucose tolerance test will be performed administering 0.3 g/kg of glucose and insulin 0.03 U/kg. Samples will be taken following the minimal model described by Bergman.

After this visit, the group assigned to receive sucralose will ingest 15% of the adequate daily intake (ADI) of sucralose and the control group will abstain of any non-nutritive sweetener consumption during 14 days. At the end of this period a third visit to repeat the IV glucose tolerance test will be performed.

Samples will be analyzed measuring glucose and insulin concentrations to evaluate acute insulin response (AIR), glucose effectiveness (SG), first phase pancreatic response (ф1), and second phase pancreatic response (ф2). In addition, hormones involved in appetite and satiety (leptin, ghrelin, and peptide tyrosine tyrosine) will be quantified at the beginning and end of the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • both genders
  • age between 18 and 55 years
  • body mass index ≥18.5 and <25 kg/m2
  • low consumption of non-nutritive sweeteners

Exclusion criteria

  • diabetes or glucose intolerance
  • consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives)
  • intestinal disease such as malabsorption or previous intestinal resection
  • history of bariatric surgery
  • pregnancy or lactation
  • weight loss greater than 5% in the previous month

Treatment and study plan

Sucralose

Other

Other names: Non-nutritive sweetener

Primary outcomes

  1. Insulin sensitivity

    Time frame: Two weeks

    Insulin sensitivity and pancreatic response estimated with the minimal model using a frequently sampled IV glucose tolerance test

Secondary outcomes

  1. Glucagon like peptide (GLP-1) change

    Time frame: Two weeks

    Change in fasting GLP-1 after sucralose ingestion

  2. Ghrelin change

    Time frame: Two weeks

    Change in fasting ghrelin after sucralose ingestion

  3. Tyrosine-tyrosine peptide (PYY) change

    Time frame: Two weeks

    Change in fasting PYY after sucralose ingestion

  4. Leptin change

    Time frame: Two weeks

    Change in fasting leptin after sucralose ingestion

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Effects of Sucralose on Insulin Sensitivity, Pancreatic Response and Appetite Regulating Hormones

Acronym: Sucralose

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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