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Completed

NCT Number: NCT02650947

Sucralose Effects on Glucose Metabolism and Gut Microbiota

Hypothesis:

1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults. 2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

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Key information

Conditions

Healthy Behavior Behavior, Animal Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

About this study

Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers without underlying disease
  • Normal oral glucose tolerance test
  • Agree to participate by written informed consent

Exclusion criteria

  • Shift workers
  • History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
  • Malabsorption problem
  • Regular consumption of nonnutritive sweeteners
  • Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3-folds upper normal limit)
  • Renal impairment (serum creatinine >1.5 mg/dL)
  • Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
  • Pregnant and lactating woman
  • Smoking within 6 months

Treatment and study plan

Sucralose

Dietary Supplement

Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks

Other names: Trichlorosucrose

Placebo

Dietary Supplement

Consumption of empty capsule everyday for 4 weeks

Primary outcomes

  1. The effect of sucralose on insulin secretion

    Time frame: 2 hours

    We will measure plasma insulin concentrations before and at 0, 2, 3, 4, 5, 6, 8, 10 minutes after administered intravenously 50%glucose 0.3 g/kg within 1 minute. All these data collected were used to calculate acute insulin response to glucose.

Secondary outcomes

  1. Glucagon-like peptide-1 secretion

    Time frame: 2 hours

  2. Gut microbiota

    Time frame: 4 weeks

    stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing

  3. Food record

    Time frame: 4 weeks

  4. The effect of sucralose on insulin sensitivity

    Time frame: 2 hours

    We will measure plasma insulin concentrations during an oral glucose tolerance test.

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • The Endocrine Society of Thailand

Registry information

Official study title

Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2016
Registry last updated
Apr 27, 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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