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Sucralose Effects on Glucose Metabolism and Gut Microbiota

M

Mahidol University

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Sucralose
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02650947
09-58-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups, including a placebo group

Sucralose
Experimental group
Description:
Subjects in this group ate capsule filled with sucralose 200 mg for 4 weeks (week 1-4) and measured oral glucose tolerance test (OGTT), acute insulin response (AIR), and gut microbe examination at week 4.
Treatment:
Dietary Supplement: Sucralose
Placebo
Placebo Comparator group
Description:
Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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