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Sucralose Effects on Glucose Metabolism and Gut Microbiota

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ClinicalTrials.gov Identifier: NCT02650947
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
The Endocrine Society of Thailand
Information provided by (Responsible Party):
Chutintorn Sriphrapradang, Ramathibodi Hospital

Tracking Information
First Submitted Date  ICMJE January 2, 2016
First Posted Date  ICMJE January 8, 2016
Last Update Posted Date April 27, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • 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.
  • The effect of sucralose on insulin sensitivity [ Time Frame: 2 hours ]
    We will measure plasma insulin concentrations during an oral glucose tolerance test. Plasma insulin concentrations were measured before and at 30, 60, 90, and 120 min after ingesting 75 gram of glucose. All these data collected were used to create the area under the curve.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Glucagon-like peptide-1 secretion [ Time Frame: 2 hours ]
  • Gut microbiota [ Time Frame: 4 weeks ]
    stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing
  • Food record [ Time Frame: 4 weeks ]
  • The effect of sucralose on insulin sensitivity [ Time Frame: 2 hours ]
    We will measure plasma insulin concentrations during an oral glucose tolerance test.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Glucagon-like peptide-1 secretion [ Time Frame: 2 hours ]
  • Gut microbiota [ Time Frame: 4 weeks ]
    stool exam, polymerase chain reaction for 16s RNA gene using next generation sequencing
  • Food record [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sucralose Effects on Glucose Metabolism and Gut Microbiota
Official Title  ICMJE Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
Brief Summary

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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Sucralose
    Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks
    Other Name: Trichlorosucrose
  • Dietary Supplement: Placebo
    Consumption of empty capsule everyday for 4 weeks
Study Arms  ICMJE
  • Experimental: Sucralose
    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.
    Intervention: Dietary Supplement: Sucralose
  • Placebo Comparator: Placebo
    Subjects ate empty capsule (placebo) for 4 weeks (week 1-4) and measured OGTT, AIR, and gut microbe examination at week 4.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02650947
Other Study ID Numbers  ICMJE 09-58-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chutintorn Sriphrapradang, Ramathibodi Hospital
Study Sponsor  ICMJE Ramathibodi Hospital
Collaborators  ICMJE The Endocrine Society of Thailand
Investigators  ICMJE
Principal Investigator: Chutintorn Sriphrapradang, M.D. Ramathibodi Hospital
PRS Account Ramathibodi Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP