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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

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Sucralose Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
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.
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

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.
Dietary Supplement: Placebo
Consumption of empty capsule everyday for 4 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650947


Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
The Endocrine Society of Thailand
Investigators
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Principal Investigator: Chutintorn Sriphrapradang, M.D. Ramathibodi Hospital

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Responsible Party: Chutintorn Sriphrapradang, Assistant Professor, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT02650947     History of Changes
Other Study ID Numbers: 09-58-16
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Chutintorn Sriphrapradang, Ramathibodi Hospital:
Sucralose
Insulin Secretion
Insulin Sensitivity
Incretin
Gut Microbiota
Food and Eating Behaviour
Healthy Volunteers
Additional relevant MeSH terms:
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Insulin
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists