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
- Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|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|
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
- 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.
- 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.
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
|Faculty of Medicine Ramathibodi Hospital, Mahidol University|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Chutintorn Sriphrapradang, M.D.||Ramathibodi Hospital|