Status:
COMPLETED
Effects of Sucralose in Gut Intestinal Microbiota and Postprandial GLP-1
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
GLP-1
Gut Microbiota
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
Recently, it has been proposed that the consumption of non-nutritive sweeteners, including sucralose, it's not harmless and is related with metabolic effects. Some studies have reported that sucralose...
Detailed Description
Study design: This is a triple-blind, parallel, placebo-controlled, randomized clinical trial. Sample size: The sample size was calculated to observe a difference of 20% in the Matsuda index betwee...
Eligibility Criteria
Inclusion
- Normal BMI (18.5-24.9 kg/m2)
- Low habitual consumption of non-nutritive sweeteners (NNS
- Fasting plasma insulin concentration of \<12 mU/L
Exclusion
- Diabetes or altered glucose metabolism (abnormal fasting glucose, glucose intolerance or elevated glycated hemoglobin)
- Use of antibiotics in the last 3 months
- Use of probiotics through pharmaceutical products
- Liver or kidney disease
- Use of medications that could interfere with insulin sensitivity
- Severe intestinal diseases
- History of bariatric surgery
- Pregnancy or lactation
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06094894
Start Date
June 1 2023
End Date
March 1 2024
Last Update
April 4 2025
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080