Sucralose Effects on Glucose Metabolism and Gut Microbiota

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