None listed
Conditions
Brief summary
Sucralose is the most widely used non-nutritive sweetener, and its health effects have been highly debated over the years. In particular, some studies have shown a harmful impact of this substance on glycemic response, insulin resistance, and body weight. We will conduct a chronic, crossover, single-blind, and randomized controlled study to evaluate the effects of sucralose exposure on glycemic and insulinemic response. The glycemic response will be analyzed by a continuous glucose monitoring (CGM) system during the evaluation period. During this period a meal tolerance test (MTT) will be also performed to analyze glycemic and insulin responses and changes in fasting biochemical parameters will also be determined. Since the gut microbiota has emerged as a factor modulating metabolic responses after sucralose consumption, we will study gut microbiota changes as a possible explanatory mechanism. This study will contribute to the strengthening of the evidence evaluating the effects of sucralose. In a public health context, these findings will be preponderant to guide recommendations for the consumption of food products containing sucralose for people with obesity or diabetes. We hypothesized that sucralose supplementation would increase glycemic response through modification of gut microbiota in obese subjects.
Interventions
A total of sixty participants will be included: thirty subjects with obesity, otherwise healthy (BMI over 30 kg/m2), and thirty with obesity and type 2 diabetes (T2D). Participants from both groups will be randomly allocated into one of the two treatment phases to receive daily either a) sucralose or b) placebo for eight weeks, each phase separated by four weeks washout period.
A dose of 2.5 mg/kg/day of sucralose from food grade (Tate & Lyle PLC, UK) will be administered to patients in the su
A total of sixty participants will be included: thirty subjects with obesity, otherwise healthy (BMI over 30 kg/m2), and thirty with obesity and type 2 diabetes (T2D). Participants from both groups will be randomly allocated into one of the two treatment phases to receive daily either a) sucralose or b) placebo for eight weeks, each phase separated by four weeks washout period. A dose of 2.5 mg/kg/day of sucralose from food grade (Tate & Lyle PLC, UK) will be administered to patients in the sucralose-arm. This dose is equivalent to 50% of acceptable daily intake (5 mg/kg/day, FDA). The study product will be provided in ready-to-use sachets to be mixed with a habitual beverage. Adherence will be evaluated with a specific format in which participants will register the number of sachets consumed each day.
Sponsors
Universidad Nacional Autonoma de Mexico
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-50. Both men and women 2. Body Mass Index (BMI) >30 kg/m2 3. Have maintained stable weight during three months prior to intervention 4. Non or low consumers of non-nutritive sweeteners (NNS) 5. No known allergies/intolerances to the NNS 6. Type 2 diabetic with HbA1c < 9.0, under lifestyle control or oral medication such as glibenclamide y/o metformin. 7. Not receiving insulin, or having a history of ketoacidosis
Exclusion criteria
1. Inability to give informed consent 2. Pregnant or breast-feeding females 3. Smoker or alcoholic 4. Are allergic to adhesive or having a food intolerance 5. Heart, liver, gastrointestinal or renal disorders
Outcome results
None listed