The intervention will consist of capsules filled with pure sucralose. Each capsule will contain 90 mg of sucralose. Participants will be asked to consume one capsule in each meal (three per day) in order to achieve an ingestion of 270 mg of sucralose, this quantity corresponds approximately to the 30% of the acceptable daily intake (ADI) of sucralose for a lean person. This was calculated based on the ADI established by the joint FAO/WHO expert committee on food additives (JECFA) of 15 mg per kg of body weight per day of sucralose.

The intervention will consist of capsules filled with placebo (cornstarch). Each capsule will contain 90 mg of cornstarch. Participants will be asked to consume one capsule in each meal (three per day) in order to achieve an ingestion of 270 mg of placebo, this quantity is in order to match the sucralose consumed in the intervention group.

Insulin Sensitivity/Resistance

Food additive used to replace sugar providing a sweet taste without calories

Sucralose

Cornstarch without significant physiological effects

Placebo

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Effects of Sucralose in Insulin Sensitivity, Intestinal Microbiota and Postprandial GLP-1

Changes in Insulin Sensitivity in Liver and Muscle, Intestinal Microbiota and Postprandial GLP-1 Concentration Due to Sucralose Consumption

To evaluate changes in liver insulin sensitivity after sucralose consumption in comparison to placebo

To evaluate changes in skeletal muscle insulin sensitivity after sucralose consumption in comparison to placebo

To compare the change in the relative abundance of colony forming units of bacterial genus and species after sucralose consumption in comparison to placebo through meseenger RNA sequencing

To evaluate the changes in postprandial GLP-1 concentrations during a mixed meal after sucralose consumption in comparison to placebo

To evaluate the changes in postprandial glucose concentrations during a mixed meal after sucralose consumption in comparison to placebo

To evaluate the changes in postprandial insulin concentrations during a mixed meal after sucralose consumption in comparison to placebo

To evaluate the changes in postprandial C-peptide concentrations during a mixed meal after sucralose consumption in comparison to placebo

To determine the effects of sucralose consumption in lipopolysaccharide concentrations in comparison to placebo

To determine the effects of sucralose consumption in C-reactive protein concentrations in comparison to placebo

To determine the effects of sucralose consumption in IL-6 concentrations in comparison to placebo

To determine the effects of sucralose consumption in tumor necrosis factor-alpha concentrations in comparison to placebo

Paloma Almeda-Valdés

Staff physician

Triple-blind, parallel, placebo-controlled, randomized clinical trial.

The use of identical capsules will allow the blinding, the capsules will be deposited in bottles numbered sequentially according to the enrollment process and neither the participants nor the researches will know the content of the capsules or the group assigned.

Obesity

D-allulose (psicose), a C-3 epimer of D-fructose, is defined one of the rare sugars since it is rarely found in nature. Rare sugars are monosaccharides which present in small quantities in commercial mixtures of D-glucose and D-fructose obtained from hydrolysis of sucrose or isomerization of D-glucose (5). D-allulose (psicose) has been demonstrated to be a non-calorie monosaccharide which has approximately 70% sweetness of sucrose. Various physiological activities of D-allulose (psicose) have been revealed. Of those, its glucose suppressive effect has been proven by both animal and clinical studies.

D-allulose

erythritol

Faculty of Medicine, Chiang Mai University

Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects

The Efficacy of D-allulose (Psicose) on Weight and Fat Loss and Insulin Resistance by a Randomized Double-blind, Parallel-group Study in Non-diabetic Obese Subjects

sweeteners/necrosis

Effects of Sucralose in Insulin Sensitivity, Intestinal Microbiota and Postprandial GLP-1

Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects

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