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Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

ABSTRACT: Background: Low-calorie sweeteners (LCSs) are found in many foods and beverages, but consumers may not realize their presence, and their role in appetite, weight, and health is controversial. Although consumption limits based on toxicologic safety are well established, the threshold required to exert clinically relevant metabolic effects is unknown.Objectives: This study aimed to determine whether individuals who do not report consumption of LCSs can be correctly characterized as "unexposed" and to investigate whether instructions to avoid LCSs are effective in minimizing exposure.Design: Eighteen healthy 18- to 35-y-old "nonconsumers" (<1 food or beverage with LCSs/mo) enrolled in a 2-wk trial designed to evaluate the effects of LCSs on the gut microbiota. The trial consisted of 3 visits. At baseline, participants were counseled extensively about avoiding LCSs. After the run-in, participants were randomly assigned to consume diet soda containing sucralose or carbonated water (control) 3 times/d for 1 wk. Food diaries were maintained throughout the study, and a spot urine sample was collected at each visit.Results: At baseline, 8 participants had sucralose in their urine (29.9-239.0 ng/mL; mean ± SD: 111.4 ± 91.5 ng/mL). After the run-in, sucralose was found in 8 individuals (2 of whom did not have detectable sucralose at baseline) and ranged from 25.0 to 1062.0 ng/mL (mean ± SD: 191.7 ± 354.2 ng/mL). Only 1 participant reported consumption of an LCS-containing food before her visit. After the intervention, sucralose was detected in 3 individuals randomly assigned to receive carbonated water (26-121 ng/mL; mean ± SD: 60.7 ± 52.4 ng/mL).Conclusions: Despite the selection of healthy volunteers with minimal reported LCS consumption, more than one-third were exposed to sucralose at baseline and/or before randomization, and nearly half were exposed after assignment to the control. This shows that instructions to avoid LCSs are not effective and that nondietary sources (e.g., personal care products) may be important contributors to overall exposure. This trial was registered at clinicaltrials.gov as NCT02877186.

SUBMITTER: Sylvetsky AC

PROVIDER: S-EPMC5366047 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

Sylvetsky Allison C AC Walter Peter J PJ Garraffo H Martin HM Robien Kim K Rother Kristina I KI

The American journal of clinical nutrition 20170222 4

<b>Background</b>: Low-calorie sweeteners (LCSs) are found in many foods and beverages, but consumers may not realize their presence, and their role in appetite, weight, and health is controversial. Although consumption limits based on toxicologic safety are well established, the threshold required to exert clinically relevant metabolic effects is unknown.<b>Objectives:</b> This study aimed to determine whether individuals who do not report consumption of LCSs can be correctly characterized as " ...[more]

PMID: 28228424

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Project description:BACKGROUND:Non-nutritive sweeteners (NNS) are widely consumed by humans due to their apparent innocuity, especially sucralose. However, several studies link sucralose consumption to weight gain and metabolic derangements, although data are still contradictory. OBJECTIVE:To determine the effect of acute and chronic consumption of sucralose on insulin and glucose profiles in young healthy adults. MATERIAL AND METHODS:This was a randomized, parallel, double-blind, placebo-controlled trial conducted in healthy young adults from 18 to 35?years old, without insulin resistance. A hundred thirty seven participants were randomized into three groups: a) volunteers receiving 48?mg sucralose, b) volunteers receiving 96?mg sucralose, and c) controls receiving water as placebo. All participants underwent a 3-h oral glucose tolerance test (OGTT) preceded by consuming sucralose or placebo 15?min before glucose load, at two time points: week zero (Wk0) and week ten (Wk10). Serum insulin and glucose were measured every 15?min during both OGTTs. RESULTS:Compared to Wk0, consumption of sucralose for 10?weeks provoked 1) increased insulin concentrations at 0?min (7.5?±?3.4 vs 8.8?±?4.1 ?IU/mL; p?=?0.01), 30?min (91.3?±?56.2 vs 110.1?±?49.4 ?IU/mL; p?=?0.05), 105?min (47.7?±?24.4 vs 64.3?±?48.2 ?IU/mL; p?=?0.04) and 120?min (44.8?±?22.1 vs 63.1?±?47.8 ?IU/mL; p?=?0.01) in the 48?mg sucralose group; 2) increased blood glucose at -?15?min (87.9?±?4.6 vs 91.4?±?5.4?mg/dL; p?=?0.003), 0?min (88.7?±?4 vs 91.3?±?6?mg/dL; p?=?0.04) and 120?min (95.2?±?23.7 vs 106.9?±?19.5?mg/dL; p?=?0.009) in the 48?mg sucralose group; 3) increased area under the curve (AUC) of insulin in both 48 and 96?mg sucralose groups (9262 vs 11,398; p?=?0.02 and 6962 vs 8394; p?=?0.12, respectively); and 4) reduced Matsuda index in the 48?mg sucralose group (6.04?±?3.19 vs 4.86?±?2.13; p?=?0.01). CONCLUSIONS:These data show that chronic consumption of sucralose can affect insulin and glucose responses in non-insulin resistant healthy young adults with normal body mass index (between 18.5 and 24.9?kg/m2), however, the effects are not consistent with dose; further research is required. CLINICAL TRIAL REGISTRY:NCT03703141.

Project description:BACKGROUND: Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. METHODS: We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. RESULTS: A combination of 500 or 1000 ?g/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 ?g/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues. CONCLUSIONS: aPDT has the potential to be a promising novel technical modality for dental plaque control. TRIAL REGISTRATION: This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (number UMIN000012504).

Project description:Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating (r = -0.181, p < 0.05) and with uncontrolled eating (r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control (r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating (r = 0.302, p < 0.001) and uncontrolled eating (r = 0.346, p < 0.001), and inversely associated with craving control (r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating (r = 0.275, p = 0.001), uncontrolled eating (r = 0.321, p < 0.001) and emotional eating (r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group (p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.

Dataset Information

Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

Publications

Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

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