Is a Non-Caloric Sweeteners-Free Diet Good To Treat Functional Gastrointestinal Disorder Symptoms? A Randomized Controlled Trial

Abstract Background A diet containing Non-Caloric Sweeteners (NCS) is used to reduce calorie intake and blood sugar peaks in overweight and obese subjects. Nevertheless, some animal studies suggest that NCS consumption may increase Functional Gastrointestinal Disorder symptoms (FGDs); however, there are scant clinical trials in humans. The aim of the study was to compare the effect of consuming a diet containing NCS (c-NCS) versus a Non-Caloric Sweetener-free diet (NCS-f) on FGDs in adult volunteers. Methods This was a randomized, controlled, parallel-group study using two different diets for five weeks: diet c-NCS contained 50-100 mg/day NCS (80% sucralose and 20% aspartame, acesulfame K, and saccharin); NCS-f diet contained less than 10 mg/day NCS. FGDs were recorded according to the Rome III criteria, gastrointestinal symptom questionnaire, Bristol scale, food frequency questionnaire, and consumption questionnaire at the beginning (PreTx) and at the end (PostTx) of the study by a gastroenterologist and a nutritionist. This study conducted according to the CONSORT guidelines and it was registered at clinicaltrials.gov (identifier code: NCT04129762). Results Participants were more often women than men in both groups (59% and 62%), with a median age of 22 years. FGDs were similar in both groups at the beginning of the study (PreTx) but significantly increased in the diet c-NCS group after five weeks (PostTx). The percentage of participants with diarrhea (PreTx=19% versus PstTx=56%; p=0.02), post-prandial discomfort (PreTx=9% versus PstTx=39%; p=0.02), constipation (PreTx=30% versus PostTx=56%; p<0.01), and burning or retrosternal pain (PreTx=13% versus PostTx=33%; p<0.01) significantly increased in the diet c-NCS group. Conversely, abdominal pain (PreTx=15% versus PostTx=3%; p=0.04), post-prandial discomfort (PreTx=26% versus PostTx=6%; p=0.02), burning or retrosternal pain (PreTx=15% versus PostTx=0%; p=0.02), early satiety (PreTx=18% versus PostTx=3%; p<0.01), and epigastric pain (PreTx=38% versus PostTx=3%; p<0.01) significantly decreased in the NCS-f diet group. Conclusion This study shows that diet c-NCS associates with increased FGDs including diarrhea, post-prandial discomfort, constipation, and burning or retrosternal pain. Interestingly, NCS-f diet concurs with decreased FGDs such as abdominal pain, post-prandial discomfort, burning or retrosternal pain, early satiety, and epigastric pain. A NCS-f diet could be a complementary strategy to alleviate FGDs. Trial registration: The ethics committee of the hospital approved this study with the registration number DI/19/301/03/020. This trial was registered at clinicaltrials.gov (identifier code: NCT04129762).