Abstract
Background: Non-Nutritive Sweeteners (NNS) can help reduce calorie intake when substituted for added sugar. Some studies have reported detrimental effect of NNS on gut microbiome when given at high doses in animal models. Clinical studies have been done mostly in small sample sizes. This study aims to evaluate the effect of using sucralose in coffee, tea and fruit juices on gut microbiome in Asian Indian adults with type 2 diabetes (T2D). Method: A parallel arm, randomized trial was carried out for 12 weeks in adults with T2D aged 30-50 yrs and glycated haemoglobin between 7-11 %. Participants were randomized into Intervention group (sucralose added in beverages) and Control group (No sucralose). Both groups received standard of care for diabetes. Faecal samples were collected from participants, V3-V4 libraries were generated and sequenced using illumina Miseq NGS. Alpha and beta diversity were derived for both groups to assess within and between groups changes. Ratio of fermicutes to bacteroidetes was also computed. Results: Interim data of 38 participants who completed the study (Control group, n=14 and Intervention group, n=24) was analysed for changes in operational taxonomical units (OTU) of gut microbiome. Major phyla detected across all samples were Fermicutes, Actinobacteria, Bacteroidetes, Proteobacteria and Verrucomicrobiota. Alpha and beta diversity analysis showed no significant changes between intervention and control groups. Fermicutes to bacteroidetes ratio did not show any significant difference between groups. At end of 12 weeks significant reduction in body weight (p<0.004) and body fat % (p<0.04) was observed in the intervention group. Conclusion: Use of sucralose in beverages produced no significant change in gut microbiome in Asian Indian adults with T2D but helped in reduction of body weight and body fat. Clinical trial registry: CTRI/2021/04/032686 Disclosure V. Mohan: None. K. Abirami: None. G. Rajagopal: None. P. Soundararajan: None. R. Unnikrishnan: None. R. Anjana: None. S. Vasudevan: None. K. Kamala: None. Funding Zydus Wellness Products Ltd.
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