A Randomized Controlled Trial Examining Feasibility and Effect of Dietary Resistant Starch Supplementation in People Living with Human Immunodeficiency Virus in India

Background and Aims: Human immunodeficiency virus (HIV) and antiretroviral therapy (ART) result in aberrant gastrointestinal (GI) function. Resistant starch (RS) is a prebiotic that resists digestion in the upper GI tract, undergoes fermentation in the colonic and rectal lumen, and is associated with improved gut health. We aimed to determine the feasibility and effect of dietary RS supplementation in people living with HIV. Materials and Methods: In a two-arm double-crossover study, participants consumed rotis containing moderate- or high-dose RS for 14-day periods, separated by washout periods of normal diet. Feasibility was assessed by self-reported tolerability data and adherence data recorded by the field worker. Fecal and blood samples were collected at baseline and regular intervals to assess luminal fermentation, bacterial diversity, and HIV immune outcomes. Results: Six people living with HIV were recruited from a tertiary teaching hospital. Five participants completed the study. All were male, receiving ART, with CD4+ T-cell counts >200 cells/mm 3 . The dietary intervention was well-tolerated, and adherence was 100%. Fecal pH, short-chain fatty acids, and blood CD4+ T-cells were not altered by either diet when compared to baseline or normal diet periods. Alpha diversity measured by Pielou’s evenness showed significantly higher microbial evenness following normal diet when compared to moderate-dose ( P = 0.001, 95% confidence interval [CI]: 0.026–0.094) and high-dose supplementation ( P = 0.036, 95% CI: 0.002–0.070). Other markers of gut microbiota composition were not altered by supplementation. Conclusion: RS supplementation was feasible in this population during this COVID-19-constrained study. Supplementation for 14 days may have been insufficient to effect physiological changes. This study was prospectively registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12619000739112. Participant information and consent forms and the study protocol can be obtained by searching https://www.anzctr.org.au/with the above Trial ID. Sequence data are publicly available from the Sequence Read Archive repository under the BioProject accession PRJNA1156308.