Lane, Melissa M., McGuinness, Amelia J., Mohebbi, Mohammadreza, Lotfaliany, Mojtaba, Loughman, Amy, O’Hely, Martin, O’Neil, Adrienne, Batti, Jessica, Kotowicz, Mark, Berk, Michael, Saunders, Lucy, Page, Richard, Beattie, Sally, Marx, Wolfgang, and Jacka, Felice N. (2025) Food- vs. supplement-based very-low-energy diets and gut microbiome composition in women with high body mass index: A randomized controlled trial. Cell Reports Medicine, 6 (10). 102417.

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Abstract

In a single-blind, two-arm, randomized controlled-feeding trial (May 2021–February 2022), 47 women (30–65 years, BMI 30–45 kg/m²) are randomized to either a food-based or a supplement-based very-low-energy diet (VLED: 800–900 kcal/d) for 3 weeks. The food-based VLED comprises pre-packaged meals (∼93% whole-food ingredients), while the supplement-based VLED comprises shakes, soups, bars, and desserts (∼70% industrial ingredients). The primary outcome is species-level alpha diversity (Shannon index). Secondary outcomes include species richness, beta diversity, taxonomic composition, functional potential, anthropometrics, serum biomarkers, mental health, sleep, and gastrointestinal symptoms. Modified intention-to-treat (mITT) analyses (n = 45) assess diet group × time interactions as beta coefficients (β) with 95% confidence intervals (CIs). A between-group differential change is observed for the Shannon index, with a greater increase in the food-based group (mITT β: 0.37, 95% CI: 0.15–0.60). The food-based group also shows greater species richness, smaller beta diversity shifts, and compositional changes preserving fiber-degrading, health-associated taxa.

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