Food- vs. supplement-based very-low-energy diets and gut microbiome composition in women with high body mass index: A randomized controlled trial
Abstract
Summary 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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 47 participants or records.
Read the paper
Related studies
- Bile Acid 7α-Dehydroxylating Gut Bacteria Secrete Antibiotics that Inhibit Clostridium difficile: Role of Secondary Bile Acids
- Ketogenic diet alleviates colitis by reduction of colonic group 3 innate lymphoid cells through altering gut microbiome
- Altered gut microbiome composition and function are associated with gut barrier dysfunction in healthy relatives of patients with Crohn's disease
- Diet, obesity, and the gut microbiome as determinants modulating metabolic outcomes in a non-human primate model
- Immune Impairment Associated with Vitamin A Deficiency: Insights from Clinical Studies and Animal Model Research
- Glyphosate-based herbicides influence antioxidants, reproductive hormones and gut microbiome but not reproduction: A long-term experiment in an avian model
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.