High-fiber diets and lifestyle interventions have been shown to be the most effective ways to treat metabolic diseases such as obesity and diabetes, but which treatment is more effective and how effective the combination of these two interventions remain unclear. This study evaluated the clinical efficacy of a high-fiber and probiotic supplement diet (HFPD) combined with a lifestyle intervention (LSII) in overweight or obese patients with type 2 diabetes mellitus (T2DM) or prediabetes, and analyzed their impact on patients' gut microbiota and metabolomics. A randomized, double-blind, placebo-controlled trial was conducted in obese or overweight patients with T2DM or prediabetes (ChiCTR1800016411). 110 eligible participants were enrolled, randomly assigned to 4 groups (1:1:1:1) as following, HFPD add LSII group (HL), HFPD add non-LSII group (HNL), placebo add LSII group (PL), and placebo add non-LSII group (PNL) to complete the this 12-weeks treatment. Our results showed that HbA1c in the HL group decreased significantly compared with that in the PL group (-0.7±0.7% vs -0.4±0.9%, P=0.0166). The Hip circumference in PL group decreased more significantly than that in PNL group (-2.2±3.1 cm vs -0.2±3.6 cm, P=0.0244). In addition, compared with PNL group, HL group was significantly better in reducing body weight (-4.2±3.7kg vs -1.7±3.6 kg, p=0.0203), body mass index (-1.6±1.5kg/m2vs -0.7±1.3kg/m2, p=0.0249), hip circumference (-3.3cm±4.1cm vs -0.2±3.6cm, p=0.0070), HbA1c (-0.7±0.7% vs -0.2±0.7%, p=0.0147) and HOMA-IS (0.18±0.36 vs -0.01±0.20, p=0.0263). Combining further 16S rRNA sequencing and untargeted metabolomics studies suggests that HFPD and LSII both contribute to reducing weight and BMI in obese or overweight T2DM patients, and their combined use is particularly significant in improving metabolic parameters. This may be related to the improvement of the patients' gut environment.
X. Wang: None. J. Wen: None. L. Pang: None. P. Li: None. X. Geng: None. L. Zou: None. Z. Yang: None. X. Li: None. H. Lu: None.
