White common bean extract remodels the gut microbiota and ameliorates type 2 diabetes and its complications: A randomized double-blinded placebo-controlled trial.

2022-10-11
Frontiers in endocrinology 13
- Yuwei Feng
- Jie Zhu
- Qinyue Wang
- Hong Cao
- Fang He
- Yin Guan
- Dan Li
- Jiai Yan
- Ju Yang
- Yanping Xia
- Meihua Dong
- Feng Hu
- Min Cao
- Jian Wang
- Xiaoying Ding
- Yufei Feng
- Hong Zou
- Ying Han
- Su Sun
- Jin Zhang
- Aijuan Tang
- Minhong Jiang
- Yu Deng
- Jianfen Gao
- Yanxin Jia
- Wei Zhao
- Feng Zhang

PubMed: 36303868
DOI: 10.3389/fendo.2022.999715

Study Design

Type: Randomized Controlled Trial (RCT)
Population: ninety subjects
Methods: 4-month randomized double-blinded placebo-controlled trial, subjects randomly assigned to control group (Group C) and WCBE group (Group W), Group C supplemented with 1.5 g of maltodextrin as placebo, Group W took 1.5 g of WCBE half an hour before a meal
Blinding: Double-blind
Duration: 4 months

Objective

Excessive carbohydrate intake is a high risk factor for increased morbidity of type 2 diabetes (T2D). A novel regimen for the dietary care of diabetes that consists of a highly active α-amylase inhibitor derived from white common bean extract (WCBE) and sufficient carbohydrates intake was applied to attenuate T2D and its complications. Furthermore, the role of gut microbiota in this remission was also investigated.

Methods

We conducted a 4-month randomized double-blinded placebo-controlled trial. During the intense intervention period, ninety subjects were randomly assigned to the control group (Group C) and WCBE group (Group W). Subjects in Group C were supplemented with 1.5 g of maltodextrin as a placebo. Subjects in Group W took 1.5 g of WCBE half an hour before a meal. Fifty-five participants continued the maintenance intervention receiving the previous dietary intervention whereas less frequent follow-up. The variation in biochemical, vasculopathy and neuropathy indicators and the structure of the fecal microbiota during the intervention was analyzed.

Result

Glucose metabolism and diabetic complications showed superior remission in Group W with a 0.721 ± 0.742% decline of glycosylated hemoglobin after 4 months. The proportion of patients with diabetic peripheral neuropathy (Toronto Clinical Scoring System, TCSS ≥ 6) was significantly lower in Group W than in Group C. Both the left and right sural sensory nerve conduction velocity (SNCV-left sural and SNCV-right sural) slightly decreased in Group C and slightly increased in Group W. Additionally, the abundances of Bifidobacterium, Faecalibacterium and Anaerostipes were higher in Group W, and the abundances of Weissella, Klebsiella, Cronobacter and Enterobacteriaceae_unclassified were lower than those in Group C at month 2. At the end of month 4, Bifidobacterium remained more abundant in Group W.

Conclusion

To our knowledge, this is the first report of improvement to diabetes complications by using a dietary supplement in such a short-term period. The enrichment of SCFA-producing bacteria might be responsible for the attenuation of T2D and its complications.

Clinical trial registration number

http://www.chictr.org.cn/edit.aspx?pid=23309&htm=4, identifier ChiCTR-IOR-17013656.