Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study


Autoři: Ratna Sudha Madempudi aff001;  Jayesh J. Ahire aff001;  Jayanthi Neelamraju aff001;  Anirudh Tripathi aff002;  Satyavrat Nanal aff003
Působiště autorů: Centre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India aff001;  Life Veda Treatment and Research Centre, Worli, Mumbai, India aff002;  Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, India aff003
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0225168

Souhrn

Background

Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed.

Methods

A total of 79 eligible subjects (18–65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject’s Global assessment were also evaluated.

Results

Twelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved.

Conclusions

UB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.

Klíčová slova:

Blood sugar – Insulin – Lipoproteins – Mental health and psychiatry – Probiotics – Quality of life


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Článek vyšel v časopise

PLOS One


2019 Číslo 11