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Effect of probiotics on glycemic control and lipid profiles in patients with type 2 diabetes mellitus: a randomized, double blind, controlled trial.

  • 2024-09-16
  • Frontiers in endocrinology 15
    • Xuchao Peng
    • Hong Xian
    • Ning Ge
    • Lisha Hou
    • Tianjiao Tang
    • Dongmei Xie
    • Langli Gao
    • Jirong Yue

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 490
Population
adults aged 18 years and older, diagnosed with type 2 Diabetes Mellitus
Methods
Double-blind, placebo-controlled, randomized (1:1) clinical trial; intervention group received 25 ml probiotic beverage (≥10^8 CFU/mL Lactobacillus) four times daily; control group received equal volume of inactivated Lactobacillus
Blinding
Double-blind
Duration
16 weeks
Funding
Unclear
  • Large Human Trial

Introduction

This double-blind, placebo-controlled, randomized (1:1) clinical trial was conducted at the West China Hospital, Sichuan University, from March to September 2017.

Methods

Eligible participants included adults aged 18 years and older, living in the community, diagnosed with type 2 Diabetes Mellitus according to ADA guidelines, capable of self-managing their diabetes, and able to visit the study site for follow-up. The intervention group received 25 ml of a probiotic beverage containing with over 10^8 CFU/mL of Lactobacillus, administered four times daily. An equal volume of inactivated Lactobacillus was administered to the control group and the control group was administered the same volume of inactivated Lactobacillus. This study aimed to evaluate the effectiveness of probiotics on glycemic control and other diabetes-related outcomes in patients with type 2 diabetes patients. The primary outcomes were changes in HbA1c and FBG levels post-intervention. Investigators, participants, and study site personnel were blinded to the treatment allocation until the conclusion of the study. This double-blind, randomized, placebo-controlled clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR-POR-17010850).

Results

Of the 490 participants screened, 213 were randomized to either the probiotics group (n = 103) or the placebo group (n = 110). After 16 weeks of follow-up, the probiotic group showed reductions in HbA1c [-0.44 (-0.66 to -0.22)] and FBG [-0.97 (-1.49 to 0.46)] post-intervention, similar to the placebo group with reductions in HbA1c [-0.33 (-0.52 to -0.15)] and FBG [-0.90 (-1.32 to -0.47)], but these changes were not statistically significant in PP and ITT analyses (P>0.05). Adverse events were similarly distributed among groups, indicating comparable safety profiles.

Discussion

Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight.

Clinical trial registration

https://www.chictr.org.cn/showproj.html?proj=18421, identifier ChiCTR-POR-17010850.

Research Insights

  • Lactobacillus→Reduced Body Weight

    Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight.

    Effect
    Neutral
    Effect size
    Small
    Dose
    25 ml of a probiotic beverage containing over 10^8 CFU/mL, four times daily
  • Lactobacillus→Reduced Fasting Blood Glucose Levels

    FBG [-0.97 (-1.49 to 0.46)] post-intervention, similar to the placebo group with reductions ... but these changes were not statistically significant in PP and ITT analyses (P>0.05).

    Effect
    Neutral
    Effect size
    Small
    Dose
    25 ml of a probiotic beverage containing over 10^8 CFU/mL, four times daily
  • Lactobacillus→Reduced Hemoglobin A1c

    the probiotic group showed reductions in HbA1c [-0.44 (-0.66 to -0.22)] ... similar to the placebo group ... but these changes were not statistically significant in PP and ITT analyses (P>0.05).

    Effect
    Neutral
    Effect size
    Small
    Dose
    25 ml of a probiotic beverage containing over 10^8 CFU/mL, four times daily
  • Lactobacillus→Reduced Lipid Level

    Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight.

    Effect
    Neutral
    Effect size
    Small
    Dose
    25 ml of a probiotic beverage containing over 10^8 CFU/mL, four times daily

Adverse Events Reported

  • Lactobacillus→Overall tolerability

    Adverse events were similarly distributed among groups, indicating comparable safety profiles.

    Finding
    Reported
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