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Efficacy and safety of fermented garlic extract on hepatic function in adults with elevated serum gamma-glutamyl transpeptidase levels: a double-blind, randomized, placebo-controlled trial.

  • 2016-10-14
  • European journal of nutrition 56(5)
    • Ha-Na Kim
    • Sung-Goo Kang
    • Yong Kyun Roh
    • Min-Kyu Choi
    • Sang-Wook Song

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 39
Population
75 adults with elevated serum gamma-glutamyl transpeptidase (GGT) levels
Methods
Double-blind, randomized, placebo-controlled study, two sachets/day containing fermented garlic extracts or placebo for 12 weeks
Blinding
Double-blind
Duration
12 weeks
Funding
Unclear
  • Rigorous Journal

Purpose

Alcoholic liver disease or non-alcoholic fatty liver disease/non-alcoholic steatohepatitis are well-known risk factors for liver fibrosis or cirrhosis and hepatocellular carcinoma; it is a major global health concern, but there are few effective and safe management options. Therefore, we aimed to investigate the effects of fermented garlic extracts (FGEs) on hepatic function in adults with mild hepatic dysfunction without underlying hepatic disease.

Methods

In this double-blind, randomized, placebo-controlled study, seventy-five adults with elevated serum gamma-glutamyl transpeptidase (GGT) levels were included in a FGE-administered group (n = 36) or a placebo group (n = 39), and received either two sachets/day containing FGEs or placebo over a 12-week period. Primary endpoint was the change in serum GGT levels. Data were analysed using a generalized linear mixed effects model.

Results

Significant group × time interactions for serum levels of GGT (F = 3.98, P = 0.022) and alanine aminotransferase (ALT; F = 3.28, P = 0.043) were observed with an improvement in levels of GGT (P = 0.066) and ALT (P = 0.014) in the FGE group compared to that reported for the placebo group at the 12-week visits. There was no intergroup difference in the prevalence of adverse events.

Conclusions

Intake of FGEs improved serum GGT and ALT levels in adults with mildly elevated serum GGT level without reported adverse side effects. FGEs might be effective and safe management options for mild hepatic dysfunction.

Research Insights

  • black garlic→Reduced Alanine Aminotransferase Level

    Significant group × time interactions for serum levels of … alanine aminotransferase (ALT; F = 3.28, P = 0.043) were observed with an improvement in levels of … ALT (P = 0.014) in the FGE group compared to that reported for the placebo group at the 12-week visits.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    two sachets/day containing FGEs
  • black garlic→Reduced Gamma-Glutamyl Transpeptidase Level

    Significant group × time interactions for serum levels of GGT (F = 3.98, P = 0.022) … with an improvement in levels of GGT (P = 0.066) in the FGE group compared to that reported for the placebo group at the 12-week visits.

    Effect
    Neutral
    Effect size
    Small
    Dose
    two sachets/day containing FGEs

Adverse Events Reported

  • black garlic→Overall tolerability

    There was no intergroup difference in the prevalence of adverse events.

    Finding
    No significant difference
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