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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 80
Population
80 patients with MetS in Sina Clinic, Khoy, Iran
Methods
Double-blind clinical trial, randomized into ALE or placebo groups to receive either ALE (1800 mg/d as four tablets) or matching placebo for 12 weeks
Blinding
Double-blind
Duration
12 weeks
Funding
Unclear

Background

Transcription factor 7-like 2 (TCF7L2)-rs7903146 polymorphism is associated with increased risk of type 2 diabetes. The response of insulin and insulin resistance to artichoke leaf extract (ALE) may be affected by TCF7L2-rs7903146 polymorphism.

Objective

This study examined the effects of ALE supplementation on metabolic parameters of the TCF7L2-rs7903146 polymorphism in patients with metabolic syndrome (MetS).

Design, setting, participants and interventions

This double-blind clinical trial was conducted on 80 patients with MetS in Sina Clinic, Khoy, Iran. The patients were randomized into ALE or placebo groups to receive either ALE (1800 mg/d as four tablets) or matching placebo for 12 weeks.

Main outcome measures

Anthropometric indices, blood pressure, glucose and lipid profile levels were measured before and after the study. Moreover, patients were genotyped for TCF7L2 polymorphism.

Results

ALE supplementation decreased insulin level and the homeostasis model assessment of insulin resistance (HOMA-IR) in patients with the TT genotype of TCF7L2-rs7903146 polymorphism (P < 0.05). There was no significant interaction between blood pressure, glucose and lipid profile response to ALE supplementation.

Conclusion

The responses of insulin and HOMA-IR to ALE supplementation have shown an interaction with single-nucleotide polymorphism rs7903146 in TCF7L2.

Trial registration

Iranian Registry of Clinical Trial IRCT201409033320N9.

Research Insights

  • There was no significant interaction between blood pressure, glucose and lipid profile response to ALE supplementation.

    Effect
    Neutral
    Effect size
    Small
    Dose
    1800 mg/d as four tablets
  • ALE supplementation decreased insulin level and the homeostasis model assessment of insulin resistance (HOMA-IR) in patients with the TT genotype of TCF7L2-rs7903146 polymorphism (P < 0.05).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    1800 mg/d as four tablets
  • There was no significant interaction between blood pressure, glucose and lipid profile response to ALE supplementation.

    Effect
    Neutral
    Effect size
    Small
    Dose
    1800 mg/d as four tablets
  • There was no significant interaction between blood pressure, glucose and lipid profile response to ALE supplementation.

    Effect
    Neutral
    Effect size
    Small
    Dose
    1800 mg/d as four tablets
  • ALE supplementation decreased insulin level and the homeostasis model assessment of insulin resistance (HOMA-IR) in patients with the TT genotype of TCF7L2-rs7903146 polymorphism (P < 0.05).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    1800 mg/d as four tablets
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