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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 68
Population
68 patients with migraine
Methods
Randomized controlled trial, 20 g/d of either flaxseed powder (intervention) or roasted wheat powder (control) for 8 wk
Duration
8 wk

Background

Migraine is a prevalent neurologic disorder that is linked to neuroinflammation. Flaxseed is a plant source of omega-3 (n‒3) fatty acids, which may display anti-inflammatory effects through conversion to long-chain ω-3 fatty acids with known anti-inflammatory potential.

Objectives

We examined the effect of flaxseed supplementation on headache characteristics and psychosocial well-being in patients with migraine.

Methods

This randomized controlled trial was conducted on 68 patients with migraine. Participants consumed 20 g/d of either flaxseed powder (intervention) or roasted wheat powder (control) for 8 wk. Primary outcomes included: headache frequency, duration, and severity. Secondary outcomes were psychological states (depression, anxiety, and stress), quality of life, sleep quality, weight, and blood pressure. Data were analyzed using SPSS.

Results

At the end of the 8-wk intervention, the flaxseed group showed significant improvements in headache severity (‒5.0 ± 2.2 compared with ‒1.0 ± 1.9, P < 0.001), headache impact score (quality of life) (‒15.7 ± 11.0 compared with ‒2.3 ± 8.1, P < 0.001), and insomnia severity index (‒4.6 ± 6.5 compared with ‒1.6 ± 4.9, P = 0.029) compared with the control group. Changes in headache frequency or duration, as well as other measurements, were not significant between groups. Per-protocol and intention-to-treat analyses yielded identical results.

Conclusions

Daily consumption of flaxseed for 8 wk may improve headache severity, sleep quality, and quality of life in patients with migraine. Further research is warranted to confirm these findings and explore underlying mechanisms.

Research Insights

  • headache impact score (quality of life) (‒15.7 ± 11.0 compared with ‒2.3 ± 8.1, P < 0.001)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    20 g/d
  • insomnia severity index (‒4.6 ± 6.5 compared with ‒1.6 ± 4.9, P = 0.029)

    Effect
    Beneficial
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d
  • the flaxseed group showed significant improvements in headache severity (‒5.0 ± 2.2 compared with ‒1.0 ± 1.9, P < 0.001)

    Effect
    Beneficial
    Effect size
    Large
    Dose
    20 g/d
  • Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    20 g/d

Adverse Events Reported

  • flaxseedOverall tolerability

    Changes in headache frequency or duration, as well as other measurements, were not significant between groups.

    Finding
    No significant difference
    Significant
    No
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