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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 43
Population
Participants (n = 43)
Methods
parallel randomized, double-blind, placebo-controlled clinical trial; 100 mg of vitamin B1 and 100 mg of vitamin B2 or placebo
Blinding
Double-blind
Duration
four weeks
  • Rigorous Journal
Background: Anxiety, stress, and sleep disturbances significantly affect overall health. Research suggests that vitamins B1 and B2 may play a role in mood regulation and neuroprotection. This study aimed to investigate the effects of vitamin B1 and B2 supplementation in alleviating anxiety and stress and improving sleep quality. Methods: This study was a parallel randomized, double-blind, placebo-controlled clinical trial. Participants (n = 43) were randomized to receive one of the following two interventions: 100 mg of vitamin B1 and 100 mg of vitamin B2 or placebo. Intervention outcomes were assessed at baseline and week four, including SAS (Self-Rating Anxiety Scale), PSS (Perceived Stress Scale), PSQI (Sleep Quality Index), ESS (Sleepiness Scale), and measurement of urinary vitamin B1 and B2 levels. Results: After four weeks, urinary vitamin B1 levels increased from 158 ± 108.9 ng to 1333.1 ± 1204.5 ng (p < 0.01), and urinary vitamin B2 levels increased from 308.0 ± 198.3 ng to 6123.2 ± 4847.2 ng in the supplement group (p < 0.01). The PSS scores decreased significantly in the supplement group from 21.5 ± 4.1 to 15.5 ± 4.5 (p < 0.05), while the placebo group showed a change from 20.3 ± 4.3 to 19.8 ± 5.5. Vitamins B1 and B2 did not have a significant effect on anxiety improvement (p > 0.05). The PSQI scores decreased in the supplement group from 8.0 ± 3.12 to 6.3 ± 2.0 (p < 0.05), while the placebo group worsened from 5.7 ± 2.7 to 7.4 ± 2.9. Meanwhile, the ESS scores in the supplement group decreased from 13.0 ± 3.4 to 9.1 ± 3.9 (p < 0.05), demonstrating a significant improvement compared to the placebo group. Conclusions: The clinical trial findings demonstrated that while vitamin B1 and B2 supplements helped reduce stress, enhance sleep, and reduce sleepiness, they had no discernible impact on reducing anxiety. Future studies should focus on the long-term effects of vitamin B1 and B2 supplements, exploring the combined effects of combined vitamin B1 and B2 medications for the treatment of stress and sleep disorders.

Research Insights

  • The PSQI scores decreased in the supplement group from 8.0 ± 3.12 to 6.3 ± 2.0 (p < 0.05), while the placebo group worsened from 5.7 ± 2.7 to 7.4 ± 2.9.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 mg/day
  • The PSS scores decreased significantly in the supplement group from 21.5 ± 4.1 to 15.5 ± 4.5 (p < 0.05), while the placebo group showed a change from 20.3 ± 4.3 to 19.8 ± 5.5.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 mg/day
  • The PSQI scores decreased in the supplement group from 8.0 ± 3.12 to 6.3 ± 2.0 (p < 0.05), while the placebo group worsened from 5.7 ± 2.7 to 7.4 ± 2.9.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 mg/day
  • The PSS scores decreased significantly in the supplement group from 21.5 ± 4.1 to 15.5 ± 4.5 (p < 0.05), while the placebo group showed a change from 20.3 ± 4.3 to 19.8 ± 5.5.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    100 mg/day
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