Effects of Withania somnifera Extract in Chronically Stressed Adults: A Randomized Controlled Trial – PubMed Black Hawk Supplements

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CONCLUSIONS: Our findings demonstrate the stress-reduction capabilities of this well-characterized aqueous extract of WS (root and leaf) at the low dose of 125 mg/day, in a dose-dependent manner, via the modulation of the HPA axis.
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Effects of Withania somnifera Extract in Chronically Stressed Adults: A Randomized Controlled Trial - PubMed

Randomized Controlled Trial

. 2024 Apr 26;16(9):1293.

doi: 10.3390/nu16091293.

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Randomized Controlled Trial

Effects of Withania somnifera Extract in Chronically Stressed Adults: A Randomized Controlled Trial

Srikanta Pandit et al. Nutrients. .

Abstract

Background: Stress is a known causative factor in modulating cognitive health, which overall well-being and quality of life are dependent on. Long-term stress has been shown to disrupt the balance of the hypothalamic-pituitary-adrenal (HPA) axis. Adaptogens, such as Withania somnifera (ashwagandha), are commonly used in Ayurvedic medicine for stress relief and ameliorating HPA-axis dysfunction. The aim of this study was to support the role of a root and leaf water-extracted ashwagandha extract (WS) in stress reduction by confirming the lowest clinically validated dose for stress management (125 mg/day) in a dose-dependent clinical study in adults with self-reported high stress.

Methods: An 8-week, randomized, double-blinded, placebo-controlled study to compare the effects of three different WS extract doses (125, 250 and 500 mg) was performed. A total of 131 adults were enrolled, and 98 were included in the final analysis. Attenuation of chronic stress was measured using the 14-item Perceived Stress Scale (PSS) and biochemical-related stress parameters.

Results: We have shown that aqueous WS extract (roots and leaves) safely reduces mild to moderate chronic stress at doses of 125 mg, 250 mg, and 500 mg/day for 8 weeks.

Conclusions: Our findings demonstrate the stress-reduction capabilities of this well-characterized aqueous extract of WS (root and leaf) at the low dose of 125 mg/day, in a dose-dependent manner, via the modulation of the HPA axis.

Trial registration: This study was registered with the Clinical Trials Registry-India (CTRI) with the registration number: CTRI/2019/11/022100.

Keywords: Withania somnifera; ashwagandha; perceived stress scale (PSS).

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1

Participant disposition (CONSORT diagram).

Figure 2
Figure 2

Scatter plots and slopes of PSS, HAM-A, HAM-D, and stress-related biochemical parameters among the subjects included in the per-protocol analysis consuming the placebo (blue dots and lines), WS 125 mg/d (red dots and lines), WS 250 mg/d (green dots and lines) and WS 500 mg/d (brown dots and lunes) from baseline to 8 weeks. In the table, values are the slope coefficient (SE). Model 1 compares all treatment groups versus the placebo group (reference). Model 2 compares three treatment groups, 125 mg, and 250 mg (reference). All models were adjusted for sex, age, BMI, and the corresponding baseline measure. * p < 0.05, ** p <0.01, *** p <0.001.

Figure 2
Figure 2

Scatter plots and slopes of PSS, HAM-A, HAM-D, and stress-related biochemical parameters among the subjects included in the per-protocol analysis consuming the placebo (blue dots and lines), WS 125 mg/d (red dots and lines), WS 250 mg/d (green dots and lines) and WS 500 mg/d (brown dots and lunes) from baseline to 8 weeks. In the table, values are the slope coefficient (SE). Model 1 compares all treatment groups versus the placebo group (reference). Model 2 compares three treatment groups, 125 mg, and 250 mg (reference). All models were adjusted for sex, age, BMI, and the corresponding baseline measure. * p < 0.05, ** p <0.01, *** p <0.001.

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Effects of Withania somnifera Extract in Chronically Stressed Adults: A Randomized Controlled Trial – PubMed