Insights
6 October 2022
Understanding the effect of ashwagandha root extract on stress, sleep and cognition
We caught up with Shefali Thanawala from Nutriventia Ltd who told us how CANTAB™ helped them to investigate the effects of Ashwagandha root extract on memory and focus in healthy, stressed adults.
About Nutriventia, Ltd.
Nutriventia Limited is the dietary supplements and food ingredients division of Inventia Healthcare Limited. Nutriventia delivers oral pharmaceutical products using Novel Drug Delivery Systems in India.
We at Nutriventia envision improving the overall health and wellness of the global community by developing and providing world-class nutraceutical ingredients in various formats. In partnership with Laila Nutraceuticals, we have developed Prolanza™: a sustained-release (SR) ingredient developed from standardized Ashwagandha root extract.
What was the rationale behind your study?
Stress today is a widespread, global phenomenon. From cognitive ability and sleep quality to overall physical and psychological well-being, it can adversely affect overall quality of life. Ashwagandha (Withania somnifera) is an important herb in the alternative medicine practice of Ayurveda, and has reported benefits in reducing stress and improving memory1.
Managing stress is of utmost importance, more so today than ever, to ensure a better quality of life. Ashwagandha is believed to reduce stress and support sleep2. We, therefore, conducted this study to evaluate the efficacy of our first-ever sustained-release formulation of Ashwagandha root extract (Prolanza™) on stress, cognition, overall mental well-being, and sleep.
This double-blind, randomized, placebo-controlled study evaluated the effect of Ashwagandha root extract sustained-release 300 mg capsule (Prolanza™) on cognitive function, stress levels, sleep quality, overall well-being, and safety in stressed subjects.
What methods did you use?
Subjects aged 20-55 years, having a Perceived Stress Scale (PSS) score of 14-24, were randomized to receive either one capsule of Nutriventia’s Prolanza™ or a placebo daily for 90 consecutive days.
The primary endpoint was to evaluate change in cognitive function as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB™) from baseline to the end of the study. The secondary endpoints included change in stress through the perceived stress scale (PSS-10), serum cortisol levels (measured between 9-11 am), the Oxford Happiness Questionnaire (OHQ), and Pittsburg sleep quality index (PSQI) from baseline to end of the treatment period.
What did you discover?
One hundred twenty-five (125) subjects completed the study.
At the end of the study, significant improvements were reported in recall memory (PAL First Attempt Memory Score (PALFAMS), p = 0.016268) and a significant reduction in the total error rate in recalling patterns (PAL Total Errors (Adjusted; PALTEA), p = 0.021464) in the Ashwagandha SR group as compared to the placebo group as assessed by the CANTAB™ Paired Associates Learning (PAL) assessment.
No adverse events were reported.
The study findings support the following:
1. Stress management support: the study showed significantly reduced serum cortisol levels, correlated with a reduction in overall anxiety levels in people who took Prolanza. This indicates that Prolanza may have a role in reducing stress.
2. Once daily dosing: A single daily dose of 300mg was effective due to the long-acting biological action and high bioavailability of Prolanza™.
3. Correlated with quality of life measures: Consumption of Prolanza™ 300mg capsules for 90 days was correlated with improved memory and focus, psychological well-being, sleep quality and reduced stress levels.
4. Safety: The study also indicated that Prolanza™ Ashwagandha SR capsules did not result in adverse events when administered for 90 days.
Why did you choose CANTAB™ for your study?
CANTAB™ makes the whole process of conducting cognitive assessments very convenient. As a recognized international gold standard for digital cognitive assessments and data collection, it tremendously improved the quality of the study.
A few reasons why we chose CANTAB™ for our study:
1. Accuracy: It includes highly sensitive, precise, and objective measures of cognitive function correlated to neural networks.
2. Trustworthiness: It has been published in 2,600 peer-reviewed papers.
3. Applicability: It is language-independent, culturally neutral, non-invasive, and requires no technical knowledge.
4. Validation: CANTAB™ tasks are the most validated and widely used computerized measures of cognition.
5. Convenience: It is suitable for researchers of all backgrounds
6. Recognition: It can be trusted given its reputation as an international gold standard in global pharmaceutical trials and academic research.
What are your plans for the future?
We plan to conduct more studies for Prolanza™ where we would like to use CANTAB™ to measure specific aspects of cognitive function in different therapeutic areas.
References
1. Dar NJ, MuzamilAhmad. Neurodegenerative diseases and Withania somnifera (L.): An update. J Ethnopharmacol. 2020 Jun 28;256:112769. doi: 10.1016/j.jep.2020.112769. Epub 2020 Mar 30. PMID: 32240781.
2. Cheah KL, Norhayati MN, Husniati Yaacob L, Abdul Rahman R. Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis. PLoS One. 2021 Sep 24;16(9):e0257843. doi: 10.1371/journal.pone.0257843. PMID: 34559859; PMCID: PMC8462692.
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