Shinde S et al.

ACS Omega. 27 Oct 2023. doi: 10.1021/acsomega.3c03491

The presence of phytochemical bioactive compounds such as withanolides, with-anosides, alkaloids, flavonoids, and phenolic compounds has an important role in the therapeutic and nutritional properties of WS. Thus, the choice of WS plant part and extraction solvents, with conventional and modern techniques, plays a role in establishing WS as a potential nutraceutical product.

Patel SB et al.

J Ayurveda Integrate Med. 2016 Mar. 7(1): 30-37. doi: 10.1016/j.jaim.2015.08.001

The no observed adverse effect level (NOAEL) of Withania somnifera extract (4.5% withaferin A; total withanolides greater than 10%) is 2000mg/kg body weight, the highest level tested, which confirms the safety of 1.5% total withanolides root extract.

Smith SJ et al.

J Psychopharmacol. 2023 Sept 23. 0(0). doi: 10.1177/02698811231200023

In a randomized, double-blind, parallel-group, placebo-controlled study, 120 healthy (overweight/mildly obese) adults (body mass index between 25 and 35 kg/m2) experiencing high stress and low energy are randomly assigned into one of two groups comprising either a twice-daily intake of capsules containing a Withania somnifera (Witholytin®) extract (200mg) or a placebo for 12 weeks. Changes in stress, fatigue, quality of life, and interest in sexual activity, as well as oxidative stress, inflammation, and blood glucose are assessed.

O’Conner J et al.

2022 Dec. J Med Food. 25(12): 1086-1094. doi: 10.1089/jmf.2022.0040

Witholytin® was administered (350mg) twice daily for 30 days to 60 healthy students 18-50 years old. In these two double-blind, placebo controlled trials, Witholytin® showed positive improvements to stress, cognitive function, quality of sleep, and overall wellbeing with participants indicating an increased ability to adapt and manage stress, while delayed onset of restful and restorative sleep began between days 9 and 13, both supporting adaptogenic properties associated with ashwagandha.

Baker C et al.

J Med Food. 2022 Dec. 25(12): 1095-1101. doi: 10.1089/jmf.2022.0042

Witholytin® was administered (350mg) twice daily for 30 days to 60 healthy students 18-50 years old. In these two double-blind, placebo controlled trials, Witholytin® showed positive improvements to stress, cognitive function, quality of sleep, and overall wellbeing with participants indicating an increased ability to adapt and manage stress, while delayed onset of restful and restorative sleep began between days 9 and 13, both supporting adaptogenic properties associated with ashwagandha.

Modi SJ et al.

Molecules. 22 Feb 2022. 27: 1476. doi: 10.3390/molecules27051476

The validated UHPLC-MS/MS bioanalytical method was applied simultaneously to estimate seven constituents after single-dose oral administration of WSE (Withania somnifera extract; 500 mg/kg) (n = 6) [in vivo pharmacokinetic study]. The molecular descriptors of the different WSE constituents were evaluated for Lipinski’s rule of five, and all mentioned phytoconstituents have a molecular weight in the range of 200-500 Da except for two molecules, i.e., withanoside IV (WSIV ) and withanoside V (WSV). Further, all constituents of WSE (WSIV, WSV, withaferin A (WFA), 12-deoxywithastramonolide (WSL), withanone (WNO), withanolide A (WLA), withanolide B (WLB)) are able to absorb from the human intestinal membrane except WSIV and WSV, the rest of the constituents could cross BBB [in silico ADMET prediction (unpublished internal report)]. WFA and WSL have maximum bioavailability in systemic circulation which was also supported by in vivo pharmacokinetic study.

Girme A et al.

ACS Omega. 2020. 5: 27933-27943. doi: 10.1021/acsomega.0c03266

Published in-house methodology identifies the withanolides being analyzed by Verdure as well as how total withanolide content is determined / assessed. This allows for transparent, repeatable methodology disclosure.

Saste G et al.

2019 Sept 6-12. Poster presentation at AOAC International 133rd Annual Meeting & Exposition in Denver, CO, USA.