Writing in Frontiers in Pharmacology, researchers from Canadian and U.S. institutions, including the Network of Applied Pharmacognosy, BC Institute of Technology (BCIT) and the Scientific Association for Botanical Education and Research, analyzed real-world data from U.S. adults using a full-spectrum kratom leaf extract designed to mimic traditional kratom tea.
At a 20 mg dose of the kratom alkaloid mitragynine, participants reported statistically significant improvements in focus, problem-solving, mental clarity and energy.
The 20 mg mitragynine-equivalent serving was selected to approximate doses associated with traditional kratom preparations, said Dr. Paula Brown, director of Applied Research, Natural Health and Food Products, BCIT and co-author of the study.
“This study confirmed that the serving size is an important consideration to achieve the positive benefits of natural kratom,” she added. “In general, many products out there are overly concentrated, have super-sized serving amounts, and could put consumers at risk. To achieve positive benefits, participants in this study only needed to take one serving of the Vivazen ingredient, as directed.”
Vivazen is a U.S. botanical wellness brand that offers shots, concentrates, capsules, gummies and seltzers with kratom as an ingredient.
“This study reflects Vivazen’s broader commitment to efficacy and integrity,” said Meghan DiMuzio, vice president, government affairs and communications, Levo Naturals, Vivazen’s parent company. “We hope this latest study will continue to build consumers’ confidence in our products as well as improve the overall understanding of how kratom can be safely consumed.”
Funding for the study came from the Canada Research Chairs Program and from the Scientific Association for Botanical Education and Research.
An entourage effect
Kratom is a tropical tree native to Southeast Asia whose leaves have been used for centuries for medicinal purposes. In that context, kratom leaves are chewed fresh or dried and consumed as tea from boiling leaves in water.
“Traditionally, kratom consumption was reported to increase work efficiency by improving physical stamina and alleviating aches and pains associated with physical labor,” the researchers wrote. “Though the consumption of kratom leaves continues in Southeast Asia today as a culturally accepted stimulant, recent surveys also report use to reduce dependence and side effects associated with opioid and methamphetamine use.”
In North America, kratom’s presence is not well documented though it is estimated there are 10 to 16 million U.S. kratom consumers who say consumption improves health and well-being and alleviates pain, increases energy and improves mood states.
A large proportion of American consumers also say they use kratom to reduce or abstain from over-the-counter and prescription medications because they find kratom’s safety and side effect more tolerable.
Findings indicate that kratom’s pharmacological profile may shift with dose. Low doses typically engage in non-opioid pathways associated with psychostimulant-like effect, and higher doses associated with the opioid receptor activity of analgesia and sedation, the scientists reported.
“Although best known for the action of mitragynine, kratom leaf offers an entourage effect of multiple relevant bioactive compounds that expand its properties in the body, including other chemical classes,” the researchers noted. “Although initially thought to be present in kratom leaf, it is now recognized that 7-HMG is an oxidative byproduct of mitragynine, observed in post-harvest kratom leaf at trace levels.”
The scientists explained that 7-HMG has gained recent attention as products have emerged that contain high levels of 7-HMG, achievable only by synthetic means. Concentrated 7-HMG products have proliferated the U.S. marketplace and in contrast to traditional kratom preparations are reported to have significantly different dose effects.
“These products are often mislabeled as kratom, may contain other unidentified constituents not found in kratom leaf and pose a significant risk to public health,” the researchers wrote.
Study details
Participants were recruited through social media platforms, podcast advertisements and email listservs targeting health and wellness audiences. The investigation sought to understand the effects of proprietary full spectrum leaf extract, designed to mimic traditional kratom tea.
The real-world observational study through a third-party health and wellness data software company (MoreBetter Ltd.) provided anonymized data to the researchers, though it was a small-scale investigation.
“This study design and its outcomes affirm a global trend: highly meaningful efficacy and safety data can be amassed outside the established scope of clinical trial designs with superior capture of demographic intricacies, and alongside with significant cost savings,” said Dr. Thomas Brendler, PhD, adjunct assistant professor, Pharmacognosy Institute, Retzky College of Pharmacy, University of Illinois Chicago, who was not affiliated with the study. “In fact, a growing number of service providers offer real world data collection and evaluation as part of their portfolio on an international scale.”
Each evening, participants received a survey prompt via text message and email and submitted responses via a structured questionnaire.
Participants reported focus and energy effects after consuming 20 mg of various consumption patterns over a two-week period and showed significant improvement in outcomes for focus and productivity as well as a decrease in average pain and perceived pain. The most common side effect was headache and documented in less than 5% of reported sessions.
A higher consumption group took 20 to 40 mg mitragynine equivalent.
Reports from the higher consumption group showed an increase in prevalence of side effects with 24% saying they experienced an onset of fatigue, sedation and changes in appetite, the researchers explained.
“These findings are consistent with the known dose-dependent pharmacology of mitragynine, whereby higher doses appear to increase activity at the opioid system, producing effects like fatigue and sedation,” they wrote.
They added that the specific threshold between what constitutes a low and a high dose is not clear, however the use of ethnobotanical knowledge can guide toward traditional doses to achieve desired effects.
Source: Frontiers in Pharmacology. doi: 10.3389/fphar.2026.1838148. “Observational real-world analysis of dose-dependent effects of Mitragyna speciosa (Korth.) on focus and energy.” Authors: C. Miyabe Shields et al.
