Decentralized Excellence: People Science and Phylos Bioscience Show that THCV Improves Energy and Wellbeing with Minimal Side Effects

The Chloe Platform Facilitates End-to-End Participant Engagement — Speeding Data Collection, Engaging Participants, and Delivering Key Scientific Evidence

Trial Overview

Type of Study: Double-blind, placebo-controlled, randomized, decentralized trial approved by the Advarra Institutional Review Board (IRB).

  • Goal: Evaluated the impact of Phylos’ combined THCV+THC gummy on energy, focus, and subjective exercise performance while differentiating from standard THC and placebo gummies.

  • Participant Criteria: Healthy adults aged 21+ in the Los Angeles, California, area.

  • Recruitment: Targeted diverse participant pool through Phylos' mailing list and digital ads.

  • Trial Structure: Participants consumed nine gummies (three THCV+THC, three THC-only, three placebos) on a randomized schedule, logging outcomes via the Chloe app.

  • Timeline: 12 week trial period.

  • Analytical Methods: General Linear Models to evaluate treatment effects, controlling for individual variation, complemented by non-parametric tests.

  • Key Results: Scientific evidence that THCV+THC improves subjective motivation, energy, well-being and activity compared to placebo, while reducing the fatigue and hunger side effects of traditional THC products.

Introduction

The cannabinoid research landscape is rapidly advancing. THC and CBD have long dominated the field, but attention is shifting toward rare cannabinoids with distinct physiological effects, tetrahydrocannabivarin (THCV). Tetrahydrocannabivarin (THCV), a non-psychoactive variant of tetrahydrocannabinol (THC), presents a promising wellness alternative to THC-only products and traditional medicines. However, clinical evidence is limited, as are descriptions of real-world differences from impacts of THCV. Though present only in trace amounts in traditional cannabis strains, THCV and other rare cannabinoids show promise in the treatment of inflammation, anxiety and metabolic disorders.

Phylos Bioscience, a leader in cannabis genetics, embarked on an innovative journey to validate the efficacy of its THCV+THC gummy, purported to improve energy and sharpen focus while minimizing the fatigue and hunger associated with THC.

To generate gold-standard scientific evidence, bolster its marketing claims and differentiate its product from conventional THC offerings, Phylos partnered with People Science, specialists in technology-enabled decentralized clinical trials. This collaboration gathered concrete scientific evidence for THCV's impact on subjective focus, energy, and activity to position the gummy as a preferred choice in the cannabis market.

Execution & Data Collection

To execute a decentralized, double-blind, placebo-controlled study, People Science utilized its proprietary Consumer Health Learning & Organizing Ecosystem (Chloe). Chloe combines a mobile app with a health research platform designed for companies that prioritize scientific rigor, enabling rapid and cost-effective validation of product claims through evidence-based methods.

Decentralized Clinical Trials (DCTs) evaluate the impact of novel interventions without the need for in-person doctor’s visits. By combining a mobile app for communication, consent, data entry and visualization, a software backend for clinical operations and a team to manage shipments - all the work of participating in a clinical trial can be done from home. This strategy is speeding every stage of scientific advancement, from cost reduction to study design, recruitment, data collection, monitoring, and data visualization.

The Phylos study targeted healthy people aged 21 and older. The recruitment strategy aimed to evaluate efficacy in the target user-base without imposing strict demographic quotas, resulting in a varied participant pool (71 participants, 61% regular cannabis users, 53% female, 40% Caucasian, 30% Latino, 8% African American, 8% Asian, 14% other ethnicities).

The study spanned 12 weeks, during which participants were asked to consume nine gummies in a randomized order: blocks of three THCV+THC, three THC-only, and three placebo. Participants chose three days per block for consumption and used the Chloe app to log their subjective experiences, including energy levels, focus, exercise performance, appetite, and any side effects. The double-blind design ensured that neither the participants nor the researchers knew which type of gummy was consumed in a given block, enhancing the scientific integrity of the study. Results were published in a poster at ICRS (International Cannabinoid Research Society) in 2024.

Study Design: Double-blind, placebo-controlled, double crossover trial (ClinicalTrials.gov ID NCT06213064).

Treatments: placebo, THCV+THC (6.5 mg THCV, 3.4 mg THC), or THC (5 mg THC) gummy; all gummies were red in color and had watermelon flavoring. ∙ Participants took each treatment type 3 days in a one-week period, then crossed over into another treatment arm.

Leveraging the Chloe Platform: The Chloe platform played a key role in the Phylos trial, offering a comprehensive solution for decentralized data collection and participant engagement. More than just an app, it simplified every phase of the trial from study design to data capture, reducing logistical challenges for both the trial sponsor and participants.

What is Chloe?

Chloe consists of two key components:

Web Platform for Trial Design and Execution: Chloe’s web platform supports complete trial management, including custom data collection from surveys, wearables, and labs. Fully HIPAA-compliant and FDA audit-ready, the platform streamlines processes such as screening, consent, compliance tracking, and reporting.

Mobile Application for Participant Use:

The Chloe app enables participants to easily join trials, offering tools for data collection, scheduling, messaging, and compensation. It ensures consistent data logging with prompts, provides early access to results, and features personalized data visualizations and communications, which keeps participants engaged.

Benefits to Phylos

Efficient Decentralized Data Collection: Seamless remote participation, reducing logistical barriers and costs associated with in-person visits.

Real-Time Monitoring and Feedback: Provided instant insights into participant data, allowing timely adjustments to maximize study effectiveness.

High Data Accuracy: Structured prompts and reminders helped maintain high data quality and participant adherence throughout the trial.

Benefits to Trial Participants

  • Convenient Home-Based Participation: Allowed participants to track their experiences with the THCV+THC gummies from home, enhancing accessibility.

  • Personalized Data Insights: Real-time feedback on individual progress, making the study experience more engaging.

  • Clear Results Sharing: Provided personal and group-wide data reports after the study, empowering participants with knowledge of the outcomes.

  • High Satisfaction and Retention: The platform's usability scored 4.5/5, with 98% of participants satisfied, willing to join future studies, and likely to recommend Chloe to their peers.

Outcomes

The collaboration demonstrated significant improvement in participant symptoms and quality of life with reduced side-effects compared to THC, establishing a benchmark for decentralized cannabinoid trials:

  • Clinical Validation: The study showed that a 2:1 THCV+THC gummy enhanced energy, well-being, and subjective athletic performance in participants with just one-third the rate of fatigue seen with THC alone, supporting Phylos’ marketing claims and guiding future product development. Impacts were greatest in regular cannabis users.

  • Decentralized Trial Efficiency: Utilizing the Chloe app minimized logistical challenges and improved participant engagement, setting a flexible model for future research.

  • Comprehensive Data for Dissemination: The trial was presented at the International Cannabinoid Research Society and is in preparation for scientific publication, as well as in collaborative blogs and interviews with People Science.

  • Effective Execution: Completed the trial over a 12-week period. The project demonstrated People Science's full-service support capabilities, from study design to data analysis.

Key Findings

Enhanced Motivation, Energy, Wellbeing and Activity: were increased significantly compared to placebo.

  • Fewer Side Effects: 86% of participants taking THCV+THC experienced no side effects.

  • Reduced Fatigue: The THCV+THC gummy resulted in three times fewer reports of fatigue compared to the THC-only gummy.

  • Stable Appetite: The THCV+THC gummy did not cause a significant increase in hunger—unlike the THC-only gummy which led to a 50% rise in hunger—highlighting its ability to counteract the appetite-stimulating effects of traditional cannabinoids.

  • Positive Trial Experience: 98% of participants reported a positive experience with the study, with high satisfaction using the Chloe app.

  • Increased Daily Enjoyment: 40% more participants enjoyed their daily activities after taking the THCV+THC gummy compared to the placebo.

  • Participants reported adverse events (AE) the day after taking a gummy.

  • Participants were asked if they felt Fatigue, had Dry Mouth/Eyes, had a Headache, had NO Negative Effects, or were given the option of selecting “Other”.

  • Fisher’s Exact Tests were used to detect differences between treatments for reports of each AE.

  • Adverse events from all participants were used in analysis.

Business Impact

The trial bolstered Phylos’ market credibility by providing scientific validation for the benefits of the THCV+THC gummy, enhancing consumer trust and brand reputation.

The scientific findings from the trial provided Phylos with the validation needed to launch a new business line, Natural Natural. This consumer-facing ingredient brand commercializes Phylos' patented, naturally-derived rare cannabinoid genetics, offering science-backed, plant-based wellness products. Leveraging its proven effects, Natural Natural has partnered with leading growers, extractors, and brands to ensure the highest quality standards, expanding its reach across North America and setting the stage for further growth.

Findings garnered media attention, were presented at scientific conferences, and are in preparation for peer-reviewed publication, positioning Phylos as an industry innovator. Following the trial’s success, Phylos plans to expand research and explore additional product lines.

  • “We were able to design and execute a successful decentralized trial supporting Phylos’ product development, while empowering participants to learn with their own data.”

    Azure Grant, PhD, Lead Scientist at People Science

  • “This was a delightful experience. Thank you for showing me an alternative to consuming edibles that help you tremendously. Especially when the help comes from studies.”

    Participant

  • “The study allows us to leverage our exceptional plants in the advancement of targeted cannabis products, and to chart new territories in understanding the efficacy of natural cannabinoids.”

    Alisha Holloway, PhD, Chief Scientific Officer at Phylos

  • “Appreciate that research is being done on this topic. Long over due.”

    Participant