The trial, conducted on the brand's Thrive supplement, found that perceived stress, anxiety and happiness improved among participants.
The trial conducted by Citruslabs assessed 38 women between the ages of 25 and 50 with lasting concerns around energy, fatigue and brain fog through an open label, single-arm, eight-week trial with clinically-validated questions.
The results demonstrated an improvement across the three clinically-used questionnaires for happiness, stress and anxiety, with a 50% improvement on the Generalized Anxiety Disorder 7 screening and a 66% improvement on the Oxford happiness scale from week 4 to 8. Improvements were observed as early as the first trial check-in point, which is halfway through the trial.
Key Findings
- Results demonstrated an improvement across all three clinically-used questionnaires for happiness, stress and anxiety
- Seventy percent of respondents stated they "felt more like themselves”
- Seventy-five percent of respondents were less overwhelmed by day-to-day stressors
- Seventy-three percent of respondents stated they were more able to cope with everyday life
- Seventy-eight percent of respondents stated mood improvement
- There was a 70% increase in libido across participants and a 63% improvement in brain fog
- Seventy-five percent of participants reported a 73% improvement in fatigue and energy.
- Over 80% of the respondents wanted to keep taking Thrive and 86% would recommend Thrive to a friend or family member
"The finding that was the most impressive was the 50% improvement in GAD-7 scores (clinical assessment for generalized anxiety)," said Dr. Thara Vayali, hey freya co-founder and chief medical officer. "Our trial, which was run externally, used clinically-validated questionnaires to represent meaningful changes over time. Many supplement trials use perception scores only. This may be because the symptoms they are addressing don’t have a clinical equivalent, and self-perception is the best way to show change. However, because stress management intersects with mental health, we had the ability to incorporate existing clinical scoring tools, and we saw excellent outcomes.
“The most reassuring finding to me was that all scores regarding fatigue, overwhelm, ability to cope with stressors, and energy, continued to improve over the eight weeks in about 75% of participants, which is what I expected. We know that stress support is not the solution for all women, and this was a realistic number based on my experience."
Ingredient selection
Vayali added that the company formulates its products specifically for women by leveraging scientific evidence rooted in naturopathic medicine and herbalism.
"I combined my clinical knowledge with the latest evidence on herbs and nutrients for stress management," she said. "My background as a nutritionist, herbalist and naturopathic physician allowed me to ensure safe and effective doses of each of the 20 ingredients in the formula. Supplements for stress management should contain so much more than magnesium and ashwagandha, it’s about balancing and replenishing critical fat-soluble and anti-inflammatory nutrients, methyl donors, and having a blend of supportive, calming and rejuvenating herbs.”
While the formulation does indeed include magnesium and ashwagandha, it also features letter vitamins and minerals, as well as omega-3 from algae, rhodiola, green tea, lavender extract and more.
Vayali said the formulation was based on over a decade of treating hormonal concerns in women along with the best available research on these conditions for herbs, vitamins and minerals. Her goal was to ensure that the formula included the five issues that are commonly found in women: thyroid, adrenals, cognition, menstrual symptoms and mood. Additionally, she wanted to make sure to address the clinical evidence showing vitamin and mineral deficiencies found in women, particularly mothers.
Susanne Mitschke, CEO and co-founder at Citruslabs, said more women are recognizing the benefits of targeted solutions while companies are seizing the opportunity.
"It's an agenda that women are pushing, and we are now getting our voices heard, and that is a really good thing," Mitschke said during a 2023 NutraCast episode. "And this is why we're getting more funding in women's health but also because I think that the whole wellness industry really made this happen because now we have supplements and even though they are not drugs, they do help women with their symptoms. And I think this is a really great step in the right direction.”
Anxiety-free marketing
When it comes to marketing products like Thrive, Vayali said she wants to make it clear that hey freya is not marketing Thrive as an anti-anxiety dietary supplement.
"Thrive is formulated to focus on stress management and the pillars that make up women’s health," she said. "What we are happy to share is that the reported improvements are equivalent to what is considered successful treatment for first line anti-anxiety treatments, commonly SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Norepinephrine Reuptake Inhibitors).
“From a clinical management perspective, if a patient that has been diagnosed with an anxiety disorder has 50% improvement in their anxiety scores (one commonly used assessment is the GAD-7) after eight weeks while taking SSRI/SNRIs, this is considered a full and effective response. We are not suggesting that Thrive is an anti-anxiety supplement that could be used instead of anti-anxiety medications. None of the women in the trial had an anxiety diagnosis, they had scores on the GAD-7 indicative of mild to moderate anxious symptoms. Our Thrive supplement had a 50% improvement in these scores. What our equivalent results emphasize is the role that the stress response has in managing anxious symptoms. When we comprehensively assist women’s stress response, we see improvements in the severity of anxious symptoms."