MDBio finds health benefits of CBD and botanical supplement for sleep support in clinical trial

06 Nov 2023 --- In a four-week clinical trial, study participants consuming MDBio’s sleep supplement observed significantly improved sleep quality — as they reported fewer sleep disturbances — anxiety, stress and well-being compared to a placebo group. The supplement, MDsleep + hemp, contains a mix of cannabinoids, herbs and botanicals. 

“MDsleep contains cannabidiol (CBD), cannabinol (CBN), delta-9 tetrahydrocannabinol (THC), valerian, chamomile, hops, gamma-aminobutyric acid (GABA) and L-theanine, which work synergistically to support sleep,” Brenden Dougherty, CEO at MDBio, tells Nutrition Insight. 

“MDsleep does not contain any melatonin. Research shows that melatonin can lead to unpleasant side effects like next-day drowsiness, headaches, dizziness and nausea when used long-term or at high doses. By not including melatonin, MDsleep avoids these potential issues.” 

The clinical trial tested two formulas of MDsleep against a placebo. Although they contain similar amounts of CBD, CBN and L-theanine, the product MDsleep + hemp — found to be most effective — held lower amounts of THC and higher levels of GABA, hops and valerian oil. 

While the researchers found significant differences in health outcomes for participants using MDsleep + hemp, there were no significant differences in health parameters for participants consuming the other version of MDsleep. 

Natural sleep aids 
Dougherty notes a growing consumer demand for effective, natural sleep aids as an alternative to prescription sleep medications that can be habit-forming. 

“MDsleep is positioned as a safe, non-habit forming sleep support supplement to meet this need. The clinical trials validating MDsleep’s efficacy and safety differentiate it from the many unproven products in the market.” 

MDsleep supplements contain a mix of cannabinoids, herbs and botanicals (Image credit: MDBio).The researchers conclude: “We observed that a botanical blend containing lower amounts of THC and higher amounts of GABA, hops oil and valerian oil significantly improved sleep quality, anxiety, stress and overall well-being in healthy individuals with a desire for better sleep.” 

Moreover, they add that the active products demonstrated a favorable safety profile, as all side effects were mild or moderate, and there were no significant differences in the frequency of reported side effects between the group consuming supplements with active ingredients and the control group. 

However, as they did not examine the individual effects of all ingredients in the two MDsleep formulas used, the researchers noted they could not determine which were the main drivers of the different impacts on health outcomes. 

The researchers suggest that lower amounts of THC may be more effective at promoting sleep, based on an earlier study where participants using cannabis for its sleeping effects preferred strains with lower THC levels. 

Additionally, they suggest that the higher levels of GABA, hops and valerian oil could contribute to the product’s effectiveness, as these are known as positive modulators of GABA, a neurotransmitter associated with promoting sleep and inducing mild sedation. 

Earlier research found that sleep quality improves when CBD is combined with melatonin. 

Research set up 
In the study, published in Nutrients, 620 participants looking to sleep better were randomly assigned to three study products — two versions of MDsleep and a placebo. They received a four-week supply of their study product in the mail, along with instructions for study participation. 

Participants took one softgel 30 minutes before bedtime and could take up to a maximum of four softgels per day as needed throughout the study. They were directed to wait five days before increasing the number of softgels. The actual number consumed was recorded. 

At baseline, participants completed health outcome assessments of their sleep, feelings of anxiety, stress, pain and overall well-being. At this time, 90% of participants reported that they suffered from stress, while 76% suffered from sleep disturbances mainly, with 63.6% stating they had mild or moderate sleep disturbances. 

Participants also completed weekly health surveys assessing the same indicators. Moreover, they recorded side effects and were encouraged to contact the researchers if they experienced those. 

In the clinical trial, participants using MDsleep + hemp significantly improved sleep quality, anxiety, stress and well-being.For participants consuming the MDsleep + hemp formula, the researchers found a significant negative association with sleep disturbance, indicating that people consuming this product “experienced a greater reduction in sleep disturbance over time compared to the placebo group.”

In addition, the researchers found that as the study progressed, participants using MDsleep + hemp products were “more likely to experience a decrease in anxiety compared to participants using placebo.” 

When looking at the effect on stress levels and overall well-being, the researchers also found that participants taking the MDsleep + hemp formula experienced more significant improvements over time than the placebo group. They found no differences in scores on pain levels. 

Future product developments 
Upcoming plans for MDsleep include additional clinical trials to demonstrate its long-term safety and efficacy further, notes Dougherty. “Continued research will solidify MDsleep’s position as an evidence-based sleep aid.”

In addition, he explains that MDsleep could be formulated as a sustained-release version for all-night sleep support. “A fast-acting formulation could also help those who have trouble falling asleep initially.” 

“For individuals with pain-related sleep disturbances, MDsleep could be combined with other botanicals or cannabinoids specifically targeting pain relief. This flexibility shows the potential for MDsleep in specialized applications.”

Additionally, MDBio aims to launch two new products — MDcalm for anxiety and MDrelief for pain management — currently in clinical trials. 

“Like MDsleep, these will undergo a rigorous clinical evaluation,” underscores Dougherty. “MDBio aims to bring pharmaceutical-level validation to supplements, allowing for tailored protocols with predictable effectiveness.”

By Jolanda van Hal