Vedic Lifesciences is a contract research organization based in Mumbai, India. We recently examined clinical trials conducted in the hemp and cannabinoid space. We analyzed a total of 27 studies whose investigational product included cannabinoid or other hemp products. This report is intended to cover nutraceutical-centric studies that incorporate cannabidiol (CBD) and its derivatives like hemp and CBD oil (different extracts and forms) as the investigational product.
This report describes our findings regarding:
Our findings will interest a broad range of industry professionals:
By attempting to identify the innovative health claims being investigated for specific forms of CBD, this report aims to help R&D teams formulate their functional ingredients or branded supplements using various CBD types and doses, and design unique trials with trending objectives. It also aims to help company managers make informed decisions about marketing their products and planning their growth and to provide companies looking to enter the CBD market with more information on results of recent clinical and preclinical studies.
In terms of our search methods, we used the clinical trial registry http://www.clinicaltrials.gov instead of a search engine like PubMed, which would only have yielded trends from published studies initiated more than two years ago. By contrast, a clinical trial registry provides more current data, including data on studies not yet completed.
Here are the filters we used in our analysis:
Health Area
Which health concerns is CBD being studied for?As Figure 1 shows, the majority of CBD research is on cognitive support. The primary objective of more than one-third of the studies we analyzed was some aspect of cognitive health. Secondary outcomes included changes in sleep, quality of life, physical activity, and behavioral patterns at baseline and end of the study. Figure 1 also shows that CBD is now being studied for metabolic health (weight management, glucose levels, lipid profiling).
Study Endpoints
Which study endpoints are these CBD studies focusing on? Table 1 provides a detailed look at some of the most common endpoints for health concerns ranging from cognition and metabolism to immunity, heart health, joint health, sleep, sports performance, and more.
Tools and Biomarkers
Which tools and biomarkers did these CBD studies use? Table 2 provides a detailed look at some of the most common tools and biomarkers used in studies for health concerns ranging from cognition and metabolism to immunity, heart health, joint health, sleep, sports performance, and more.
Sample Size
Interest in CBD has led to more than 150 proof-of-concept studies. Approximately 58% of the studies we analyzed had a sample size of fewer than 50 subjects. (See Figure 2) More companies and research institutes are initiating proof-of-concept/pilot studies on CBD. This would be a space to watch out for. Large-sample-size studies should follow suit based on the data obtained in the studies.
Completion Status
Interestingly, while more than 42% of the studies we analyzed had been completed, no results were highlighted in the clinical trials registry. (See Figure 3) Another fact we noticed is that close to 31% of the studies are currently recruiting. This means that the research on CBD has gained momentum in the last five years. Finally, both types of studiescompleted and in progressencompass a range of health areas, meaning several health claims are substantiated.
Study Duration
More than 53% of the total studies we analyzed had a duration of less than 12 monthswith some still in the recruitment phase in terms of their completion date. (See Figure 4) This fact, combined with a trend observed of smaller study sample sizes, indicates that several companies are interested in faster substantiation of their health claims. This may then lead to large-sample-size studies in the next couple of years and faster market inclusion of their products.
Safety vs. Efficacy Studies
While there are more of proof-of-concept studies, close to 77% of studies are efficacy studies rather than safety studies. This indicates that companies may be directly jumping into substantiating health claims rather than performing the quintessential safety assessment of different extracts of CBD.
Other Interesting Insights
When we analyzed the studiesexcluding those whose status was either withdrawn or unknown, two studies caught our attention, for different reasons.
First, in the study NCT05108220, 1350 female subjects aged 24-44 (working population) were recruited in order to investigate the effect of CBD on subjects anxiety levels. The dose-ranging study included CBD oil and capsules with 0.0%-0.3% THC content. In-Home Usage Tests (IHUT) were done to understand the different CBD compounds effects on anxiety in women.
Second study NCT04777981 was interesting. The focus was the effects of CBD, in combination with red algae, on symptomatic improvement in COVID-19 patients.
Other key takeaways is that interest in CBDs benefits is not just limited to cognition. While cognitive support is a known area of CBD research, interest in other health areas like heart health (hypertension), cancer (symptomatic improvement), sleep quality, immune health, and metabolic health demonstrate broad interest in CBD inclusion in the nutraceutical industry.
Recommendations for Research from a Regulatory Perspective
According to certification and testing firm FoodChain ID, both preclinical and clinical studies are mandated for regulatory submission for any novel food. These include the bacterial reverse mutation test, in vitro micronucleus test in mammalian cells, and a 90-day study. Also for CBD, global standardized guideline tests to be done would be OECD 451,452, 443, and 422.
After preclinical studies are concluded, a safety study in healthy individuals is needed. Safety can be analyzed by assessing the comprehensive metabolic panel, which tests the levels of electrolytes and kidney and liver parameters. Tests can also include lipid profile, hormone profiling for men and women, semen analysis, and inflammatory biomarkers.
Another good practice is understanding the sleep quality, cognitive health, and gut parameters using questionnaires. This data can then be studied in conjunction with the safety tests to draw final conclusions about the effect of CBD in humans.
About the Author
Palak Vaval is Senior Associate Business Development, at Vedic Lifesciences, a contract research organization (CRO) based in India. She caters to North & South American nutraceutical companies claims substantiation requirements. With a Masters degree in Life Sciences (Biotechnology), Vaval has close to a decades worth of experience in sales and digital marketing with respect to the food and nutraceutical industry.
Read more from the original source:
Analyzing CBD studies: Health concerns, health claims, populations ... - Nutritional Outlook
- Transmute Coin Introduces Process for Recycling Carbon-based Materials with Zero CO2 Emission & Waste Pollution - PRNewswire [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- Fall River mom of two who shouldnt be alive turned life around after alcoholism - SouthCoastToday.com [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- Plant-based and functional flavors to dominate in 2020, experts say - Food Dive [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- New Insurance Cover Option For Some U.S. Hemp Farmers - HempGazette [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- The FDA & CBD: FDA Warning Letters Hint At Future CBD Regulation - Ministry of Hemp [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- Why Boxers Are in Love with CBD Gummies - WBN - World Boxing News [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- EaDos CBD-Infused Coffee Shop Is Set to Open Spring 2020 - Eater Houston [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- CBD and Lupus All You Need to Know in 2020 - LoudCloudHealth [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- What is CBD oil, and why is it so expensive? - Business Insider [Last Updated On: December 26th, 2019] [Originally Added On: December 26th, 2019]
- Does CBD oil cause withdrawals? - The GrowthOp [Last Updated On: January 10th, 2020] [Originally Added On: January 10th, 2020]
- 1933 Industries Provides an Update on its Nevada Hemp Processing Facility - Yahoo Finance [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- Trump Scraps Obama's Controls That Stopped Pollution From Being Dumped in Streams - The Daily Beast [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- CBDOilUsers.com Names Lazarus Naturals CBD Brand of the Year - CBD Today [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- How to Make CBD Tea? - The Leaf Online [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- HempAmericana Set for Initial Delivery in 90,000-Pound Hemp Flower Tolling Agreement with Hempistry - Yahoo Finance [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- Texas CBD products are everywhere. Here's what you should know. - The Texas Tribune [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- On CBD Oil - Why Hemp CBD is Being Used by Athletes Everywhere - The Sports Daily [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- 10 Reasons You Should Add CBD Oil to Your Morning Regimen - BBN Times [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- Vermont CBD Company, Sunsoil, Challenges Industry by Offering CBD Oil at the Lowest Cost Nationwide for the whole month of February - EnerCom Inc. [Last Updated On: January 24th, 2020] [Originally Added On: January 24th, 2020]
- USA CBD Expo Scheduled To Hold In Las Vegas This February - Bitneni [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- Hempcine.com: Your Go-To-Store For The Best CBD Products Online - Bitneni [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- Having trouble sleeping? cbdMD has you covered - Yahoo Finance [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- The CBD Skincare Market Could be Worth $959 Million by 2024, According to New Report - PRNewswire [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- Plus CBD Oil Becomes First-Ever CBD Sponsor of the Farmers Insurance Open Golf Tournament - TimesOfCBD [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- St Neots mum continues fight to give daugher CBD Oil in school | Huntingdon and St Neots News | The Hunts Post - Hunts Post [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- Soaps, Tinctures, Topicals: Oh My! Choosing The CBD Delivery Method That Works Best For You - Forbes [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- CBD, hemp and similar legal products are confusing the police and putting users at risk - NBC News [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- CBD vs. THC: The Differences - Observer [Last Updated On: January 26th, 2020] [Originally Added On: January 26th, 2020]
- CBD Is Booming Right Now But What Sets Superflower Apart From The Competition - Forbes [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Can crypto disrupt the CBD oil industry? - TechBullion [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Pressure BioSciences Accelerating Rollout of Proprietary UST Platform for Water-Soluble CBD with Planned Release of Additional BaroShear Instrument -... [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Although the effects of CBD have not been validated in humans, anecdotal evidence abounds - Tampa Bay Newspapers [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Drinks with CBD: Are they safe and are they legal? - CNET [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- 10 Best CBD Gummies And Why Athletes Are Using Them - Forbes [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Hemp CBD Demand Is Poor. Prices Are Falling, in a Blow to Farmers - Barron's [Last Updated On: February 1st, 2020] [Originally Added On: February 1st, 2020]
- Love Island's Olivia Buckland says she turns to CBD oil to tackle anxiety as it 'takes the edge off' - OK! magazine [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- A new chapter in the world of medicine. CBD for pain relief and opioid addiction treatment. - The Urban Twist [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- New CBD brand aims to blow away the blues - ResponseSource [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Man jailed for having cannabis at home; defence said he had become confused about CBD oil and what cannabis was legal and what was not - Echo Live [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- A CBD treatment at Rudding Park Hotel & Spa | Telegraph Travel - The Telegraph [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- CBD-Rich Tincture for Inflammation and Pain - Project CBD [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- The 5 Best Types Of CBD Beauty Products - The Fresh Toast [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Past and future: the growth of CBD medicine - Health Europa [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Giving students access to CBD products - KIMT 3 [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Nursing homes can't administer medical cannabis. This bill would change that. - wtvr.com [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Here are the main benefits of CBD oil - AZ Big Media [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Get 50% off Some of the Best Organic CBD Oil out There - Gear Patrol [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- What's in that CBD? Maybe not what you think. - USA TODAY [Last Updated On: February 27th, 2020] [Originally Added On: February 27th, 2020]
- Here's the Likely Reason Why Charlotte's Web Stock Is Crushing It Today - The Motley Fool [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- 5 healthy things to stock up on during self-isolation - IOL [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- Swiss Original Cannabis is expanding into the UK - Journalism.co.uk [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- A first-of-its-kind permit to export cannabis oil from the US to Israel was granted to Panaxia and its partner Ultra Health - Yahoo Finance [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- COVID-19 and cannabis: can CBD be used to help ward off or treat the coronavirus? - Straight.com [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- The Best CBD Isolate Products On the Market - L.A. Weekly [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- Buy CBD Oil - Best and Pure for Sale - Vape, Hemp, Cream ... [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- CBD Oil - The #1 CBD Oil for Sale [Last Updated On: March 26th, 2020] [Originally Added On: March 26th, 2020]
- Hubei Told Not to Cover Up Virus Cases This Time as Its Lockdown Is Lifted After Two Months - The Daily Beast [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Cannabis and coronavirus: Here's what you need to know - Leafly [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- 5 questions with Danica Patrick about why she invested in a CBD company - For The Win [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- The Green Organic Dutchman Receives Health Canada Licence Amendment for its Ancaster Processing Facility - Yahoo Finance [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Canadian Scientist Wants To Research Cannabis As Treatment For COVID-19 - The Fresh Toast [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- CBD Oil Market 2025 Expected to Rise at A Higher CAGR Value, Driving Factors, Sales and Revenue - Daily Science [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- CBD & Coronavirus: CBD Can't Cure Or Prevent COVID-19 - Ministry of Hemp [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Curaleaf buoyed by increase in hemp oil demand during crisis - NutraIngredients-usa.com [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Hemp farming approved to begin in Georgia this summer - Atlanta Journal Constitution [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Tanner Quinn shares his story of selling CBD products and the business hurdles he faces - Ke Alakai [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Empire Hemp Co. offers all-natural hemp CBD oil and topical products at walk-up window weekdays - The Batavian [Last Updated On: March 31st, 2020] [Originally Added On: March 31st, 2020]
- Five Alternative Ways to Get Rid of Anxiety - Big Easy Magazine [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Impact of COVID-19 Outbreak on CBD Oil Market Global Sales, Trends, Regional Demand, Opportunities and 2020-2026 Future Insights - Cole of Duty [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- The Ultimate Mother's Day Giveaway Is Here - hobokengirl.com [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- 5 Great Cannabis Skin Care Products To Consider Trying - Anti Aging News [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- First hemp CBD production facility and retail store in Idaho opens in Idaho Falls - LocalNews8.com [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Medical Marijuana, Inc. Names Caroline Heinz and Raul Elizalde Co-CEOs of Subsidiary HempMeds, Appoints Todd Morrow to Chief Information Officer -... [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Surely Youve Tried CBD By Now? - British Vogue [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Top 3 CBD Recipes to Try Over the Weekend - Plants Before Pills [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Dispelling the Myth That Cannabis Can Cure COVID-19 - Good Times Weekly [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Real Tested CBD Brand Spotlight: Endoca - SF Weekly [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Analysis on New Product Launches in Covid-19 Related Markets-CBD Oil Market 2020-2024 | Health Benefits of CBD Oil To Boost Growth | Technavio -... [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- What Is CBD Bioavailability, and Why Is It Important? - CSPDailyNews.com [Last Updated On: May 8th, 2020] [Originally Added On: May 8th, 2020]
- Boosting the booze: Ingredient innovations and 'healthier options' key to survival for APAC alcohol sector - FoodNavigator-Asia.com [Last Updated On: May 15th, 2020] [Originally Added On: May 15th, 2020]