The study is reportedly the first to investigate the effects of this ingredient without a central study location, and offers a valuable example of how remote studies could be performed in the future.
BASF collaborated with InsideTracker, a web-based participant management platform, and Nutrasource, a contract research organization to manage the tracker application, to run the trial, which included 32 healthy adults randomly assigned to receive placebo or the novel phytosterol supplement (Vegapure 95E).
One month of phytosterol supplementation was found to significantly lowered LDL-cholesterol levels by 10.2%.
“The 10.2% reduction in LDLc achieved with the new Vegapure 95E phytosterol emulsion in this study is significant and clinically meaningful when compared to previous investigations testing the dietary supplement format,” wrote the researchers, led by Ashley Reaver from Segterra (Inside Tracker).
“Limited data is available on the LDLc-reducing effects of dietary supplements containing plant sterols and stanols… Considering the limited comparability among studies, it is still remarkable that the LDLc-lowering effect in the current study was about 25% larger than the average of previous studies extrapolated to a 1.5 g of plant sterols or stanols per day as dietary supplement intake, indicating improved efficacy of this formulation.”
BASF’s phytosterol innovation
Sterols and stanols are typically used in dietary supplements and as functional ingredients in food products to reduce cholesterol. Numerous clinical trials in controlled settings have reported that daily consumption of 1.5 to 3 grams of phyto-sterols/-stanols from foods can reduce total cholesterol levels by 8% to 17%, representing a significant reduction in the risk of cardiovascular disease.
The US FDA approved health claim states that 1.3 grams of plant sterols per day as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. (For plant stanols, the daily dose increases to 3.4 grams)
For the Vegapure product, BASF partnered with The Aenova Group to develop the micro-emulsifying plant sterol ester complex that competes with cholesterol for uptake in the gut. The patented Vegapure Emulsorb is delivered in easy-to-swallow, vegan capsules.
The new randomized, placebo controlled, double blind, crossover study recruited participants from InsideTracker’s web and social network followers. Participants were randomly assigned to receive the three Vegapure 95E capsules per day (emulsion composed of 80% phytosterol esters, enzymatically modified sunflower lecithin, ascorbyl palmitate, and sunflower oil to give a total daily dose was 1.5 g/day phytosterol equivalent) or placebo (sunflower oil) for one month. This was followed by a one month ‘washout’ period (no intervention), before the participants crossed over to the other group for another month.
“The novel study design enabled the recruitment of a more diverse study population than traditional methods, and it allowed for daily monitoring of participant progress and compliance via the participant management system,” explained Reaver and her co-workers.
“This study is, to the authors’ knowledge, the first study to investigate dietary effects of phytosterols to be conducted without a central study location. As such, it serves as an example for future research studies utilizing remote study management.”
The Vegapure 95 E supplements were associated with significant reductions in LDL-cholesterol levels of 10.2%, but not changes were observed between the groups for secondary biomarkers such as fasting glucose, high sensitivity C-reactive protein (a marker of inflammation), the liver enzymes ALT, AST and GGT, or for levels of vitamin D, folate, vitamin B12, calcium, or magnesium.
“The phytosterol formulation developed for this study delivers optimal conditions for effective cholesterol lowering in vivo and substantiates the efficacy of this formulation in a clinical trial,” wrote the researchers. “The reduction in LDLc seen in our clinical trial provides evidence for the efficacy of this formulation.”
Study design for the future?
Commenting on the design study and protocol, Rod Butt, SVP Strategic Solutions at Nutrasource, told us: “Running virtual trials is a key milestone for dietary supplements.
“This design allows one to assess the impact of a novel product in a real-world setting and is the foundation for testing the effectiveness of products when administered as they would be at home. The advancements in technology, including virtual consents and cloud-based data capture combined with the “Amazon” effect on home delivery has made the operationalization of virtual trials feasible.”
Dr. Gil Blander, Founder & Chief Scientific Officer of InsideTracker, added: “We are extremely proud of our paper and this first of its kind collaboration between BASF, InsideTracker and Nutrasource. Together we pioneered a siteless clinical study design that required no physical space, no paper documents and no time wasted. We feel its success will serve as a role model for future non-traditional approaches.
“To reduce the typical operational inefficiencies and heavy human capital requirements, InsideTracker developed an online management tool that comprehensively handled all aspects of recruitment, screening, onboarding, endangerment management and compliance. With the majority of the interaction occurring virtually, we can now significantly expedite, simplify and reduce costs for future research.”
2019, 11(9), 2108; doi: 10.3390/nu11092108
“A Randomized, Placebo-Controlled, Double-Blind Crossover Study to Assess a Unique Phytosterol Ester Formulation in Lowering LDL Cholesterol Utilizing a Novel Virtual Tracking Tool”
Authors: A. Reaver et al.