The randomized, double-blind clinical trial used Sidevit B12, a newly launched product that expands PharmaNutra’s award-winning portfolio of sucrosomial technology, a patented delivery system that protects the molecules of micronutrients, increasing their absorption and bioavailability.
“Sucrosomial B12 was the only formulation to surpass the deficiency-borderline threshold (200–300 pg/mL) within 24 h of the first dose and was well tolerated with no reported side effects,” wrote researchers from Italy, Pakistan, and the University of Oxford in Frontiers in Nutrition.
“This advanced formulation is particularly beneficial for individuals at increased risk of deficiency, including the elderly, vegetarians, vegans, and those with GI conditions that hinder B12 absorption, such as pernicious anemia, celiac disease, Crohn’s disease, and irritable bowel syndrome (IBS), among others” they added.
Sucrosomial technology improves absorption
Oral B12 supplements are a common approach to maintaining adequate circulatory levels in individuals at risk of deficiency, such as vegans, older people, and those with digestive disorders.
However, in some of these populations, such as those with autoimmune conditions and the older generation, the production of intrinsic factor, which is crucial for absorption, can be reduced. This makes it more difficult to absorb conventional oral supplements, such as cyanocobalamin and methylcobalamin, which must also survive the harsh environment of stomach acid and enzymes.
Sucrosomial technology reportedly presents an effective solution to overcome absorption challenges, supported by previous research on other PharmaNutra products such as sucrosomial vitamin D3.
“This system entraps the active agent within a lipid-based vesicle, enhancing its stability during transit through the GI tract and improving its absorption by protecting the active agent from degradation, controlling its release, and promoting its passage across the intestinal barrier,” the researchers wrote.
However, they note that some sucrosomial B12 potentially enters the bloodstream intact and is released into the liver, and this possibility requires further investigation.
Study details
The double-blind trial randomized 76 healthy participants with suboptimal B12 levels across three centers to receive 1,000 micrograms (mcg) daily of oral sucrosomial B12 or a conventional B12 supplement that differed in brand in each center for seven days.
Serum B12 levels were measured at baseline and every other day throughout the study period. The researchers also assessed full blood count and vital signs.
The results showed that the sucrosomial B12 was significantly more effective at increasing and maintaining higher circulatory B12 levels across all time points than conventional supplements randomly selected from pharmacies.
Additionally, sucrosomial B12 was the only supplement that raised circulatory B12 levels above the deficiency-borderline threshold (200–300 pg/mL) within the first 24 hours.
The authors note the potential bias in the study as there was a higher ratio of male participants who may be more susceptible to B12 deficiency and women with hormonal changes that may contribute to deficiency. Therefore, they call for further studies with more sizeable, balanced populations and extended study periods.
Source: Frontiers in Nutrition
2024, Volume 11, https://doi.org/10.3389/fnut.2024.1493593
“Comparative bioavailability study of supplemental oral Sucrosomial® vs. oral conventional vitamin B12 in enhancing circulatory B12 levels in healthy deficient adults: a multicentre, double-blind randomized clinical trial”
Authors: N.M. Memon et al.