The concept (named 'AB-Fortis') was developed by IFF Health to protect mineral integrity and minimise the release of free iron, increasing iron bioavailability and reducing gastrointestinal discomfort.
“The encapsulated iron is prevented from releasing in the stomach, and instead only releases when it enters the small intestine where the pH changes and the iron can be preferentially absorbed,” says IFF Global Health Category Manager, Ryan Lauchli.
“Preventing interaction with food and supplement matrices means that reactions of iron and components (like oxidation) are prevented.”
Figures from the World Health Organisation (WHO) suggest iron deficiency is responsible for approximately 50% of global anaemia cases, with pregnant and menstruating women particularly vulnerable.
Iron needs to be constantly replenished to avoid deficiency and food is the only natural source. However, bioavailability can vary and absorption is low with plant-based diets.
The alternative to dietary iron is oral supplementation, which can cause gastrointestinal (GI) problems, leading to low adherence, according to researchers involved in a study on AB-Fortis tolerability.
FS is the most popular form, but results from studies suggest a large number of adverse events (AEs) are associated with the immediate release of FS, ferrous fumarate, or ferrous gluconate formulations, they say.
Microencapsulation is posited as an effective alternative to prevent unpleasant organoleptic characteristics and GI side effects, as well as suppress intraluminal absorption inhibitors and improve bioavailability.
Researchers carried out a 14-day trial to assess the tolerability of a daily dose of 60mg of a microencapsulated ferric saccharate (MFS) AB-Fortis, compared to the same dose of FS.
Fifty-one pre-menopausal women, aged 18 to 50 years, was randomly assigned to the MFS or FS group (although two from each group later dropped out or were excluded from analyses due to poor compliance) and administered one capsule two hours before lunch.
Iron profile including haemoglobin levels, ferritin, transferrin saturation, and serum iron were determined at baseline. Ten participants were smokers and 19 showed a serum ferritin level greater than 30ug/L.
Daily questionnaires were collected to evaluate daily symptom variables, including frequency, intensity, duration, health status, sleep quality and stool consistency, while tolerability was determined by evaluating symptom incidence and frequency.
A higher proportion of FS subjects experienced at least one symptom, compared to the MFS group (91.5% versus 72.3%), while the percentage during washout was 74.5%.
Reports of GI complaints and/or symptoms were significantly higher among FS subjects, compared to both the MFS group and washout period - and there was no significant difference in adverse events between these two.
“Significantly lower intensity scores were observed for nausea, abdominal pain, and flatulence/abdominal swelling for MFS compared with FS. The overall daily intensity of nausea and flatulence/abdominal swelling was significantly higher during the supplementation with FS as compared with the washout period,” the authors write.
Conversely, higher overall daily intensity of heartburn was noted for MFS, although not considered clinically meaningful since high intensity was also observed with FS and during washout.
Furthermore, visual analogue scale (VAS) scores revealed higher acute intensity of flatulence or abdominal swelling for both MFS and FS, compared to washout, although duration was shorter with MFS. Duration for these symptoms plus nausea, diarrhoea, and metallic taste was significantly higher with FS supplementation.
There were no improvements in sleep parameters following supplementation, while the iron profile in each group remained normal – with the exception of a small increase in ferritin values in FS participants. Administration of either supplement was determined safe, with only mild intensity AEs reported.
Moreover, consumption of MFS did not appear to have any impact on health status, daily activity, bowel movement, and stool consistency, compared to FS.
“The comparative analysis showed that the tolerability profile of MFS consumption was comparable to a real-life setting (i.e., without iron supplementation) as opposed to that of FS,” the authors’ comment.
They therefore conclude that “findings are clinically relevant and have direct applicability for the use of MFS as a nutritional supplement to restore iron levels”.
Source: Molecular Sciences
Published online, October 14, 2022: http://doi.org/10.3390/ijms232012282
‘Tolerability of Oral Supplementation with Microencapsulated Ferric Saccharate Compared to Ferrous Sulphate in Healthy Premenopausal Woman: A Crossover, Randomized, Double-Blind Clinical Trial’
Authors : Marina Friling, Ana María García-Muñoz, Tania Perrinjaquet-Moccetti, Desirée Victoria-Montesinos, Silvia Pérez-Piñero, María Salud Abellán-Ruiz, Antonio J. Luque-Rubia, Ana Isabel García-Guillén, Fernando Cánovas and Eran Ivanir