Int J Med Sci 2022; 19(3):563-571. doi:10.7150/ijms.70435 This issue

Research Paper

Potential impact of functional biomolecules-enriched foods on human health: A randomized controlled clinical trial

Marco Tatullo1✉, Benedetta Marrelli2, Caterina Benincasa2, Elisabetta Aiello2, Massimiliano Amantea2, Stefano Gentile2, Noemi Leonardi2, Maria Luisa Balestrieri3,#, Giuseppe Campanile4,#

1. Department of Basic Medical Sciences, Neurosciences and Sense Organs, P.ce G. Cesare 11, University of Bari Aldo Moro, 70124 Bari, Italy;
2. Marrelli Health - Tecnologica Research Institute, Biomedical Section, Street E. Fermi, 88900 Crotone, Italy;
3. Department of Precision Medicine, University of Campania Luigi Vanvitelli, Via L. De Crecchio 7, 80138 Naples, Italy;
4. Department of Veterinary Medicine and Animal Production, University of Naples Federico II, 80137 Naples, Italy.
#These authors equally contributed to this article

This is an open access article distributed under the terms of the Creative Commons Attribution License ( See for full terms and conditions.
Tatullo M, Marrelli B, Benincasa C, Aiello E, Amantea M, Gentile S, Leonardi N, Balestrieri ML, Campanile G. Potential impact of functional biomolecules-enriched foods on human health: A randomized controlled clinical trial. Int J Med Sci 2022; 19(3):563-571. doi:10.7150/ijms.70435. Available from

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Graphic abstract

Naturally occurring milk compounds have recently been investigated for their health-promoting properties; in fact, their anti-microbial, immuno-modulatory, antioxidant and anti-thrombotic activities, have increasingly gained interest within the scientific community. We have reported a translational, randomized, controlled clinical trial (RCT) on human subjects with a moderate to high cardiovascular risk, and a body mass index (BMI) >25.1 kg/m2, to evaluate the clinical impact of biomolecules-enriched Mediterranean Buffalo (Bubalus bubalis) milk and its derived dairy foods, produced with innovative breeding techniques. The experimental arm involved patients that followed a diet including the above-described products (treated group; n= 11); the control arm was based on a diet including cow milk and its dairy products (control group; n= 9). The results of this study have been statistically evaluated, pointing out a specific significance related to the comparative analysis of the blood pressure among the 2 arms; in fact, this value showed a significant improvement in an extremely short experimental time. Nevertheless, this study also reported not-significant results that were indicative of an interesting and promising tendency in modulating specific diet-depending haematological and biomedical values. In conclusion, this RCT has assessed that the foods derived from buffalo milk naturally enriched with biomolecules, was able to improve the overall blood glucose levels, the BMI and the body weight. These preliminary results are suitable for the design of future strategies in the prevention of cardiometabolic diseases, thus improving the overall quality of life and the policies of healthcare management.

Keywords: buffalo milk, betaine, healthcare