The clinical study of the dietary supplement, derived from "Kalamata" organic olives by organic farms from Sparta, which have been selected among 150 different types of olives due to their high content of phenols, is now in the final stage.
"Starting April" as mentioned, speaking to AMNA, by the Associate Professor of Pharmacy of the NKUA Dr. Prokopios Magiatis who is the coordinator of the team that is carrying out the third successive study, and also by the multi-awarded olive producer George Sakellaropoulos, who offers part of his production for laboratory and clinical research, " the last stage of the 3rd clinical study begins, which is expected to be completed probably in the summer and will then lead to the release of the dietary supplement in capsule form".
The first part of the 3rd study was carried out from 2021 to 2022 in patients with hyperlipidemia, who received daily 2 capsules of the dietary supplement - already registerd to the Greek authorities (E.O.F.) - produced from the olives by Sakellaropoulos Organic Farms. The beneficial properties of Kalamata table olives for health, mainly in the lipid profile of volunteers and in particular in the LDL/HDL cholesterol ratio as well as in the protection of the cardiovascular system, resulted from clinical studies and research carried out from 2014 until today.
The exclusive selection of organic table olives from these specific organic farms was made due to their high content of phenols, specifically hydroxytyrosol and tyrosol, two substances that have been attributed antioxidant and cardioprotective properties.
These olives, as Mr. Sakellaropoulos points out, are organic, without pasteurization.
They are produced by the process of natural fermentation without chemical additives or preservatives and have superior organoleptic and quality characteristics that are also confirmed by the successive awards they have received all over the world.
"Analyses with the Nuclear Magnetic Resonance method showed that they exceed by a large percentage the average values of the other olives analyzed during the period 2014-2023 as they contain 1850 mg/Kg of phenols and the daily consumption of just 2-3 grams of olives provides more than 5 mg of hydroxytyrosol, tyrosol or their derivatives.
"In total, our organic farms offered more than 700 kg for the three clinical studies and for the preparation of the dietary supplement," said Mr. Sakellaropoulos.
Ten years of studies on organic Kalamata olives
The first study with table olives, which demonstrated internationally the beneficial effect of specific olives on the lipid profile of the participants, was carried out in healthy volunteers and lasted from 2014 to 2016. The results were presented at the conference of the Oleocanthal International Society at the International Olympic Academy.
This was followed by a second study in a larger group of patients from 2017 to 2022 entitled “ The effect of daily consumption of Kalamata table olives on the lipidemic profile of patients with hyperlipidemia”.
The research was carried out at the Hypertension Unit, First University Cardiology Clinic, Ippokratio GNA and at the Biopathological Laboratory of the 401 General Military Hospital of Athens, in collaboration with the Department of Pharmacy of NKUA. 94 volunteers participated, of which 71 completed the study.
Significant results were found in cholesterol and LDL levels of 71 patients (p<0.05), while no significant change in HDL and TG levels was observed. Cholesterol showed a significant decrease of 9.01 units and LDL levels showed a decrease of 10.98 units after only 30 days of daily consumption of just five olives.
Remarkable, according to the Associate Professor of the Department of Pharmacy of NKUA, Dr. Magiatis Prokopios, is that the type of olives used were the “ Valsamikes Kalamata Olives” by Sakellaropoulos Organic Farms which contained hydroxytyrosol 1300 mg/Kg and tyrosol 560 mg/Kg.
Daily consumption of 5 olives yielded 25 mg of hydroxytyrosol and 10 mg of tyrosol in each patient, and the results were published in the World Olive Center for Health's May 2022 annual edition.
The impressive results of these two clinical studies, with a daily intake of just 5 organic olives from Sakellaropoulos Organic Farms, allowed the research team of the Department of Pharmacy of NKUA to transform the olives in the form of powder into a capsule, with an international patent (of a German private company), and to conduct the 3rd study which was carried out in patients with hyperlipidemia, who received daily 2 capsules of the dietary supplement that has been registered to the National Organization for Medicines (Not. No. EOF: 94522/8-9-2022).
The first results of the 3rd clinical study led to its extension to a larger group of participating patients (>100 subjects, with borderline hyperlipidemia not receiving treatment) and the last part of the study starting in April 2023. In this last part of the study, the Kalamata olives by Sakellaropoulos Organic Farms with the commercial title “ Plus Health Kalamata olives”, will be used as raw material for the production of the dietary supplement.
"Let's be clear; this is not a drug," Associate Professor of the Department of Pharmacognosy and Natural Product Chemistry, Dr. Prokopios Magiatis said.
"It should be noted that neither olives nor the dietary supplement replace drugs for the control of hyperlipidemia, but the purpose of the study is to demonstrate that they could be used by people with borderline hyperlipidemia, combined with an appropriate dietary intervention.
"The reduction of hyperlipidemia, he added, by 10 units is important for a person who shows hyperlipidemia close to or slightly above the limit...
"Just as important is the laboratory finding that just five of the specific organic olives correspond to the preparation of one capsule of hydroxytyrosol- tyrosol of the supplement."
Other organic "Kalamata" olives with lower phenolic content increase the number of olives required to produce one capsule."
However, the professor pointed out that "the performance of the Kalamata olives regarding phenols and specifically hydroxytyrosol and tyrosol pertains to their natural way of fermentation and not the olives that have undergone chemical or thermal treatment".
New Yale research on the Greek olive
"The findings we have and the ease of use of these (Kalamata) olives with a content of phenols, constitute an important advance for cholesterol control," associate professor of NKUA noted.” The way is now paved for the next steps...
Two of the leading universities in the USA (Harvard and Yale) have respectively been carrying out similar studies in recent years on the nutritional value of organic olive oils and organic "Kalamata" olives by Sakellaropoulos Organic Farms.
In fact, at Yale, researchers from the Department of Cardiology have been conducting (new) research on 226 volunteers since last year under the title "Olives for Health" examining the benefits that their daily consumption entails for human health.
READ MORE: Greece ranks first place in the world for gourmet olive oil.