ROLE OF AN ECO-SUSTAINABLE SUPPLY CHAIN IN THE WORLD OF FOOD SUPPLEMENTS: GREEN TEA EXTRACT IN POST- MENOPAUSAL WOMEN WITH OVERWEIGHT AND OBESITY

Background: With the onset of menopause, loss of the protective effect of estrogen and changes in body fat distribution with increased abdominal obesity and dyslipidemia might be observed. Those metabolic and anthropometric modifications underlie the possible acceleration of cardiovascular disease (CVD) observed in women after menopause. Numerous experimental studies have highlighted the benefits of green tea extract supplements (Camellia sinensis L. Kuntze) containing epigallocatechin-3-gallate (EGCG), which inhibits gastric and pancreatic lipase and fatty acid synthesis, accelerates lipid metabolism and interferes with lipid emulsification, digestion and micellar solubilization, leading to a reduction in total and LDL cholesterol levels and waist circumference. However, there is currently a lack of specific studies in postmenopausal women. Aim of the study: The GTEPOWER study (Green Tea Extract in Postmenopausal Obese Women: Environmentally Sustainable Randomized Trial) aims to develop an environmentally sustainable green tea extract supplement and to evaluate, through a single-center, randomized, controlled, single-blind interventional trial, the impact on the reduction of adiposity indices and metabolic profile changes in postmenopausal women with overweight and obesity. Material and Methods: The green tea extract was obtained through extraction with 60% ethanol (D:S 1:10 V/V) at 60°C for 60 minutes from 30 kg of Mao Feng green tea leaves (Camellia Sinensis L. Kuntz), dried without oxidation and sourced from Yunnan, China. The extract was filtered, concentrated, pasteurized, dried using a spray dryer with the addition of 30% maltodextrin and encapsulated in transparent, acid-resistant, size 00 vegetable capsules. The placebo capsules, also size 00, are vegetable, green-colored, and contain inert substances. The packaging is eco-sustainable, biodegradable bottles derived from corn. The clinical trial GTEPOWER is designed to enroll 76 women in physiological menopause, 44<age<66 years, 25≤BMI<35 kg/m2, with LDL cholesterol ≤190 mg/dl in the absence of lipid-lowering therapy and with a 10-year risk of total atherosclerotic CVD (<2.5% for age <50 years and <5% for age 50-69 years according to SCORE 2). Patients will receive a balanced low-calorie dietary plan based on the Mediterranean diet to follow for the entire duration of the study. After an initial month of diet (run-in), patients will take 2 capsules or green tea extract supplement (n=38) or placebo (n=38) twice a day for 90 days. Results: Each capsule contains 420 mg of dry extract of Camellia sinensis L. Kuntze, with a total of 66.78 mg of catechins (15.9%), including 23.94 mg of EGCG (5.7%) and 21.84 mg of caffeine (5.2%). The supplement has been subjected to an electronic notification procedure to the Ministry and included in a specific Register of Supplements of the Ministry of Health with the specific code GREEN PAUSE 170960. So far, two patients have been enrolled at the outpatient clinic of the UOC of Dietetics and Clinical Nutrition, Azienda Ospedale-Università Padova. After 30 days of the run-in phase, the patients decreased their weight by 2% following a Mediterranean Diet. No side effects have been reported. Conclusion: The GTEPOWER study represents not only an innovation in the field of supplements but also a concrete example of how research can embrace the principles of sustainability at every stage, from production to distribution. The choice to use raw materials from responsible agricultural practices, the adoption of low-impact extraction and production methods, and the use of eco-sustainable packaging solutions demonstrate a commitment to reducing the ecological footprint and promoting a greener future. This approach not only addresses the health challenges faced by menopausal women but also contributes to creating a more equitable and environmentally respectful economic system, in line with global sustainability goals.