Role of an eco-sustainable supply chain in the world of dietary supplements: green tea extract in overweight and obese post-menopausal women

Background: The GTEPOWER (Green Tea Extract in Postmenopausal Obese Women: Environmentally sustainable Randomized trial) study aims to develop an environmentally sustainable green tea extract supplement and to evaluate its impact on the lipid profile and on the body composition in overweight and obese post-menopausal women (PMW). 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 observed in women after menopause. Material and Methods: Based on preliminar power analysis, a single-blind randomized controlled intervention trial will recruit 80 PMW (naturally or surgical, excluding those on hormone replacement therapy or those on prior chemo or radiation therapy) aged between 40 and 65 years, with BMI between 24 and 38 kg/m2 and following the exclusion criteria (active neoplastic disease, decompensated thyroid disease, autoimmune diseases undergoing specific pharmacological treatment, evident psychiatric disorders and advanced cardiovascular, hepatic and renal pathologies). Each randomly recruited PMW will sign an informed consent and will undergo a one-month Mediterranean diet (run-in phase) to homogenize the sample. Then they will be randomly assigned to one of two groups: intervention group (n= 40) with green tea extract capsule for 3 months and placebo group (n = 40). Each PMW will be followed-up for 6 months (including the run-in phase) with monthly outpatient reassessments for the first 4 months and the last visit 2 months after the last supplement intake. A detailed questionnaire on lifestyle, medical history and physical activity, IPAQ (Physical Activity Questionnaire), Food Frequency Questionnaire will be administered at each visit. The outpatient assessment will include anthropometric measurements, detection of vital parameters such as systolic and diastolic blood pressure, heart rate, body composition, subclinical atherosclerosis assessment with tonometry, performance test (Gait Speed and timed up and go), and hand grip strength test with dynamometer. At each visit, blood samples for biochemical measurements will be taken. A weekly food diary will be provided. Green tea extract capsule was obtained from thirty kilo of Mao Feng green tea leaves coming from a sustainable plantation in Yunnan, China. The tea leaves were dried by dry heat without any oxidation and extracted with 60% etanol (D:S 1:10 V/V) at 60°C for 60 min in an Italian specialized firm. The extract was processed through filter press, concentrated at 40°C under vacuum, pasteurized at 80°C and dried in spray dried pilot with 30% maltodextrin added. Placebo capsules contain inert substances and look similar to green tea capsules. The packaging is environmentally sustainable, packaged in biodegradable bottles derived from corn. Results: The all procedure is ongoing. So far, the obtained dry extract has a weight yield of 20-24%, EGCG concentration of 17.1% and Caffeine concentration of 19.5%. The General Directorate for Hygiene and Food Safety and Nutrition of the Ministry of Health has set the maximum daily intakes of caffeine (Prot. 6191-P-22/02/2017) and of EGCG (Reg. (UE) 2022/2340) with food supplements at 200 mg and 800 mg, respectively. In compliance with the legislation, a total of 175 mg of EGCG and 200 mg of Caffeine will be administered daily to each participant for 3 months. Conclusions: This project is designed to promote the safety of dietary supplements in the face of climate change and biodiversity loss to improve people's health, quality of life and care for nature.