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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Body composition and cardiometabolic risk reduction following therapy with a multi-ingredient nutraceutical
Anna Maria Sironi1, Michela Franchini2, Vittoria Tessieri1
1Studio Medico di Dietologia e Diabetologia "AMS", Marlia (Lucca), Italy.
Background:
Women in perimenopause or postmenopause experience an increased susceptibility to cardiometabolic disorders due to hormonal and physiological changes. This study assessed the effects of a multi-ingredient nutraceutical formulation (Syndrema®, Ghimas S.p.A.) on metabolic, inflammatory and anthropometric parameters in at-risk women in perimenopause. The formulation was designed to simultaneously target several components: body fat mass, insulin resistance, dyslipidaemia, glycaemic homeostasis, arterial hypertension and oxidative stress.
Methods:
Twenty-four women in perimenopause or postmenopause (aged 45-60 years, BMI ≥27) participated in a 90-day prospective, single-arm observational study conducted in a real-life clinical setting. They received the nutraceutical alongside an isocaloric diet and a standardized physical activity regimen. Assessments of clinical, biochemical and body composition parameters were conducted at baseline and at the 90-day follow-up. Evaluations included anthropometrics, bioelectrical impedance analysis, lipid profile, inflammatory and metabolic markers, insulin and glucose levels and haemodynamic variables. Paired t-tests were used to evaluate changes over time.
Results:
After 90 days, participants showed significant reductions in body weight, body mass index, waist circumference, systolic blood pressure, low density lipoprotein cholesterol, triglycerides, C-reactive protein, homocysteine and uric acid. Bioelectrical impedance analysis indicated improved body composition with reductions in fat mass and fat mass percentage. Liver enzymes and azotaemia also declined, suggesting systemic benefits.
Conclusions:
The combination of a multi-ingredient nutraceutical and lifestyle modifications was associated with favourable changes in cardiometabolic, inflammatory and body composition parameters in women in perimenopause and postmenopause. These results support the role of early, non-pharmacological interventions in mitigating cardiometabolic risk during menopause. Further randomized controlled trials are needed to confirm efficacy and long-term outcomes.
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