A 13-week low glycemic load diet and lifestyle modification program combining low glycemic load protein shakes and targeted nutraceuticals improved weight loss and cardio-metabolic risk factors.

An open-label, randomized, exploratory study of 44 healthy overweight subjects with cardio-metabolic syndrome (CMS) risk factors was conducted to assess the safety, tolerability, and efficacy of a proprietary lifestyle modification program without (DIET) and with (PROG) targeted nutraceutical supplementation, including phytosterols, antioxidants, probiotics, fish oil, berberine, and soy, pea, and whey proteins over 13 weeks. Key metrics were recorded at baseline and weeks 9 and 13. For the DIET and PROG groups, compliance was 85% and 86%, respectively, with no adverse events related to the diet or supplements. Twelve subjects discontinued participation before week 9 for reasons unrelated to the study. PROG subjects experienced greater decreases (p < 0.05) than DIET in body mass, fat mass, total cholesterol, LDL cholesterol, TG, cholesterol / HDL ratio, TG/HDL ratio, apolipoprotein B / apolipoprotein A1 ratio, and hs-CRP. The Framingham 10-year cardiovascular disease risk score decreased by 40% (p < 0.01) in the PROG arm versus no change for the DIET arm. As a pilot study, it was not possible to state whether the observed effects were the result of nutraceutical supplementation alone or the result of additive or synergistic interactions among diet, lifestyle modifications, and nutraceutical supplementation. Moreover, individuals with CMS risk factors following a lifestyle modification program received additional health benefits from targeted nutraceutical supplementation.

Synergistic in vitro antioxidant activity and observational clinical trial of F105, a phytochemical formulation including Citrus bergamia, in subjects with moderate cardiometabolic risk factors.

We examined the clinical safety and efficacy of F105 in 11 subjects with moderate dyslipidemia. F105 is a combination of bergamot fruit extract (Citrus bergamia, BFE) and 9 phytoextracts selected for their ability to improve the antioxidant and anti-inflammatory activity of BFE. In vitro F105 exhibited a synergistic inhibition of oxygen radical absorbing capacity, peroxynitrite formation, and myeloperoxidase activity. Following 12 weeks of F105 daily, no treatment-related adverse events or changes in body mass were seen. Statistically significant changes were noted in total cholesterol (-7.3%), LDL-cholesterol (-10%), non-HDL cholesterol (-7.1%), cholesterol/HDL (-26%), and apolipoprotein B (-2.8%). A post hoc analysis of 8 subjects with HbA1c > 5.4 and HOMA-IR score > 2 or elevated triglycerides revealed additional statistically significant changes in addition to those previously observed in all subjects including triglycerides (-27%), oxLDL (-19%), LDL/HDL (-25%), triglycerides/HDL (-27%), oxLDL/HDL (-25%), and PAI-1 (-37%). A follow-up case report of a 70-year-old female patient, nonresponsive to statin therapy and placed on F105 daily, demonstrated improved cardiometabolic variables over 12 weeks similar to the subgroup. In summary, F105 was clinically well-tolerated and effective for ameliorating dyslipidemia in subjects with moderate cardiometabolic risk factors, particularly in the individuals with HbA1c > 5.4%.