BackgroundAs the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that a modified Mediterranean-style, low glycemic load diet with soy protein and phytosterols had a more favorable impact than the American Heart Association Step 1 diet on cardiovascular disease (CVD) risk factors. Subsequently, we screened for phytochemicals with a history of safe use that were capable of increasing insulin sensitivity through modulation of protein kinases, and identified hops rho iso-alpha acid and acacia proanthocyanidins. The objective of this study was to investigate whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia.MethodsForty-nine subjects with metabolic syndrome and hypercholesterolemia, aged 25–80, entered a randomized, 2-arm, 12-week intervention trial; 23 randomized to the MED arm; 26 to the PED arm. Forty-four subjects completed at least 8 weeks [MED (n = 19); PED (n = 25)]. All subjects were instructed to follow the same aerobic exercise program. Three-day diet diaries and 7-day exercise diaries were assessed at each visit. Fasting blood samples were collected at baseline, 8 and 12 weeks for analysis.ResultsBoth arms experienced equal weight loss (MED: -5.7 kg; PED: -5.9 kg). However, at 12 weeks, the PED arm experienced greater reductions (P < 0.05) in cholesterol, non-HDL cholesterol, triglycerides (TG), cholesterol/HDL and TG/HDL compared with the MED arm. Only the PED arm experienced increased HDL (P < 0.05) and decreased TG/HDL (P < 0.01), and continued reduction in apo B/apo A-I from 8 to 12 weeks. Furthermore, 43% of PED subjects vs. only 22% of MED subjects had net resolution of metabolic syndrome. The Framingham 10-year CVD risk score decreased by 5.6% in the PED arm (P < 0.01) and 2.9% in the MED arm (P < 0.05).ConclusionThese results demonstrate that specific phytochemical supplementation increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD.

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A 13-week, randomized, pilot trial of a 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 over a low glycemic load diet alone in subjects with cardiovascular risk factors

Abstract: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%.Key words: cardiometabolic disease, bergamot, antioxidant, myeloperoxidase, oxidized LDL, dyslipidemia, HbA1c. Résumé :Les auteurs ont examiné la sécurité et l'efficacité cliniques du F105 chez 11 sujets présentant une dyslipidémie modérée. Le F105 est une combinaison d'extrait de bergamote (Citrus bergamia, EB) et 9 extraits végétaux sélectionnés pour leur capacité à améliorer l'activité antioxydante et anti-inflammatoire de l'EB. In vitro, le F105 montrait une inhibition synergique de la capacité d'absorption des radicaux d'oxygène, de formation de peroxynitrite et de l'activité myéloperoxydase. Après 12 semaines d'administration quotidienne de F105, aucun effet secondaire indésirable relié au traitement ou changements de poids corporels n'étaient observés. Des changements statistiquement significatifs ont été notés quant au cholestérol total (−7,3 %), LDL-cholestérol (−10 %), non-HDL-cholestérol (−7,1 %), cholestérol/HDL (−26 %) et apolipoprotéine B (−2,8 %). Une analyse post hoc de 8 sujets présentant une HbA1c > 5.4 et un indice HOMA-IR >2 ou des triglycérides élevés a révélé des changements additionnels statistiquement significatifs en plus de ceux précédemment observés chez tous les sujets incluant les triglycérides (−27 %), oxLDL (−19 %), LDL/HDL (−25 %) triglycérides/HDL (−27 %), oxLDL/HDL (−25 %), et PAI-1 (−37 %). Une étude de cas de suivi d'une patiente de 70 ans, ne répondant pas à la thérapie par les statines et traitée au F105 quotidiennement, a démontré amélioration des variables cardiométaboliques pendant les 12 semaines similaire au sous-groupe. En résumé, le F105 est bie...