Artichoke Extract (Digestion)

BACKGROUND/OBJECTIVES: The increasing incidence of metabolic dysfunction-associated steatotic liver disease (MASLD) poses a major healthcare challenge. This condition is particularly prevalent in patients with obesity. Artichoke leaf extract (ALE) has known hepatoprotective, antioxidant, and lipid-lowering properties. While ALE has been studied for its impact on liver metabolism, its specific effectiveness in individuals with obesity and MASLD remains unclear. This study investigates the effectiveness of ALE in reducing liver steatosis in patients scheduled for bariatric surgery. To our knowledge, this is the first study to examine ALE's "antisteatotic" efficacy in this clinical context. METHODS: Forty participating bariatric surgery candidates received either ALE or a placebo for 6 weeks before measurements. Steatosis was quantified using FibroScan (controlled attenuation parameter, CAP), and liver size was assessed via ultrasound. Secondary outcomes included serum laboratory parameters and body composition, measured through bioelectrical impedance analysis. RESULTS: ALE intake significantly reduced CAP values and liver lobe diameters compared to placebo, indicating decreased steatosis and liver volume. Improvements were already evident after 3 weeks. In female participants, total and low-density lipoprotein cholesterol levels improved. However, transaminase levels-particularly aspartate aminotransferase-increased in the ALE group. Body composition improved, with reductions in fat mass percentage. CONCLUSIONS: ALE effectively reduces liver steatosis and size and improves body composition in patients with obesity and MASLD. Unlike prior studies, we observed a significant transaminase increase, suggesting a distinct hepatic response in individuals with obesity. Further research is needed to evaluate ALE's metabolic and hepatic effects specifically in this population beyond the prebariatric setting.

BACKGROUND: Currently, there is no approved medication for non-alcoholic fatty liver disease management. Pre-clinical and clinical studies showed that several bioactive molecules in plants or foods (i.e., curcumin complex, bergamot polyphenol fraction, artichoke leaf extract, black seed oil, concentrate fish oil, picroliv root, glutathione, S-adenosyl-L-methionine and other natural ingredients) have been associated with improved fatty liver disease. Starting from these evidences, our purpose was to evaluate the effects of a novel combination of abovementioned nutraceuticals as a treatment for adults with fatty liver disease. METHODS: A total of 140 participants with liver steatosis were enrolled in a randomized, double-blind, placebo controlled clinical trial. The intervention group received six softgel capsules daily of a nutraceutical (namely Livogen Plus®) containing a combination of natural bioactive components for 12 weeks. The control group received six softgel capsules daily of a placebo containing maltodextrin for 12 weeks. The primary outcome measure was the change in liver fat content (CAP score). CAP score, by transient elastography, serum glucose, lipids, transaminases, and cytokines were measured at baseline and after intervention. RESULTS: After adjustment for confounding variables (i.e., CAP score and triglyceride at baseline, and changes of serum γGT, and vegetable and animal proteins, cholesterol intake at the follow-up), we found a greater CAP score reduction in the nutraceutical group rather than placebo (- 34 ± 5 dB/m vs. - 20 ± 5 dB/m, respectively; p = 0.045). The CAP score reduction (%) was even greater in those with aged 60 or less, low baseline HDL-C, AST reduction as well as in men. CONCLUSION: Our results showed that a new combination of bioactive molecules as nutraceutical was safe and effective in reducing liver fat content over 12 weeks in individuals with hepatic steatosis. Trial registration ISRCTN, ISRCTN70887063. Registered 03 August 2021-retrospectively registered, https://doi.org/10.1186/ISRCTN70887063. © 2022. The Author(s).

Medicinal plants are widely used as a complementary therapy to treat complex diseases, such as nonalcoholic fatty liver disease (NAFLD). Therefore, this study was done to investigate the effect of co-administration of artichoke leaf extract supplement (ALES) with conventional medicines on patients with NAFLD. The clinical trial was based on patients randomly divided into three groups involving metformin-vitamin E (ME), metformin-ALES (MA), and vitamin E-ALES (EA). The effectiveness of treatment in the treated groups was evaluated using liver ultrasonography and biochemical markers. After 12 weeks of treatment, the results showed that the rate of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was significantly reduced within all the study groups (p < .05). Liver ultrasonographic findings revealed that the rate of fat accumulation in liver of patients was decreased significantly within all the study groups and it was increased in the subjects with grade 0 fatty liver (without fat accumulation) in the MA and EA groups by 23.3 and 17.2%, respectively. In summary, the results of the present study showed that the concomitant use of ALES with metformin and vitamin E can have beneficial effects on amelioration of complications in patients with NAFLD. However, larger-scale clinical trial studies are required in this regard. © 2021 John Wiley & Sons Ltd.

Due to the enormous variety of phytochemicals present in plants, their extracts have been used for centuries in the treatment of innumerable diseases, being perceived as an invaluable source of medicines for humans. Furthermore, the combination of different plants was reported as inducing an improved effect (synergism) in comparison with the additive activity of the plants present in those mixtures. Nevertheless, information regarding the effects of plant infusions added with honey is still rather scarce. Accordingly, the aim of this study was to evaluate the interaction between chestnut honey, a natural product with well-reported beneficial properties, and three medicinal plants (either as a single plant or as combinations of two and three plants), with regard to their antioxidant activity and hepatotoxicity. Antioxidant activity was evaluated by comparing the results from four different assays; hepatotoxicity was assessed in two different cell lines. Results were compared by analysis of variance and linear discriminant analysis. The addition of honey to the infusions had a beneficial result in both cases, producing a synergistic effect in all samples, except β-carotene bleaching inhibition for artichoke + milk thistle + honey preparation and also preparations with lower hepatotoxicity, except in the case of artichoke + honey. Moreover, from the discriminant linear analysis output, it became obvious that the effect of honey addition overcame that resulting from using single plant or mixed plant based infusions. Also, the enhanced antioxidant activity of infusions containing honey was confirmed by lower hepatotoxicity.

High-dose aqueous extracts from artichoke leaves were found to inhibit cholesterol biosynthesis from (14)C-acetate rather moderately in HepG2 cells in contrast to primary cultured rat hepatocytes in which the inhibition was stronger. Preincubation of the extracts with several glycohydrolases revealed that pretreatment with beta-glucosidase considerably reinforced the inhibition. A significant reduction of acetate incorporation was found above extract concentrations of 0.01 mg/mL and at 0.2 mg/mL almost 60% inhibition was observed. Cytotoxic effects detected by the MTT-assay were restricted to higher concentrations of the extracts with and without beta-glucosidase pretreatment. Since cynaroside represents a major glucoside in artichoke extracts, both cynaroside and its aglycone luteolin were tested. It could be demonstrated that cynaroside is indeed one of the targets of beta-glucosidase and that the liberated luteolin is responsible for the inhibitory effect. Direct measurements of beta-glucosidase activity in rat hepatocytes and HepG2 cells revealed that endogenous enzyme activity in hepatocytes may be sufficient to convert cynaroside to its aglycone, while in HepG2 cells this may not be the case. These findings emphasize the importance of beta-glucosidase-dependent liberation of luteolin for the ability of artichoke extracts to inhibit hepatic cholesterol biosynthesis. Copyright 2002 John Wiley & Sons, Ltd.

The combined effect of ochratoxin A (at diet levels of 130, 305 and 790 ppb) and penicillic acid was studied in 100 broiler chicks. Serological investigations revealed significantly lower haemagglutination inhibiting antibody titers in the experimental chicks immunized with vaccine against Newcastle disease. A statistically significant decrease of the body weight and the relative weight of lymphoid organs as well as a significant increase of the relative weight of kidneys and liver were seen. The main degenerative changes were observed in the proximal convoluted tubules in kidneys and slight degenerative changes were found in the hepatocytes. Degenerative changes and depletion of lymphoid cells were observed in the bursa Fabricii, thymus, spleen and Peyer's patches of intestinal mucosa. Serum analyses revealed significant decreases of the total protein and cholesterol, and significant increases of the uric acid and glucose. Haematological analyses showed a slight anaemia, leucocytosis and slightly decompensated metabolic acidosis. A statistically significant protective effect of 5% total water extract of artichoke on humoral immune response (increase of haemaglutination inhibiting antibody titer), relative organ weight as well as on pathomorphological, haematological and biochemical changes induced by ochratoxin A, was established.

BACKGROUND AND AIM: Clinical evidence exists for LDL-cholesterol lowering by plant sterols, bergamot extract and artichoke leaf extract individually but their effect when combined is unknown. This study investigated the effects of a novel nutraceutical combining plant sterols, bergamot extract, artichoke leaf extract and hydroxytyrosol (referred to as 'Cholesterol Balance'), on serum LDL-cholesterol (primary outcome), other cardiometabolic and oxidative stress markers in adults with hypercholesterolaemia. METHODS: Healthy adults (n = 42, 18-<66 years, body mass index [BMI] >18.5-<35 kg/m2), with mild hypercholesterolaemia (LDL-cholesterol ≥2.5-<5 mmol/L) and low CVD risk participated in a 4-month double-blind randomised placebo-controlled trial. Participants consumed either 3 capsules/day Cholesterol Balance (providing 375 mg Bergavit40™, 150 mg Altilix™, 1.8 g phytosterols, and 50 mg of Hydrovas10™ daily) or placebo. Outcomes were assessed at baseline, 2- and 4-months. RESULTS: There was no evidence that Cholesterol Balance affected serum LDL-cholesterol compared to placebo (adjusted mean difference [95 % CI] at 4 months between treatments, -0.12 [-0.34, 0.11] mmol/L, p = 0.307). None of the secondary outcomes, including total cholesterol, HDL-cholesterol, triglycerides, non-HDL-cholesterol, total cholesterol:HDL-cholesterol ratio, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), ApoB:ApoA1 ratio, plasma oxidised LDL, serum malondialdehyde, HbA1c, blood pressure or safety markers showed a significant difference between groups. CONCLUSION: While safe to consume, a nutraceutical containing plant sterols, bergamot extract, artichoke leaf extract and hydroxytyrosol did not show evidence of improving serum LDL-cholesterol, or any other lipid and oxidative stress markers in adults with mild hypercholesterolaemia. Further research is needed to determine if ingredients in the complex formulation interact or interfere with LDL-cholesterol lowering mechanisms.

BACKGROUND AND OBJECTIVES: Gut dysbiosis that resulted from the alteration between host-microbe interaction might worsen obesity-induced systemic inflammation. Gut microbiota manipulation by supplementation of prebiotic inulin may reverse metabolic abnormalities and improve obesity. This study aimed to determine whether inulin supplementation improved intestinal microbiota and microbial functional pathways in children with obesity. METHODS: Children with obesity whose BMI above median + 2SDs were recruited to a randomized, double-blinded placebo-controlled study. The participants aged 7-15 years were assigned to inulin supplement extracted from Thai Jerusalem artichoke (intervention), maltodextrin (placebo), and dietary fiber advice groups. All participants received similar monthly conventional advice and follow-up for 6 months. Fecal samples were collected for gut microbiome analysis using 16S rRNA sequencing. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States was performed to infer microbial functional pathways. RESULTS: One hundred and forty-three children with available taxonomic and functional pathway abundance profiles were evaluated. A significant increase in alpha-diversity was observed in the inulin group. Inulin supplementation substantially enhanced Bifidobacterium, Blautia, Megasphaera, and several butyrate-producing bacteria, including Agathobacter, Eubacterium coprostanoligenes, and Subdoligranulum, compared to the other groups. The inulin group showed a significant difference in functional pathways of proteasome and riboflavin metabolism. These changes correlated with clinical and metabolic outcomes exclusively in the inulin group. CONCLUSIONS: Inulin supplementation significantly promoted gut bacterial diversity and improved gut microbiota dysbiosis in children with obesity. The modulation of functional pathways by inulin suggests its potential to establish beneficial interactions between the gut microbiota and host physiology. Inulin supplementation could be a strategic treatment to restore the balance of intestinal microbiota and regulate their functions in childhood obesity. © 2024. The Author(s).

The aim of this study was to assess whether dietary supplementation with a nutraceutical blend comprising extracts of bergamot and artichoke-both standardized in their characteristic polyphenolic fractions-could positively affect serum lipid concentration and insulin sensitivity, high-sensitivity C-reactive protein (hs-CRP), and indexes of non-alcoholic fatty liver disease (NAFLD) in 90 healthy individuals with suboptimal cholesterol levels. Participants were randomly allocated to treatment with a pill of either active treatment or placebo. After 6 weeks, the active-treated group experienced significant improvements in levels of triglycerides (TG), apolipoprotein B-100 (Apo B-100), and apolipoprotein AI (Apo AI) versus baseline. Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high density lipoprotein cholesterol (Non-HDL-C), and hs-CRP also significantly decreased in the active-treated group compared to both baseline and placebo. At the 12-week follow-up, individuals allocated to the combined nutraceutical experienced a significant improvement in TC, LDL-C, Non-HDL-C, TG, Apo B-100, Apo AI, glucose, alanine transaminase (ALT), gamma-glutamyl transferase (gGT), hs-CRP, several indexes of NAFLD, and brachial pulse volume (PV) in comparison with baseline. Improvements in TC, LDL-C, Non-HDL-C, TG, fatty liver index (FLI), hs-CRP, and endothelial reactivity were also detected compared to placebo (p < 0.05 for all). Overall, these findings support the use of the tested dietary supplement containing dry extracts of bergamot and artichoke as a safe and effective approach for the prevention and management of a broad spectrum of cardiometabolic disorders.

INTRODUCTION: There is growing interest in head-to-head comparison between different lipid-lowering nutraceuticals. The aim of our study was to test the lipid-lowering effect of dietary supplementation with low-dose monacolins from red yeast rice (2.8 mg per daily dose) combined with berberine (Armolipid Plus®) or highly standardized artichoke extract versus placebo. MATERIAL AND METHODS: 60 overall healthy adult volunteers with polygenic hypercholesterolemia (baseline low-density lipoprotein cholesterol (LDL-C) = 160.2 ±9.2 mg/dl) were enrolled in a 3-arm, double-blind, non-inferiority, randomized, parallel-group clinical trial. After 4-week diet standardization, enrolled individuals were randomized to be treated for 8 weeks with red yeast rice and highly standardized artichoke extracts (ATC group), Armolipid Plus®, or placebo. RESULTS: At the enrolment visit, LDL-C values were similar in the compared groups. After 8 weeks, all actively treated subjects experienced significant improvements in baseline total cholesterol (TC), LDL-C and apolipoprotein B (Apo-B) (all p < 0.01) (ATC group: TC = -18.9%, LDL-C = -26.7% (placebo-corrected: -12.4%), Apo-B = -19.6%; Armolipid Plus®: TC = -18.4%, LDL-C = -25.8% (placebo-corrected: -12.1%), Apo-B = -23.2%; placebo: TC = -6.2%, LDL-C = -8%, Apo-B = -8.4%). Participants in the ATC group attained significantly lower body mass index (BMI) values (-2.1%), while individuals treated with Armolipid Plus® showed improvements in baseline high-density lipoprotein cholesterol (HDL-C) (+8.7%) and triglyceride (TG) (+17.5%) levels. Finally, baseline hepatic steatosis index (HSI) values significantly decreased in both actively treated groups (by -2.4% and -2.4% in ATC and in Armolipid Plus®, respectively). CONCLUSIONS: Patients with polygenic hypercholesterolemia experienced a significant improvement in several cardiovascular risk factors in both ATC and Armolipid Plus® groups. Copyright: © 2023 Termedia & Banach.

Inulin might improve body composition in obese children. We aimed to determine the effects of inulin supplementation on body composition and metabolic outcomes in obese children. A randomized, double-blinded placebo-controlled study was conducted in obese Thai children aged 7-15 years. Participants were assigned to 3 treatment groups for 6 months: 13 g of extracted inulin powder from Thai Jerusalem artichoke, isocaloric maltodextrin, and dietary fiber advice groups. Body composition was assessed by bioelectrical impedance analysis. One-hundred and fifty-five children completed the study (mean age 10.4 ± 2.2 years, BMI z-score 3.2 ± 1.0, 59% male). The drop-out rate was 6%. The inulin extract yielded more than 90% compliance without significant gastrointestinal side effects. All three groups demonstrated a significant decrease in BMI z-score, fat mass index (FMI), and trunk FMI, but the differences between groups were not observed. Fat-free mass index significantly increased only in the inulin group (16.18 ± 1.90 vs. 16.38 ± 1.98 kg/m2, P = 0.009). There were no significant differences in the metabolic profiles between groups. Despite showing no substantial effect on adiposity, inulin may increase fat-free mass in obese children. Further research in the change of gut microbiota composition is needed to determine inulin's impact on host-microbe interaction in pediatric obesity. © 2022. The Author(s).

We aimed to evaluate if dietary supplementation with a nutraceutical compound (Eufortyn® Colesterolo Plus) containing standardized bergamot polyphenolic fraction phytosome (Vazguard®), artichoke extract (Pycrinil®), artichoke dry extract. (Cynara scolymus L.), Q10 phytosome(Ubiqosome®) and zinc, could positively affect serum lipids concentration, systemic inflammation and indexes of non-alcoholic fatty liver disease (NAFLD) in 60 healthy subjects with polygenic hypercholesterolemia. Participants were adhering to a low-fat, low-sodium Mediterranean diet for a month before being randomly allocated to 8-week treatment with 1 pill each day of either Eufortyn® Colesterolo Plus or placebo. Dietary supplementation with Eufortyn® Colesterolo Plus was associated with significant improvement in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), high-sensitivity C-reactive protein (hs-CRP) and endothelial reactivity (ER) in comparison with baseline, and with significant reductions in waist circumference, TC, LDL-C, LDL-C/HDL-C, lipid accumulation product and fatty liver index compared to placebo. The study shows that dietary supplementation with standardized bergamot polyphenolic fraction phytosome, artichoke extracts, Q10 phytosome and zinc safely exerts significant improvements in serum lipids, systemic inflammation, indexes of NAFLD and endothelial reactivity in healthy subjects with moderate hypercholesterolemia.

Botanicals are natural alternatives to pharmacological therapies that aim at reducing hypercholesterolemia. In this context, despite bergamot being effective in modulating lipid profile, some subjects failed to achieve a satisfactory response to supplementation. The aim of this study was to evaluate whether the association of 600 mg of bergamot phytosome® (from Citrus Bergamia Risso) and 100 mg of artichoke leaf standardized dry extract (from Cynara cardunculus L.) can be an alternative in patients with mild hypercholesterolemia who are poor responders to bergamot in a 2-month randomized placebo-controlled trial. Sixty overweight adults were randomized into two groups: 30 were supplemented and 30 received a placebo. The metabolic parameters and DXA body composition were evaluated at the start, after 30 and 60 days. Between the two groups, total and LDL cholesterol in the supplemented group (compared to placebo) showed significant decreases overtime. A significant reduction of waist circumference and visceral adipose tissue (VAT) was recorded in the supplemented group (compared to placebo), even in subjects who did not follow a low-calorie diet. In conclusion, the synergism between Citrus Bergamia polyphenols and Cynara cardunculus extracts may be an effective option and may potentially broaden the therapeutic role of botanicals in dyslipidemic patients.

Accumulating evidence regarding the effect of artichoke on lipid profile is equivocal. We updated a previous meta-analysis on the effect of artichoke extract supplementation on lipid profile and performed dose-response analysis. We searched PubMed, Scopus, Web of Science, and Cochrane Library from inception to June 2021 using relevant keywords. Papers from identified articles were collected. Two researchers rated the certainty in the estimates using the GRADE approach. Combining 15 effect sizes from 14 studies based on the random-effects analysis, we found that artichoke significantly reduced TG (weighed mean difference [WMD]: -17.01 mg/dl, 95% CI: -23.88, -10.13, p = .011), TC (WMD: -17.01 mg/dl, 95% CI: -23.88, -10.13, p < .001), and LDL-C (WMD: -17.48 mg/dl, 95%CI: -25.44, -9.53, p < .001). No significant effect of artichoke on HDL-C level was detected (WMD: 0.78 mg/dl, 95%CI: -0.93, 2.49, p = .371). Combining the two effect sizes revealed that artichoke juice supplementation significantly reduced TG (WMD: -3.34 mg/dl, 95%CI: -5.51, -1.17, p = .003), TC (WMD: -18.04 mg/dl, 95%CI: -20.30, -15.78, p < .001), LDL-C (WMD: -1.75 mg/dl, 95%CI: -3.02, -0.48, p = .007), and HDL-C levels (WMD: -4.21 mg/dl, 95%CI: -5.49, -2.93, p < .001). In conclusion, we found that artichoke supplementation may favor CVD prevention by acting in improving the lipid profile. © 2021 John Wiley & Sons Ltd.

Global prevalence of type 2 diabetes (T2D) is rising and may affect 700 million people by 2045. Totum-63 is a polyphenol-rich natural composition developed to reduce the risk of T2D. We first investigated the effects of Totum-63 supplementation in high-fat diet (HFD)-fed mice for up to 16 wk and thereafter assessed its safety and efficacy (2.5 g or 5 g per day) in 14 overweight men [mean age 51.5 yr, body mass index (BMI) 27.6 kg·m-2] for 4 wk. In HFD-fed mice, Totum-63 reduced body weight and fat mass gain, whereas lean mass was unchanged. Moreover, fecal energy excretion was higher in Totum-63-supplemented mice, suggesting a reduction of calorie absorption in the digestive tract. In the gut, metagenomic analyses of fecal microbiota revealed a partial restoration of HFD-induced microbial imbalance, as shown by principal coordinate analysis of microbiota composition. HFD-induced increase in HOMA-IR score was delayed in supplemented mice, and insulin response to an oral glucose tolerance test was significantly reduced, suggesting that Totum-63 may prevent HFD-related impairments in glucose homeostasis. Interestingly, these improvements could be linked to restored insulin signaling in subcutaneous adipose tissue and soleus muscle. In the liver, HFD-induced steatosis was reduced by 40% (as shown by triglyceride content). In the subsequent study in men, Totum-63 (5 g·day-1) improved glucose and insulin responses to a high-carbohydrate breakfast test (84% kcal carbohydrates). It was well tolerated, with no clinically significant adverse events reported. Collectively, these data suggest that Totum-63 could improve glucose homeostasis in both HFD-fed mice and overweight individuals, presumably through a multitargeted action on different metabolic organs.NEW & NOTEWORTHY Totum-63 is a novel polyphenol-rich natural composition developed to reduce the risk of T2D. Totum-63 showed beneficial effects on glucose homeostasis in HFD-fed mice, presumably through a multitargeted action on different metabolic organs. Totum-63 was well tolerated in humans and improved postprandial glucose and insulin responses to a high-carbohydrate breakfast test.

Plant-based diets rich in bioactive compounds such as polyphenols have been shown to positively modulate the risk of cardiometabolic (CM) diseases. The inter-individual variability in the response to these bioactives may affect the findings. This systematic review aimed to summarize findings from existing randomized clinical trials (RCTs) evaluating the effect of hydroxycinnamic acids (HCAs) on markers of CM health in humans. Literature searches were performed in PubMed and the Web of Science. RCTs on acute and chronic supplementation of HCA-rich foods/extracts on CM biomarkers were included. Forty-four RCTs (21 acute and 23 chronic) met inclusion criteria. Comparisons were made between RCTs, including assessments based on population health status. Of the 44 RCTs, only seven performed analyses on a factor exploring inter-individual response to HCA consumption. Results demonstrated that health status is a potentially important effect modifier as RCTs with higher baseline cholesterol, blood pressure and glycaemia demonstrated greater overall effectiveness, which was also found in studies where specific subgroup analyses were performed. Thus, the effect of HCAs on CM risk factors may be greater in individuals at higher CM risk, although future studies in these populations are needed, including those on other potential determinants of inter-individual variability. PROSPERO, registration number CRD42016050790.

Our double-blind, placebo-controlled, parallel-group, dose-escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120-mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active-treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low-density lipoprotein cholesterol (LDL-C) versus baseline and placebo treatments. In the high-dose-treated group, also total cholesterol (TC), nonhigh-density lipoprotein cholesterol (non-HDL-C), γ-glutamil transpeptidasi, high-sensitivity C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α) significantly decreased. At 24-week follow-up, TG levels maintained lower than baseline in all groups. All patients allocated to either low-dose or high-dose active treatment experienced a significant decrease in TG, LDL-C, and homeostatin model assessment of insulin resistance. In subjects taking high-dose active treatment, adiponectin significantly increased, whereas TC, non-HDL-C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs-CRP, and TNF-α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects. © 2019 John Wiley & Sons, Ltd.

Hypercholesterolemia represents one of the main reversible cardiovascular risk factors. In this pilot clinical trial, we have tested the short-term efficacy and safety of a new combined cholesterol-lowering nutraceutical containing artichoke dry extract and berberine at enhanced bioavailability in subjects with moderate polygenic hypercholesterolemia in primary prevention for cardiovascular disease. After 2 months of treatment, the tested nutraceutical induced a significant reduction in plasma total cholesterol (-19%), low-density lipoprotein cholesterol (-16%), non-high-density lipoprotein cholesterol (-19%) and triglyceride levels (-15%), in association with a standardized control diet. No side effect has been observed during the trial. In conclusion, on the short-term, the tested nutraceutical has been shown to be well tolerated and effective, even if not containing any statin-like compound.

BACKGROUND: Transcription factor 7-like 2 (TCF7L2)-rs7903146 polymorphism is associated with increased risk of type 2 diabetes. The response of insulin and insulin resistance to artichoke leaf extract (ALE) may be affected by TCF7L2-rs7903146 polymorphism. OBJECTIVE: This study examined the effects of ALE supplementation on metabolic parameters of the TCF7L2-rs7903146 polymorphism in patients with metabolic syndrome (MetS). DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This double-blind clinical trial was conducted on 80 patients with MetS in Sina Clinic, Khoy, Iran. The patients were randomized into ALE or placebo groups to receive either ALE (1800 mg/d as four tablets) or matching placebo for 12 weeks. MAIN OUTCOME MEASURES: Anthropometric indices, blood pressure, glucose and lipid profile levels were measured before and after the study. Moreover, patients were genotyped for TCF7L2 polymorphism. RESULTS: ALE supplementation decreased insulin level and the homeostasis model assessment of insulin resistance (HOMA-IR) in patients with the TT genotype of TCF7L2-rs7903146 polymorphism (P < 0.05). There was no significant interaction between blood pressure, glucose and lipid profile response to ALE supplementation. CONCLUSION: The responses of insulin and HOMA-IR to ALE supplementation have shown an interaction with single-nucleotide polymorphism rs7903146 in TCF7L2. TRIAL REGISTRATION: Iranian Registry of Clinical Trial IRCT201409033320N9.