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

Babish, John G.; Dahlberg, Clinton J.; Ou, Joseph J.; Keller, William J.; Gao, Wei; Kaadige, Mohan R.; Brabazon, Holly; Lamb, Joseph; Soudah, Hani C.; Kou, Xiaolan; Zhang, Zhe; Pacioretty, Linda M.; Tripp, Matthew L.

doi:10.1139/cjpp-2016-0062

Cited by 17 publications

(18 citation statements)

References 52 publications

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“…The study carried out by Cai et al (2017) did not find statistically significant differences. Even though, it is important to note that Babish et al (2016), Bruno, Pandolfo, Crucitti, Cacciola, et al (2017) and Dahlberg et al (2017) showed light although significant decreases in HDL cholesterol concentration, that ranged from 1% to 6.5%.…”

Section: Change On Lipid Profilementioning

confidence: 94%

“…There was quite heterogeneity in clinical characteristics of populations. In summary, two trials recruited subjects with overweight or obesity and other cardiovascular risk factors (Dahlberg et al 2017) or metabolic syndrome (Di Folco et al 2018), four trials included subjects with mixed hyperlipidemia (Gliozzi et al 2013; Mollace et al 2011;Cai et al 2017;Babish et al 2016), one trial involved subjects with isolated hypercholesterolemia (Toth et al 2015), one trial recruited participants with previous ischemic heart disease (Campolongo et al 2016), two similar trials recruited subjects under second-generation antipsychotics (SGA) treatment (Bruno, Pandolfo, Crucitti, Cacciola, et al 2017;Bruno, Pandolfo, Crucitti, Maisano, et al 2017), and one trial included women with breast cancer and receiving aromatase inhibitors treatment (Izzo et al 2017). Five studies had a single-arm intervention, while six of them showed double or multiple-arm designs by comparing different doses of bergamot, using a placebo or statin group as comparison arm.…”

Section: Participants and Main Study Characteristicsmentioning

confidence: 99%

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Effect of bergamot on lipid profile in humans: A systematic review

Lamíquiz-Moneo

Giné-Gonzalez

Alisente

et al. 2019

Critical Reviews in Food Science and Nutrition

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Dyslipidemia is a well-established modifiable cardiovascular risk. Although statins can reduce LDLc by 50-60%, less than 20% of patients with high risk of CVD achieve LDL targets. The aim of this systematic review is to evaluate the effect of the nutraceutical, bergamot (Citrus bergamia), on lipid parameters in humans. PubMed, Embase, Cochrane Library, and Google Scholar databases were searched for interventional and observational studies investigating the effect of bergamot on lipid profile in humans. This systematic review retrieved a total of 442 studies of which 12 articles fulfilled the eligibility criteria and were included in the qualitative synthesis. Based on data, 75% of studies showed a significant decrease in total cholesterol, triglycerides and LDLc. The decrease in total cholesterol varied from 12.3% to 31.3%, from 7.6% to 40.8% in LDLc and from 11.5% to 39.5% in triglycerides. Eight trials reported HDLc increase after intervention with bergamot. Overall, a dose-dependent and possible synergistic effect when administering with statins can be deducted from these trials. It is essential to point out that studies had heterogeneous designs and scientific quality of studies was quite limited. Promising findings reveal an alternative therapeutic option in dyslipidemia management with bergamot supplementation, especially in subjects with statins intolerance.

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Section: Change On Lipid Profilementioning

confidence: 94%

Section: Participants and Main Study Characteristicsmentioning

confidence: 99%

Effect of bergamot on lipid profile in humans: A systematic review

Lamíquiz-Moneo

Giné-Gonzalez

Alisente

et al. 2019

Critical Reviews in Food Science and Nutrition

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“…In 2016, (Babish et al (2016) showed that a 250 mg dose of bergamot fruit extract (BFE) and 110 mg of a blend of nine other phytoextracts showed a decrease in total cholesterol, LDL, and apolipoprotein B (p < 0.05). A post hoc analysis showed other significant effects only in eight subjects with HbA1c > 5.4 and HOMA-IR score >2 or elevated triglycerides: reduction in triglycerides and plasminogen activator inhibitor type 1 (PAI-1) (p < 0.05).…”

Section: Effects On Humansmentioning

confidence: 99%

“…Although native to South-East Asia, 80% of bergamot is produced in Calabria, southern Italy, where it grows extensively. The main preparations used are bergamot extracts (BE), with high content of flavonoids, such as neoeriocitrin, neohesperidin, naringin (Toth et al, 2015), bergamot polyphenolic fraction (BPF) (Bruno, Pandolfo, Crucitti, Maisano, Zoccali, et al, 2017), bergamot essential oil (BEO) (Watanabe et al, 2015), and aromasticks with bergamot/sandalwood or frankincense/mandarin/lavender (Dyer, Cleary, McNeill, Ragsdale-Lowe, & Osland, 2016) bergamot/vetivert/geranium (Wiebe, 1998), bergamot/lavender/cedarwood (Graham, Browne, Cox, & Graham, 2003) and bergamot juice (BJ) (Impellizzeri et al, 2015), bergamot/boxthorn extract (Shao, 2003) or bergamot essential oil plus other citrus essential oils plus grapefruit juice (Li, Zhu, Han, & Zhang, 2016) or bergamot flavonoids and other phytoextracts (Babish et al, 2016;Saiyudthong & Marsden, 2011). Bergamot essential oil (BEO) and bergamot juice (BJ) contain up to 93-96% of volatile compounds, such as monoterpenes (25-53% of limonene), as well as discrete quantities of linalool (2-20%) and linalyl acetate (15-40%).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of bergamot: From anti‐inflammatory and anti‐oxidative mechanisms to clinical applications as preventive agent for cardiovascular morbidity, skin diseases, and mood alterations

Perna

Spadaccini

Botteri

et al. 2019

Food Science & Nutrition

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We summarize the effects of bergamot (extract, juice, essential oil, and polyphenolic fraction) on cardiovascular, bone, inflammatory, skin diseases, mood alteration, anxiety, pain, and stress. This review included a total of 31 studies (20 studies on humans with 1709 subjects and 11 in animals (rats and mice)). In humans, bergamot‐derived extract (BE) exerts positive effects on hyperlipidemia with an oral dose from 150 mg to 1000 mg/day of flavonoids administered from 30 to 180 days, demonstrating an effect on body weight and in modulating total cholesterol, triglycerides, LDL, and HDL. Studies in animals confirm promising data on glucose control (500/1000 mg/day of BE with a treatment lasting 30 days) are available in rats. In animals models, bergamot essential oil (BEO, 10 mg/kg or 20 mg/kg daily for 20 weeks) increases bone volume, decreases psoriatic plaques, increases skin collagen content, and promotes hair growth. Bergamot juice (20 mg/kg) is promising in terms of pro‐inflammatory cytokine reduction. In humans, aromatherapy (from 15 to 30 min) does not appear to be useful in order to reduce stress, anxiety, and nausea, compared to placebo. Compared to baseline, BE topical application and BEO aromatherapy reduce blood diastolic and systolic pressure and could have a significant effect on improving mental conditions.

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“…Obesity is a potent risk factor for kidney disease, as obese subjects have a greater chance of developing diseases such as diabetes and hypertension [68]. Several studies have also shown that being overweight or obese may directly cause renal dysfunction and kidney damage through a direct role in the endocrine activity of adipose tissue [71][72][73][74]. Indeed, many adipokines that are produced by higher visceral adipose tissue have been involved in the development of insulin resistance, inflammation, and oxidative stress [65,68,75,76].…”

Section: Oxidative Stress and Chronic Kidney Diseasementioning

confidence: 99%

Oxidative Imbalance and Kidney Damage: New Study Perspectives from Animal Models to Hospitalized Patients

2019

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Chronic kidney disease (CKD) is a major public health problem worldwide and affects both elderly and young subjects. Its main consequences include the loss of renal function, leading to end-stage renal disease, an increased risk of cardiovascular disease, a significant increase in morbidity and mortality, and a decrease in health-related quality of life. This review arose in significant part from work in the authors’ laboratory, complemented by literature data, and was based on a translational approach: we studied the role of many CKD risk factors, such as hypertension, obesity, and oxidative stress/inflammation. The aim was to identify new molecular mechanisms of kidney damage to prevent it through successful behavior modifications. For this purpose, in our studies, both human and animal models were used. In the animal models, we analyzed the mechanisms of renal damage induced by hypertension (spontaneously hypertensive rats) and obesity (cafeteria diet-fed rats), showing that redox disequilibrium in plasma and tissue is extremely important in renal alteration in terms of both oxidative damage (lipid peroxidation, altered expression antioxidant enzymes) and apoptotic pathway (intrinsic/extrinsic) activation. In hemodialysis patients, we explored the correlation between the global oxidative balance and both inflammatory markers and cardiovascular risk, showing a strong correlation between the oxidative index and the blood levels of C-reactive protein and previous cardiovascular events. This multilevel approach allowed us to individually and synergistically analyze some aspects of the complex pathogenic mechanisms of CKD in order to clarify the role of the new amplified risk factors for CKD and to prepare an effective personalized prevention plan by acting on both modifiable and nonmodifiable risk factors.

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

Cited by 17 publications

References 52 publications

Effect of bergamot on lipid profile in humans: A systematic review

Effect of bergamot on lipid profile in humans: A systematic review

Efficacy of bergamot: From anti‐inflammatory and anti‐oxidative mechanisms to clinical applications as preventive agent for cardiovascular morbidity, skin diseases, and mood alterations

Oxidative Imbalance and Kidney Damage: New Study Perspectives from Animal Models to Hospitalized Patients

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