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Phase II prospective randomized trial of weight loss prior to radical prostatectomy.
Henning, SM, Galet, C, Gollapudi, K, Byrd, JB, Liang, P, Li, Z, Grogan, T, Elashoff, D, Magyar, CE, Said, J, et al
Prostate cancer and prostatic diseases. 2018;(2):212-220
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Abstract
BACKGROUND Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. METHODS In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. RESULTS In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. CONCLUSIONS In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant epithelium apoptosis or proliferation. Future studies should consider a longer term or more intensive weight loss intervention.
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Pistachio nuts reduce triglycerides and body weight by comparison to refined carbohydrate snack in obese subjects on a 12-week weight loss program.
Li, Z, Song, R, Nguyen, C, Zerlin, A, Karp, H, Naowamondhol, K, Thames, G, Gao, K, Li, L, Tseng, CH, et al
Journal of the American College of Nutrition. 2010;(3):198-203
Abstract
OBJECTIVE There is a widely held view that, due to high fat content, snacking on nuts will lead to weight gain, ultimately causing unhealthy changes in lipid profiles. This study is designed to study the effects of pistachio snack consumption on body weight and lipid levels in obese participants under real-world conditions. METHODS Participants were randomly assigned to consume 1 of 2 isocaloric weight reduction diets for 12 weeks, with each providing 500 cal per day less than resting metabolic rate. Each diet included an afternoon snack of either 53 g (240 cal) of salted pistachios (n = 31) or 56 g of salted pretzels (220 cal; n = 28). RESULTS Both groups lost weight during the 12-week study (time trend, p < 0.001), but there were significant differences in the changes in body mass index between the pretzel and pistachio groups (pistachio, 30.1 ± 0.4 to 28.8 ± 0.4 vs. pretzel, 30.9 ± 0.4 to 30.3 ± 0.5). At 6 and 12 weeks, triglycerides were significantly lower in the pistachio group compared with the pretzel group (88.04 ± 9.80 mg/dL vs. 144.56 ± 18.86 mg/dL, p = 0.01 at 6 weeks and 88.10 ± 6.78 mg/dL vs. 132.15 ± 16.76 mg/dL, p = 0.02 at 12 weeks), and there was a time trend difference between the 2 groups over the 12 weeks (p < 0.01). There were no significant differences in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, insulin, or glucose between the 2 groups. CONCLUSION Pistachios can be consumed as a portion-controlled snack for individuals restricting calories to lose weight without concern that pistachios will cause weight gain. By comparison to refined carbohydrate snacks such as pretzels, pistachios may have beneficial effects on triglycerides as well.
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Safety and antioxidant activity of a pomegranate ellagitannin-enriched polyphenol dietary supplement in overweight individuals with increased waist size.
Heber, D, Seeram, NP, Wyatt, H, Henning, SM, Zhang, Y, Ogden, LG, Dreher, M, Hill, JO
Journal of agricultural and food chemistry. 2007;(24):10050-4
Abstract
The consumption of pomegranate juice (PJ), a rich source of antioxidant polyphenols, has grown tremendously due to its reported health benefits. Pomegranate extracts, which incorporate the major antioxidants found in pomegranates, namely, ellagitannins, have been developed as botanical dietary supplements to provide an alternative convenient form for consuming the bioactive polyphenols found in PJ. Despite the commercial availability of pomegranate extract dietary supplements, there have been no studies evaluating their safety in human subjects. A pomegranate ellagitannin-enriched polyphenol extract (POMx) was prepared for dietary supplement use and evaluated in two pilot clinical studies. Study 1 was designed for safety assessment in 64 overweight individuals with increased waist size. The subjects consumed either one or two POMx capsules per day providing 710 mg (435 mg of gallic acid equivalents, GAEs) or 1420 mg (870 mg of GAEs) of extracts, respectively, and placebo (0 mg of GAEs). Safety laboratory determinations, including complete blood count (CBC), chemistry, and urinalysis, were made at each of three visits. Study 2 was designed for antioxidant activity assessment in 22 overweight subjects by administration of two POMx capsules per day providing 1000 mg (610 mg of GAEs) of extract versus baseline measurements. Measurement of antioxidant activity as evidenced by thiobarbituric acid reactive substances (TBARS) in plasma were measured before and after POMx supplementation. There was evidence of antioxidant activity through a significant reduction in TBARS linked with cardiovascular disease risk. There were no serious adverse events in any subject studied at either site. These studies demonstrate the safety of a pomegranate ellagitannin-enriched polyphenol dietary supplement in humans and provide evidence of antioxidant activity in humans.