Optimizing Fertility Treatment With Nutrition Guidance: Exploring Barriers and Facilitators to Healthful Nutrition Among Female Cancer Survivors With Fertility Challenges.

INTRODUCTION: Young women diagnosed with cancer are at an increased risk for infertility compared to women without a cancer diagnosis. Consuming a healthful diet comprised of whole grains, fruits, vegetables, and unsaturated fats has been found to improve both fertility and cancer survivorship. Given this reason, dietary interventions tailored to support female cancer survivors with fertility challenges are of immense importance. Therefore, the aim of this study was to explore barriers and facilitators to healthful nutrition among female cancer survivors with fertility challenges, to inform the development of dietary interventions for this population. METHODS: Using a formative research design, interview, survey, and dietary intake data were collected from 20 female cancer survivors of reproductive age. Participant-check focus group discussions were conducted to validate findings. All interviews were recorded and transcribed verbatim. Transcripts were coded and analyzed using a thematic analysis approach. Quantitative data were analyzed using means, standard deviations, ranges, frequencies, and percentages. RESULTS: The average age of respondents was 31.47 ± 3.5 years and the average BMI was 24.78 ± 4.1 kg/m2. All participants were college educated, 45% identified as White, 50% as Black, and 10% as Hispanic or Latinx. Cancer diagnoses included breast, thyroid, ovarian, leukemia, and gastrointestinal cancers. The following themes were identified: (1) Lack of nutrition-related resources and detailed guidance, (2) Work-life balance, (3) Perceived rigidity of dietary guidance, (4) Treatment-related fatigue, (5) Having trust in healthcare providers, (6) Higher motivation to change nutrition behavior, and (7) Recognizing the additional benefits of nutrition. CONCLUSION: These findings indicate a sought-after yet unmet need for post-cancer treatment fertility nutrition recommendations. Interventions should be tailored to women's needs and focus on improving their self-efficacy to make healthful dietary choices.

Association between selenium intake and breast cancer risk: results from the Women's Health Initiative.

PURPOSE: It has been hypothesized that selenium (Se) can prevent cancer, and that Se deficiency may be associated with an increased risk of breast cancer. However, findings from epidemiological studies have been inconsistent. The objective of this study was to assess the association between Se intake and risk of breast cancer in the Women's Health Initiative (WHI). METHODS: This study included 145,033 postmenopausal women 50-79 years who completed baseline questionnaires between October 1993 and December 1998, which addressed dietary and supplemental Se intake and breast cancer risk factors. The association between baseline Se intake and incident breast cancer was examined in Cox proportional hazards analysis. RESULTS: During a mean follow-up of 15.5 years, 9487 cases of invasive breast cancer were identified. Total Se (highest versus lowest quartile: HR 1.00, 95% CI 0.92-1.09, Ptrend = 0.66), dietary Se (highest versus lowest quartile: HR 0.99, 95% CI 0.89-1.08, Ptrend = 0.61), and supplemental Se (yes versus no: HR 0.99, 95% CI 0.95-1.03) were not associated with breast cancer incidence. CONCLUSIONS: This study indicates that Se intake is not associated with incident breast cancer among postmenopausal women in the United States. Further studies are needed to confirm our findings by using biomarkers such as toenail Se to reduce the potential for misclassification of Se status.

Associations of social, physical, and financial factors with diet quality among older, community-dwelling women.

OBJECTIVE: This analysis examined whether specific social, physical, and financial factors were associated with diet quality among older, community-dwelling women. METHODS: This cross-sectional analysis was conducted in a subset of 6,094 community-dwelling Women's Health Initiative participants who completed a food frequency questionnaire, administered from 2012 to 2013, and a self-administered supplemental questionnaire, administered approximately 1 year later. The supplemental questionnaire included five questions assessing social, physical, and financial factors related to eating. Diet quality was assessed with the Healthy Eating Index-2010 (HEI-2010; range of 0-100; higher score indicates a higher quality diet). The total HEI-2010 score was calculated by summing individual scores representing the intake of nine adequacy components (beneficial food groups) and three moderation components (food groups to limit). Associations of responses to the five questions on the supplemental questionnaire with HEI-2010 scores were examined with multiple linear regression, adjusting for relevant covariates. RESULTS: Mean ±â€Šstandard deviation age of participants was 78.8 ±â€Š6.7 years. Reporting eating fewer than two meals per day, having dental or other mouth problems causing problems with eating, and not always being able to shop, cook, or feed oneself were associated with statistically significantly lower HEI-2010 scores, compared with those not reporting these issues, after multivariable adjustment: 5.37, 2.98, and 2.39 lower scores, respectively (all P values <0.0001). Reporting eating alone most of the time and not always having enough money to buy food were not associated with HEI-2010 scores. CONCLUSIONS: Among older, community-dwelling women, eating fewer than two meals per day, dental and other mouth problems, and diminished ability to shop for food, prepare meals, and feed oneself were associated with lower diet quality. These are potential targets for interventions to improve diet quality in older women. : Video Summary:http://links.lww.com/MENO/A561.

Video Summary:http://links.lww.com/MENO/A561.

Vitamin D with calcium supplementation and risk of atrial fibrillation in postmenopausal women.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia in adults. Although vitamin D deficiency is associated with AF risk factors, retrospective studies of association with AF have shown mixed results. We sought to determine the efficacy of calcium and vitamin D (CaD) supplementation for AF prevention in a randomized trial. METHODS: We performed a secondary analysis of the Women's Health Initiative trial on CaD supplementation versus placebo. We linked participants to their Medicare claims to ascertain incident AF. RESULTS: Among 16,801 included participants, there were 1,453 (8.6%) cases of incident AF over an average of 4.5 years, at an average rate of 19.9 events per 1,000 person-years. We found no significant difference in incident AF rates between the CaD and placebo arms (hazard ratio 1.02 for CaD vs placebo, 95% CI 0.92-1.13). After multivariate adjustment, there was no significant association between baseline 25-hydroxyvitamin D serum levels and incident AF (hazard ratio 0.92 for lowest subgroup vs highest subgroup, 95% CI 0.66-1.28). CONCLUSIONS: We present the first analysis of a large randomized trial of daily vitamin D supplementation for AF prevention. We found that CaD had no effect on incidence of AF in Women's Health Initiative CaD trial participants. We also found that baseline serum 25-hydroxyvitamin D level was not predictive of long-term incident AF risk.

Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol.

PURPOSE: Women with breast cancer were randomized to receive coenzyme Q10 (CoQ10) plus Vitamin E or placebo in a clinical trial. The objective of this evaluation is to examine the association between participant self-reported adherence to the study supplements and changes in plasma biomarker levels. PATIENTS AND METHODS: Correlation coefficients quantified the association between changes in alpha-tocopherol and CoQ10 levels and the association between self-reported adherence and changes in biomarkers. Participants were categorized by self-reported adherence; Kruskal- Wallis tests compared changes in alpha-tocopherol and CoQ10 levels between self-reported adherence groups. RESULTS: Women (N=155) provided baseline and post-treatment biomarkers; 147 completed at least one diary. While changes in alpha-tocopherol and CoQ10 levels were moderately correlated, correlations ranged from 0.40 to 0.48, association between self-reported adherence and plasma alpha-tocopherol or CoQ10 levels was weak; correlations ranged from 0.10 to 0.29 at weeks 8, 16, and 24. Some participants with high self-reported adherence actually had decreases in their biomarker levels. CONCLUSION: These findings support that self-reported adherence is likely to be overestimated. Biological and other measures of adherence that can better identify true adherence to study pills provided in clinical trials are greatly needed as they may assist in improving the interpretation of findings of future clinical trials.

A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer.

BACKGROUND: Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs. RESULTS: After 12 weeks, patients on JP had significantly higher serum α-carotene ( P = .009), ß-carotene ( P < .0001), and lutein ( P = .003) but did not differ significantly in p27 ( P = .23) or Ki-67 ( P = .95). JP use following the initial 12-week trial was not significantly associated with SPT prevention. CONCLUSIONS: Despite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

Food Fortification and Supplement Use-Are There Health Implications?

UNLABELLED: Dietary supplements are a multi-billion dollar industry in the U.S., and their use is increasing exponentially. Additionally, many foods and beverages are increasingly being fortified with single or multiple vitamins and minerals. Consequently, nutrient intakes are exceeding the safe limits established by the Institute of Medicine. In this paper, we examine the benefits and drawbacks of vitamin and mineral supplements and increasing consumption of fortified foods (in addition to dietary intake) in the U.S. POPULATION: The pros and cons are illustrated using population estimates of folic acid, calcium, and vitamin D intake, highlighting concerns related to overconsumption of nutrients that should be addressed by regulatory agencies.

Cross-sectional analysis of calcium intake for associations with vascular calcification and mortality in individuals with type 2 diabetes from the Diabetes Heart Study.

BACKGROUND: The use of calcium supplements to prevent declines in bone mineral density and fractures is widespread in the United States, and thus reports of elevated cardiovascular disease (CVD) risk in users of calcium supplements are a major public health concern. Any elevation in CVD risk with calcium supplement use would be of particular concern in individuals with type 2 diabetes (T2D) because of increased risks of CVD and fractures observed in this population. OBJECTIVE: In this study, we examined associations between calcium intake from diet and supplements and measures of subclinical CVD (calcified plaque in the coronary artery, carotid artery, and abdominal aorta) and mortality in individuals affected by T2D. DESIGN: We performed a cross-sectional analysis in individuals affected by T2D from the family-based Diabetes Heart Study (n = 720). RESULTS: We observed no significant associations of calcium from diet or supplements with any of our measures of calcified plaque, and no greater mortality risk was observed with increased calcium intake. Instead, calcium supplement use was modestly associated with reduced all-cause mortality in women (HR: 0.62; 95% CI: 0.42, 0.92; P = 0.017). CONCLUSION: Our results do not support a substantial association between calcium intake from diet or supplements and CVD risk in individuals with T2D.

Calcium/vitamin D supplementation, serum 25-hydroxyvitamin D concentrations, and cholesterol profiles in the Women's Health Initiative calcium/vitamin D randomized trial.

OBJECTIVE: The objective of this study was to evaluate whether increased serum 25-hydroxyvitamin D3 (25OHD3) concentrations, in response to calcium/vitamin D (CaD) supplementation, are associated with improved lipids in postmenopausal women. METHODS: The parent trial was a double-blind, randomized, placebo-controlled, parallel-group trial designed to test the effects of CaD supplementation (1,000 mg of elemental calcium + 400 IU of vitamin D3 daily) versus placebo in postmenopausal women. Women from the general community, including multiple sites in the United States, were enrolled between 1993 and 1998. This cohort included 300 white, 200 African-American, and 100 Hispanic participants who were randomly selected from the Women's Health Initiative CaD trial. Serum 25OHD3 and lipid (fasting plasma triglycerides [TG], high-density lipoprotein cholesterol [HDL-C], and calculated low-density lipoprotein cholesterol [LDL-C]) levels were assessed before and after CaD randomization. RESULTS: There was a 38% increase in mean serum 25OHD3 concentrations after 2 years (95% CI, 1.29-1.47, P < 0.001) for women randomized to CaD (24.3 ng/mL postrandomization mean) compared with placebo (18.2 ng/mL). Women randomized to CaD had a 4.46-mg/dL mean decrease in LDL-C (P = 0.03). Higher concentrations of 25OHD3 were associated with higher HDL-C levels (P = 0.003), along with lower LDL-C and TG levels (P = 0.02 and P < 0.001, respectively). CONCLUSIONS: Supplemental CaD significantly increases 25OHD3 concentrations and decreases LDL-C. Women with higher 25OHD3 concentrations have more favorable lipid profiles, including increased HDL-C, lower LDL-C, and lower TG. These results support the hypothesis that higher concentrations of 25OHD3, in response to CaD supplementation, are associated with improved LDL-C.

Effects of tomato and soy on serum adipokine concentrations in postmenopausal women at increased breast cancer risk: a cross-over dietary intervention trial.

CONTEXT: Breast cancer risk among postmenopausal women increases as body mass index increases. Practical preventive methods to reduce risk of breast cancer are lacking. Few studies have investigated the effects of carotenoids and isoflavones on circulating adipokines in postmenopausal women. OBJECTIVE: The aim was to examine the effects of lycopene- and isoflavone-rich diets on serum adipokines. DESIGN: This was a 26-week, two-arm, longitudinal crossover trial. SETTING: Participants were recruited from clinics at The Ohio State University Comprehensive Cancer Center. PARTICIPANTS: Seventy postmenopausal women at increased breast cancer risk participated in the study. The mean age and body mass index of participants was 57.2 years and 30.0 kg/m(2), respectively; the study was comprised of 81.4% whites. INTERVENTIONS: The interventions included 10 weeks of consumption of a tomato-based diet (≥25 mg lycopene daily) and 10 weeks of consumption of a soy-based diet (≥40 g of soy protein daily), with a 2-week washout in between. MAIN OUTCOME MEASURES: Changes in serum adiponectin, leptin, and the adiponectin to leptin ratio were examined for each intervention through linear mixed models, with ratio estimates corresponding to postintervention adipokine concentrations relative to preintervention concentrations. RESULTS: After the tomato intervention, among all women, adiponectin concentration increased (ratio 1.09, 95% confidence interval (CI) 1.00-1.18), with a stronger effect observed among nonobese women (ratio 1.13, 95% CI 1.02-1.25). After the soy intervention, adiponectin decreased overall (ratio 0.91, 95% CI 0.84-0.97), with a larger reduction observed among nonobese women (ratio 0.89, 95% CI 0.81-0.98). Overall, no significant changes in leptin or the adiponectin to leptin ratio were observed after either intervention. CONCLUSIONS: Increasing dietary consumption of tomato-based foods may beneficially increase serum adiponectin concentrations among postmenopausal women at increased breast cancer risk, especially those who are not obese. Additional studies are essential to confirm these effects and to elucidate the specific mechanisms that may make phytonutrients found in tomatoes practical as breast cancer chemopreventive agents.

Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.

PURPOSE: Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men. PATIENTS AND METHODS: Eligible androgen-deprived men were randomly assigned to one of four daily regimens (2 × 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate. RESULTS: In all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL. CONCLUSION: In androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.

Plasma concentrations of trans fatty acids in persons with type 2 diabetes between September 2002 and April 2004.

BACKGROUND: transFatty acids (TFAs) increase cardiovascular disease risk. TFAs and polyunsaturated fatty acids (PUFAs) in the food supply may be declining with reciprocal increases in cis-monounsaturated fatty acids (MUFAs) and saturated fatty acids (SFAs). OBJECTIVES: We sought to determine whether plasma 18-carbon TFA and PUFA concentrations might decrease over time and whether there might be reciprocal increases in plasma cis-MUFAs and SFAs. DESIGN: We studied 305 persons (171 women) taking part in Look AHEAD (Action for Health in Diabetes), a randomized trial of lifestyle intervention for weight loss to reduce major cardiovascular events in overweight and obese adults (aged 45-76 y) with type 2 diabetes who also participated in an ancillary study of oxidative stress. This study was a cross-sectional analysis of TFAs, cis-MUFAs, SFAs, and PUFAs measured in plasma before intervention (September 2002-April 2004). RESULTS: In a model that included demographic characteristics, plasma total fatty acid concentration, BMI, serum insulin, statin use, season, and longitudinal time trend (R(2) = 0.167, P < 0.0001), plasma TFAs decreased by 13.5%/y (95% CI: -22.7, -3.2%/y; absolute decrease 7.0 mg · L(-1) · y(-1); 95% CI: -12.5, -1.6 mg · L(-1) · y(-1); P = 0.012). This longitudinal trend was not significantly altered by further adjustment for dietary variables and physical activity. In contrast, longitudinal trends for PUFAs, cis-MUFAs, and SFAs were weak and not significant. CONCLUSIONS: This change in plasma concentrations of TFAs is consistent with changes in fatty acid composition that food manufacturers are likely to have made to avoid declaring TFAs on food labels. Further research will be needed to determine the overall effect of these changes on cardiovascular risk. The Look AHEAD trial is registered at clinicaltrials.govas NCT00017953.

A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.

BACKGROUND: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. OBJECTIVES: We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. RESULTS: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). CONCLUSIONS: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

Dietary iron intake and serum ferritin concentration in 213 patients homozygous for the HFEC282Y hemochromatosis mutation.

BACKGROUND: HFEC282Y homozygotes have an increased risk for developing increased iron stores and related disorders. It is controversial whether dietary iron restrictions should be recommended to such individuals. OBJECTIVE: To determine whether dietary iron content influences iron stores in HFEC282Y homozygotes as assessed by serum ferritin concentration. DESIGN: Serum ferritin concentration was measured and a dietary iron questionnaire was completed as part of the evaluation of 213 HFEC282Y homozygotes who were identified through screening of >100,000 primary care patients at five HEmochromatosis and IRon Overload Screening (HEIRS) Study Field Centers in the United States and Canada. RESULTS: No significant relationships between serum ferritin concentration and dietary heme iron content, dietary nonheme iron content or reports of supplemental iron use were found. CONCLUSION: These results do not support recommending dietary heme or nonheme iron restrictions for HFEC282Y homozygotes diagnosed through screening in North America.

Intake of antioxidant nutrients and risk of non-Hodgkin's Lymphoma in the Women's Health Initiative.

Incidence rates of non-Hodgkin's lymphoma (NHL) increased substantially in the United States and worldwide during the latter part of the 20(th) century, but little is known about the etiology of this condition. Antioxidant nutrients may reduce the risk of NHL by quenching free radicals, which may contribute to carcinogenesis by damaging DNA and lipid membranes. We examined the association of intake of vitamin A and antioxidant nutrients with risk of NHL and its major subtypes in 1,104 cases of NHL identified among 154,363 postmenopausal women followed for an average of 11 yr in the Women's Health Initiative. Cox proportional hazards models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI). Of all nutrients examined, only total vitamin A intake (from diet and supplements combined) was inversely associated with risk of NHL overall (multivariate adjusted HR for highest vs. lowest quartile 0.83, 95% CI 0.69-0.99), whereas total vitamin C intake was inversely associated with risk of diffuse large B-cell lymphoma (HR for highest vs. lowest quartile 0.69, 95% CI 0.49-0.98). Overall, this study provides some evidence of inverse associations of intake of total vitamin A and total vitamin C with the risk of NHL and diffuse lymphoma, respectively.

Vitamin D and calcium supplementation and one-year change in mammographic density in the women's health initiative calcium and vitamin D trial.

BACKGROUND: Calcium and vitamin D may be inversely related to breast cancer risk, in part by affecting mammographic density. However, results from previous, mostly cross-sectional studies have been mixed, and there have been few randomized clinical trials of the effect of calcium and vitamin D supplementation on change in mammographic density. METHODS: We assessed the effect of one year of supplementation on mammographic density in 330 postmenopausal women enrolled in the Women's Health Initiative hormone therapy (HT) and calcium and vitamin D (CaD) trials. Women were randomized to receive 1,000 mg/d of elemental calcium carbonate plus 400 IU/d of vitamin D(3) or placebo. RESULTS: After approximately one year, mammographic density decreased 2% in the CaD supplementation group and increased 1% in the placebo group (ratio of means = 0.97; 95% CI = 0.81-1.17). Results suggested potential interaction by HT use (P = 0.08). Among women randomized to HT placebo, the ratio of mean density comparing CaD supplementation and placebo groups was 0.82 (95% CI = 0.61-1.11) vs. 1.16 (95% CI = 0.92-1.45) in women randomized to active HT. In sensitivity analyses limited to women taking ≥ 80% of study supplements, ratios were 0.67 (95% CI = 0.41-1.07) in women not assigned to HT and 1.07 (95% CI = 0.79-1.47) women assigned to HT. CONCLUSIONS: We observed no overall effect of vitamin D and calcium supplementation on mammographic density after one year. IMPACT: Potential interaction between these nutrients and estrogen as related to mammographic density warrants further study.

Soy protein based supplementation supports metabolic effects of resistance training in previously untrained middle aged males.

OBJECTIVE: To determine changes in body composition, physical performance, metabolic and hormonal parameters induced by lifestyle counselling, resistance training and resistance training with soy protein based supplemention in middle aged males. DESIGN: Randomised controlled study consisting of resistance training without (RT-G) or with (RTS-G) a soy protein based supplement and a control group with lifestyle education only (LE-G). SUBJECTS: Forty healthy middle aged men (50-65 years, BMI 25-29.9 kg/m2). MEASUREMENTS: Changes in body weight (BW) and waist circumference (WC) were measured and body composition (BC), fat mass (FM), lean body mass (LBM) were measured by skin fold anthropometry at baseline and after 12 weeks of intervention. In addition, changes in physical fitness, metabolic and hormonal parameters (lipids, glucose, fructosamines, insulin, insulin-like growth factor-1, Leptin, human growth hormone, dehydroepiandrosterone, testosterone, hs-CRP, Il-6) were evaluated. RESULTS: Thirty-five participants completed the 12 week study. No significant changes in BW were noted although RM and WC dropped and LBM increased after training, particularly in the RTS group (FM 22.6 ± 5.5 kg to 21.2 ± 4.7 kg; LBM 68.5 ± 7.2 kg to 70.1 ± 7.4; p < 0.01). Subjects in the RTS group experienced more pronounced improvements in the strength measurements than the RT group. After the training intervention there were significant changes in hormonal and metabolic parameters as well as in glycemic control, particularly in the RTS group. CONCLUSIONS: Our data suggest that resistance training, particularly in combination with a soy protein based supplement improves body composition and metabolic function in middle aged untrained and moderately overweight males.

The effect of calcium plus vitamin D on risk for invasive cancer: results of the Women's Health Initiative (WHI) calcium plus vitamin D randomized clinical trial.

In the Women's Health Initiative (WHI) trial of calcium plus vitamin D (CaD), we examined the treatment effect on incidence and mortality for all invasive cancers. Postmenopausal women (N = 36,282) were randomized to 1,000 mg of elemental calcium with 400 IU vitamin D3 or placebo. Cox models estimated risk of cancer incidence and mortality. After 7.0 yr, 1,306 invasive cancers were diagnosed in the supplement and 1,333 in the placebo group [hazard ratio (HR) = 0.98; CI = 0.90, 1.05, unweighted P = 0.54]. Mortality did not differ between supplement (315, annualized% = .26) and placebo [(347, 0.28%; P = 0.17; HR = 0.90 (0.77, 1.05)]. Significant treatment interactions on incident cancer were found for family history of cancer, personal total intake of vitamin D, smoking, and WHI dietary trial randomized group. Calcium/vitamin D supplementation did not reduce invasive cancer incidence or mortality. Supplementation lowered cancer risk in the WHI healthy diet trial arm and in women without a first-degree relative with cancer. The interactions are only suggestive given multiple testing considerations. The low vitamin D dose provided, limited adherence, and lack of serum 25(OH)D values should be considered when interpreting these findings.

Calcium plus vitamin D supplementation and the risk of nonmelanoma and melanoma skin cancer: post hoc analyses of the women's health initiative randomized controlled trial.

PURPOSE: In light of inverse relationships reported in observational studies of vitamin D intake and serum 25-hydroxyvitamin D levels with risk of nonmelanoma skin cancer (NMSC) and melanoma, we evaluated the effects of vitamin D combined with calcium supplementation on skin cancer in a randomized placebo-controlled trial. METHODS: Postmenopausal women age 50 to 79 years (N = 36,282) enrolled onto the Women's Health Initiative (WHI) calcium/vitamin D clinical trial were randomly assigned to receive 1,000 mg of elemental calcium plus 400 IU of vitamin D3 (CaD) daily or placebo for a mean follow-up period of 7.0 years. NMSC and melanoma skin cancers were ascertained by annual self-report; melanoma skin cancers underwent physician adjudication. RESULTS: Neither incident NMSC nor melanoma rates differed between treatment (hazard ratio [HR], 1.02; 95% CI, 0.95 to 1.07) and placebo groups (HR, 0.86; 95% CI, 0.64 to 1.16). In subgroup analyses, women with history of NMSC assigned to CaD had a reduced risk of melanoma versus those receiving placebo (HR, 0.43; 95% CI, 0.21 to 0.90; P(interaction) = .038), which was not observed in women without history of NMSC. CONCLUSION: Vitamin D supplementation at a relatively low dose plus calcium did not reduce the overall incidence of NMSC or melanoma. However, in women with history of NMSC, CaD supplementation reduced melanoma risk, suggesting a potential role for calcium and vitamin D supplements in this high-risk group. Results from this post hoc subgroup analysis should be interpreted with caution but warrant additional investigation.

Effects of tomato- and soy-rich diets on the IGF-I hormonal network: a crossover study of postmenopausal women at high risk for breast cancer.

To determine whether dietary modifications with tomato products and/or a soy supplement affected circulating levels of insulin-like growth factor (IGF)-1 and other markers of cell signaling in postmenopausal women at risk for developing breast cancer. Eligible and consented postmenopausal women at high risk for developing breast cancer were enrolled in a 26-week, two-arm (tomato and soy, 10 weeks each) longitudinal dietary intervention study in which each woman served as her own control. Changes in biochemical endpoints including IGF-I, IGF-binding protein (IGFBP)-3, estradiol, sex hormone-binding globulin (SHBG), C-peptide, and insulin were measured for each intervention arm. Carotenoid and isoflavone levels were measured to assess adherence. Significant increases in carotenoid and isoflavone levels during the tomato and soy study arms, respectively, suggested that women were adherent to both arms of the intervention. The tomato-rich diet had little effect on cell-signaling biomarkers previously associated with breast cancer risk. However, results of the soy intervention showed that concentrations of IGF-I and IGFBP-3 increased by 21.6 and 154.7 µmol/L, respectively (P = 0.001 for both) and SHBG decreased by 5.4 µmol/L (P < 0.001) after consumption of the soy protein supplement. Increased soy protein intake may lead to small, but significant, increases in IGF-I and IGFBP-3. Soy consumption also led to a significant decrease in SHBG, which has been hypothesized to promote, rather than prevent, cancer growth. Previous epidemiologic studies, however, have confirmed protective effect of soy on breast cancer. Additional investigation about the effect of soy on breast cancer risk and its mechanism of action is warranted.