The Men's Eating and Living (MEAL) Study: A Cancer and Leukemia Group B Pilot Trial of Dietary Intervention for the Treatment of Prostate Cancer

The Ohio State University, Columbus, Ohio, United States
Urology (Impact Factor: 2.19). 03/2008; 72(3):633-7. DOI: 10.1016/j.urology.2007.11.050
Source: PubMed


To evaluate the feasibility of implementing a diet-based intervention in men with prostate cancer.
Seventy-four men aged 50 to 80 years with biopsy-proven adenocarcinoma of the prostate were randomized to receive either telephone-based dietary counseling or standardized, written nutritional information. Telephone dietary counseling targets included increased intakes of vegetables (particularly cruciferous vegetables and tomato products), whole grains, and beans/legumes. Dietary intakes and plasma carotenoid levels were assessed at baseline and at 6 months' follow-up.
In the intervention arm, mean daily intakes of total vegetables, crucifers, tomato products, and beans/legumes increased by 76%, 143%, 292%, and 95%, respectively, whereas fat intake decreased by 12% (P = 0.02). In the control arm, there were no significant changes in mean intakes of total vegetables, tomato products, crucifers, beans/legumes, or fat. Similarly, in the intervention arm, mean plasma levels of alpha-carotene, beta-carotene, lutein, lycopene, and total carotenoids increased by 33%, 36%, 19%, 30%, and 26%, respectively (P <0.05). In the control arm, there were no significant changes in plasma levels of alpha- or beta-carotene, lutein, lycopene, or total carotenoids.
Telephone-based dietary counseling increases vegetable intake, decreases fat intake, and significantly increases plasma levels of potentially anticarcinogenic carotenoids in men with prostate cancer. These data support the feasibility of implementing clinical trials of dietary intervention in men with prostate cancer.

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    • "Study design The MEAL Study is a randomized, phase III clinical trial. The intervention is a validated, telephone-based counseling program [24] [25]. We are randomizing 464 patients on active surveillance to either the telephone-based counseling intervention or the control condition in which patients receive printed materials from the Prostate Cancer Foundation that recommend consumption of a healthy diet (Fig. 1). "
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    ABSTRACT: Background: Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer. Study design: MEAL is a randomized, phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance. We are randomizing 464 patients to either a validated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline. The intervention will continue for two years. The primary outcome variable is clinical progression defined by serum prostate-specific antigen (PSA) and pathological findings on follow-up prostate biopsy. Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer, prostate-cancer related patient anxiety and health-related quality of life. Conclusion: The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance.
    Full-text · Article · May 2014 · Contemporary Clinical Trials
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    • "In addition, this study provided further evidence that active surveillance can offer a unique window of opportunity for investigating potential chemopreventive agents [37], [38]. Other trials including the Men's Eating and Living Study (MEAL) also provide important data on the feasibility of implementing clinical trials of dietary intervention in men with low risk prostate cancer [4], [15], [39], [40], [41]. "
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    ABSTRACT: Studies suggest that micronutrients may modify the risk or delay progression of prostate cancer; however, the molecular mechanisms involved are poorly understood. We examined the effects of lycopene and fish oil on prostate gene expression in a double-blind placebo-controlled randomized clinical trial. Eighty-four men with low risk prostate cancer were stratified based on self-reported dietary consumption of fish and tomatoes and then randomly assigned to a 3-month intervention of lycopene (n = 29) or fish oil (n = 27) supplementation or placebo (n = 28). Gene expression in morphologically normal prostate tissue was studied at baseline and at 3 months via cDNA microarray analysis. Differential gene expression and pathway analyses were performed to identify genes and pathways modulated by these micronutrients. Global gene expression analysis revealed no significant individual genes that were associated with high intake of fish or tomato at baseline or after 3 months of supplementation with lycopene or fish oil. However, exploratory pathway analyses of rank-ordered genes (based on p-values not corrected for multiple comparisons) revealed the modulation of androgen and estrogen metabolism in men who routinely consumed more fish (p = 0.029) and tomato (p = 0.008) compared to men who ate less. In addition, modulation of arachidonic acid metabolism (p = 0.01) was observed after 3 months of fish oil supplementation compared with the placebo group; and modulation of nuclear factor (erythroid derived-2) factor 2 or Nrf2-mediated oxidative stress response for either supplement versus placebo (fish oil: p = 0.01, lycopene: p = 0.001). We did not detect significant individual genes associated with dietary intake and supplementation of lycopene and fish oil. However, exploratory analyses revealed candidate in vivo pathways that may be modulated by these micronutrients. NCT00402285.
    Full-text · Article · Sep 2011 · PLoS ONE
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    • "These dietary interventions were instrumental in conducting much needed clinical trials and achieved modest short-term diet changes but were comprehensive and labor-intensive and would be difficult to apply to larger patient populations. In addition, many were adapted from programs originally developed for women's diet intervention studies and were not gender savvy in their design and delivery (Demark-Wahnefried et al., 2007; Link et al., 2004; Parsons et al., 2008). "
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    ABSTRACT: Although healthy eating might enhance long-term survival, few men with prostate cancer make diet changes to advance their well-being. Men's typically poor diets and uninterest in self-health may impede nutrition interventions and diet change. Food choice behavior is complex involving many determinants, including gender, which can shape men's health practices, diets, and prostate cancer experiences. Developing men-centered prostate cancer nutrition interventions to engage men (and where appropriate their partners) in promoting healthy diets can afford health benefits. This article presents an overview and synthesis of current knowledge about men's food practices and provides an analysis of diet and diet change behaviors for men with prostate cancer. Masculinity and gender relations theory are discussed in the context of men's food practices, and suggestions for future applications to nutrition and prostate cancer research and diet interventions are made.
    Full-text · Article · Mar 2011 · American journal of men's health
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