A Randomized Trial of Lycopene Supplementation in Tobago Men with High Prostate Cancer Risk

Abstract

This unblinded, randomized, Phase I clinical trial was conducted to determine whether lycopene supplementation lowered serum prostate specific antigen (PSA), surrogate endpoint for prostate cancer initiation or progression, in men with elevated prostate cancer risk. Afro-Caribbean men (n=81) with high-grade prostatic intraepithelial neoplasia, atypical foci or repeated non-cancerous biopsies, ascertained in a population-based screening program, were randomized to four months intervention with 30 mg/day lycopene (Lyc-O-Mato) plus a multivitamin, or to multivitamin, only. Serum PSA and lycopene were compared at randomization, 1, and 4 mo using two-sided chi2 and t-tests for independent samples. Treatment groups were similar at baseline. Serum lycopene levels approximately doubled in the lycopene intervention group. Serum PSA declined during the first month of treatment, but returned to randomization level by month 4. The PSA response was nearly identical in both treatment groups. No adverse effects attributed to lycopene supplementation were documented. We conclude that the PSA lowering response to antioxidant supplementation observed in previous 3-wk studies in men awaiting prostatectomy may have been a transient response, perhaps not specific to lycopene. Lowering of serum PSA may not be an appropriate endpoint for the long-term studies needed to evaluate lycopene supplementation for reducing prostate cancer initiation or progression.

Mercury modulates interplay between IL-1β, TNF-α, and gap junctional intercellular communication in keratinocytes: mitigation by lycopene

“…More importantly, the level of lycopene here is still well below that seen in adults taking a lycopenebearing antioxidant supplement as described in Bunker et al, (2007). Taking into account that significant differences in lycopene uptake among organs, tissues and cell types (Khachik et al, 2002;Liu et al, 2006) can occur, the concentration used in this study is compatible with the physiological levels, and is consistent with the lycopene intake that could be obtained from a standard (albeit Mediterranean) diet.…”

“…It has to be remarked that the level of lycopene used in this study (30.4 ng/ml) is near or below those commonly seen in the serum of adult humans (i.e., 28-31, 54-86, or 170-190 ng/ml), depending on population being studied (Anderson et al, 2006;Riccioni et al, 2007;Bunker et al, 2007). More importantly, the level of lycopene here is still well below that seen in adults taking a lycopenebearing antioxidant supplement as described in Bunker et al, (2007).…”

Nutraceuticals and Nutraceutical Supplementation Criteria in Cancer: A Literature Survey

“…Around the globe federal and government efforts have accumulated on consensus for statutory policy to use nutraceuticals on their daily requirements, supplementation, combinations and dosage to prevent or manage the cancer [79][80][81][82][83]. Randomized and double blind control trials indicated the increased importance of vitamins, herbs and fresh vegetables as likely protective supplements [84][85][86][87][88][89][90], tomato (lycopene) in prostate cancer prevention [91][92][93], nutritional intervention in different cancers of different body organs in the body [94][95][96][97][98][99][100]. New concept of Mediterranean diet was introduced to reduce the risk of cancer along with cardioprotection [101][102][103][104].…”

Investigation of the Potential Anticancer Effects of Lycopene in Tissue Engineered In vitro and In vivo Models

“…As the bond between lycopene and macromolecules within the food-matrix is comparatively strong, its bioavailability from dietary sources is rather remote, but can be enhanced by processing the food, like cooking or chopping, in order to separate complexes between lycopene and protein [76,100]. The food matrix, to which lycopene is tightly attached, is thought to contribute to the maintenance of a stable all-trans isomer, thereby preventing the molecule to isomerize to the cis-conformation.…”