Sociodemographic and clinical characteristics associated with vitamin D status in newly diagnosed pediatric cancer patients.

Vitamin D deficiency and insufficiency are associated with serious sequelae in childhood cancer survivors. However, data on vitamin D deficiency in children with newly diagnosed cancer are scarce and the role of sociodemographic factors and vitamin D supplementation is largely unknown. We assessed vitamin D status and its socio-demographic and clinical correlates in 163 children with newly diagnosed cancer, using 25-hydroxy vitamin D (25(OH)D) concentrations and assessed longitudinal changes following vitamin D supplementation. Sixty-five percent of the patients with newly diagnosed cancer had low 25(OH)D concentrations. Fifty-two patients (32%) were vitamin D deficient (≤20 ng/mL 25(OH)D concentration), and 53(33%) were insufficient (21-29 ng/mL 25(OH)D concentration). Age over 10 (P = 0.019), Hispanic ethnicity (P = 0.002), and female sex (P = 0.008) were significantly associated with lower 25(OH)D concentration at diagnosis. Vitamin D supplementation resulted in significant increase in 25(OH)D concentrations (P < 0.001). However, following supplementation in the longitudinal analysis, this increase was less pronounced in Hispanic patients vs. non-Hispanic (P = 0.007), and in children with solid tumors vs. hematological malignancies (P = 0.003). Vitamin D deficiency and insufficiency are common in children with newly diagnosed cancer. Hispanic patients, females and older children were at higher risk for vitamin D deficiency and insufficiency. Although supplementation appeared to increase 25(OH)D concentrations over time, this increase was not as pronounced in certain subsets of patients. Prospective trials of the effects of vitamin D supplementation on bone health in children with newly diagnosed cancer are warranted, particularly in Hispanics and patients with solid tumors.

Improvement of nutritional quality of local dishes and their acceptance by children of different ages / Melhoria de pratos típicos: qualidade nutricional e sua aceitação por crianças de várias idades

ABSTRACT Objective Food insecurity and child malnutrition are central topics in many food programs around the world; however, these indices do not diminish. The creation of strategies is necessary to increase the effectiveness of nutritional improvement programs. The objective of this research was to improve the nutritional quality of three local dishes included in the regular diet of the population by adding amaranth and to evaluate their acceptance by children from three communities in Tochimilco, Puebla, Mexico. Methods The study was carried out in three communities of "Tochimilco", Puebla, Mexico, in order to evaluate three local dishes: banana smoothie, beans and corn tortillas, which were chosen by mothers of the region in participative workshops on preparation of local dishes enriched with amaranth. Two sensory tests were applied: paired-comparison and hedonic scale to 208 and 210 children of preschool and scholar age, respectively. Results It was found that consumers showed similar preference for banana smoothie and beans enriched with amaranth compared to non-enriched dishes; while the amaranth enriched tortilla gained more preference in the different statistical tests and it was the dish with higher content of amino acids. Sensory attributes were similarly assessed and there were no significant differences among rural and urban communities and school year. Conclusion Children easily accept the addition of amaranth to the dishes they are accustomed to, as it does not change their food culture. It is possible to improve child nutrition by designing healthier dishes and incorporating them into the daily cooking of those who prepare the food.

RESUMO Objetivo A insegurança alimentar e a desnutrição infantil são temas centrais de muitos programas alimentares ao redor do mundo; no entanto, esses índices não diminuem. É preciso criar estratégias para aumentar a eficácia dos programas de desenvolvimento nutricional. A presente pesquisa teve como objetivo melhorar a qualidade nutricional de três pratos típicos da dieta normal da população local, adicionando amaranto às comidas típicas e avaliando a aceitação dele por crianças de três comunidades em Tochimilco, Puebla, México. Métodos O estudo foi realizado nas três comunidades para avaliar os três pratos típicos desta mesma região: vitamina de banana, feijão e as tortilhas de milho. Estas comidas foram escolhidas por mães da região em oficinas participativas de preparação de pratos locais enriquecidos com amaranto. Dois testes sensoriais foram aplicados: comparação pareada e escala hedônica para 208 e 210 crianças em idade pré-escolar e escolar, respectivamente. Resultados Verificou-se que os consumidores mostraram uma preferência semelhante pela vitamina de banana e feijão enriquecido com amaranto do que os mesmos não enriquecidos; enquanto a tortilha de milho enriquecida com amaranto ganhou mais preferência nos diferentes testes estatísticos e foi o prato com maior teor de aminoácidos. Os atributos sensoriais foram avaliados da mesma forma e não houve diferenças significativas entre as comunidades rurais e urbanas e as notas escolares. Conclusão As crianças aceitam facilmente a incorporação de amaranto nos pratos típicos da dieta delas, pois não repre-sentou nenhuma alteração da sua cultura alimentar. É possível melhorar a nutrição infantil, criando pratos mais saudáveis e incorporando-os na culinária cotidiana daqueles que preparam a comida.

Technology-assisted stroke rehabilitation in Mexico: a pilot randomized trial comparing traditional therapy to circuit training in a Robot/technology-assisted therapy gym.

BACKGROUND: Stroke rehabilitation in low- and middle-income countries, such as Mexico, is often hampered by lack of clinical resources and funding. To provide a cost-effective solution for comprehensive post-stroke rehabilitation that can alleviate the need for one-on-one physical or occupational therapy, in lower and upper extremities, we proposed and implemented a technology-assisted rehabilitation gymnasium in Chihuahua, Mexico. The Gymnasium for Robotic Rehabilitation (Robot Gym) consisted of low- and high-tech systems for upper and lower limb rehabilitation. Our hypothesis is that the Robot Gym can provide a cost- and labor-efficient alternative for post-stroke rehabilitation, while being more or as effective as traditional physical and occupational therapy approaches. METHODS: A typical group of stroke patients was randomly allocated to an intervention (n = 10) or a control group (n = 10). The intervention group received rehabilitation using the devices in the Robot Gym, whereas the control group (n = 10) received time-matched standard care. All of the study subjects were subjected to 24 two-hour therapy sessions over a period of 6 to 8 weeks. Several clinical assessments tests for upper and lower extremities were used to evaluate motor function pre- and post-intervention. A cost analysis was done to compare the cost effectiveness for both therapies. RESULTS: No significant differences were observed when comparing the results of the pre-intervention Mini-mental, Brunnstrom Test, and Geriatric Depression Scale Test, showing that both groups were functionally similar prior to the intervention. Although, both training groups were functionally equivalent, they had a significant age difference. The results of all of the upper extremity tests showed an improvement in function in both groups with no statistically significant differences between the groups. The Fugl-Meyer and the 10 Meters Walk lower extremity tests showed greater improvement in the intervention group compared to the control group. On the Time Up and Go Test, no statistically significant differences were observed pre- and post-intervention when comparing the control and the intervention groups. For the 6 Minute Walk Test, both groups presented a statistically significant difference pre- and post-intervention, showing progress in their performance. The robot gym therapy was more cost-effective than the traditional one-to-one therapy used during this study in that it enabled therapist to train up to 1.5 to 6 times more patients for the approximately same cost in the long term. CONCLUSIONS: The results of this study showed that the patients that received therapy using the Robot Gym had enhanced functionality in the upper extremity tests similar to patients in the control group. In the lower extremity tests, the intervention patients showed more improvement than those subjected to traditional therapy. These results support that the Robot Gym can be as effective as traditional therapy for stroke patients, presenting a more cost- and labor-efficient option for countries with scarce clinical resources and funding. TRIAL REGISTRATION: ISRCTN98578807 .

Selenium Supplementation for Prevention of Colorectal Adenomas and Risk of Associated Type 2 Diabetes.

BACKGROUND: Selenium supplementation may help to prevent colorectal cancer; as precursors of colorectal cancer, colorectal adenomas are a surrogate for colorectal cancer. Selenium supplementation may increase risk of type 2 diabetes (T2D). METHODS: The Selenium and Celecoxib (Sel/Cel) Trial was a randomized, placebo controlled trial of selenium 200 µg daily as selenized yeast and celecoxib 400 mg once daily, alone or together, for colorectal adenoma prevention. Men and women between age 40 and 80 years were eligible following colonoscopic removal of colorectal adenomas. The primary outcome was adenoma development. Celecoxib was suspended because of cardiovascular toxicity in other trials, but accrual continued to selenium and placebo. A total of 1621 participants were randomly assigned to selenium or placebo, of whom 1374 (84.8%) were available for analysis. All statistical tests were two-sided. RESULTS: In the respective placebo and selenium arms of 689 and 685 participants, adenoma detection after medians of 33.6 (range = 0.0-85.1 months) and 33.0 months (range = 0.0-82.6 months) were 42.8% and 44.1% (relative risk [RR] = 1.03, 95% confidence interval [CI] = 0.91 to 1.16, P = .68). In participants with baseline advanced adenomas, adenoma recurrence was reduced by 18% with selenium (RR = 0.82, 95% CI = 0.71 to 0.96, P = .01). In participants receiving selenium, the hazard ratio for new-onset T2D was 1.25 (95% CI = 0.74 to 2.11, P = .41), with a statistically significantly increased risk of selenium-associated T2D among older participants (RR = 2.21; 95% CI = 1.04 to 4.67, P = .03). CONCLUSIONS: Overall, selenium did not prevent colorectal adenomas and showed only modest benefit in patients with baseline advanced adenomas. With limited benefit and similar increases in T2D to other trials, selenium is not recommended for preventing colorectal adenomas in selenium-replete individuals.

Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention.

COX inhibitors reduce colorectal adenoma recurrence by up to 45% and selenium supplementation may prevent colorectal cancer. Following colonoscopic adenoma resection, 1,600 men and women, ages 40 to 80 years, were randomized to celecoxib (400 mg daily), a selective COX-2 inhibitor, and/or selenium (200 µg daily as selenized yeast), or double placebo. The trial was initiated in November 2001. The primary trial endpoint is adenoma recurrence in each intervention group compared with placebo, as determined by surveillance colonoscopy conducted three to five years after baseline. Randomization was stratified by use of low-dose aspirin (81 mg) and clinic site. Following reports of cardiovascular toxicity associated with COX-2 inhibitors, the celecoxib arm was discontinued in December 2004 when 824 participants had been randomized. Accrual continued with randomization to selenium alone or placebo. Randomization of the originally planned cohort (n = 1,621) was completed in November 2008. A further 200 patients with one or more advanced adenomas (denoting increased risk for colorectal cancer) were accrued to enhance statistical power for determining intervention efficacy in this higher-risk subgroup. Accrual of the total cohort (n = 1,824) was completed in January 2011. Baseline cohort characteristics include: mean age 62.9 years; 65% male; body mass index (BMI) 29.1 ± 5.1; 47% taking low-dose aspirin while on trial; 20% with three or more adenomas; and 38% with advanced adenomas. Intervention effects on adenoma recurrence will be determined, and their modification by genetic background and baseline selenium level. The effect of selenium supplementation on risk for type II diabetes will also be reported.

Dietary supplements and cancer prevention: balancing potential benefits against proven harms.

Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk.

Vitamin D: marker or mechanism of action?

The field of vitamin D and cancer research has been moving forward quickly. However, some challenges remain regarding the interpretation and integration of data collected from epidemiological investigations and laboratory experiments. These include consideration of vitamin D biology, a better understanding of characteristics that affect concentrations of the biomarker of vitamin D status, 25(OH)D, and elucidation of variation in response to vitamin D supplementation. To further the field of vitamin D and cancer prevention, future studies will need to bridge the gap between the epidemiology and molecular biology of vitamin D activity in carcinogenesis.

A candidate gene study of folate-associated one carbon metabolism genes and colorectal cancer risk.

BACKGROUND: Folate-associated one-carbon metabolism (FOCM) may play an important role in colorectal carcinogenesis. Variation in FOCM genes may explain some of the underlying risk of colorectal cancer. METHODS: This study utilized data from 1,805 population-based colorectal cancer cases and 2,878 matched sibling controls from the Colon Cancer Family Registry. We used a comprehensive haplotype tagging single nucleotide polymorphism (tagSNP) approach to select 395 tagSNPs in 15 genes involved in folate and vitamin B(12) metabolism. Genotyping was done using the Illumina GoldenGate or Sequenom platforms. Risk factor and dietary data were collected using self-completed questionnaires. Microsatellite instability (MSI) status was determined using standard techniques, and tumor subsite was obtained from pathology reports. The association between SNPs and colorectal cancer was assessed using conditional logistic regression with sibships as the matching factor and assuming a log additive or codominant model. RESULTS: In the log additive model, two linked (r(2) = 0.99) tagSNPs in the DHFR gene (rs1677693 and rs1643659) were associated with a significant decrease in colorectal cancer risk after correction for multiple testing (odds ratio, 0.87; 95% confidence interval, 0.71-0.94; P = 0.029; and odds ratio, 0.87; 95% confidence interval, 0.71-0.95; P = 0.034 for rs1677693 and rs1643659, respectively). These two linked (r(2) = 0.99) tagSNPs and one tagSNP in the MTR gene (rs4659744) were significantly associated with reduced colorectal cancer risk only among individuals not using multivitamin supplements. CONCLUSIONS: Overall, we found only moderate evidence that genetic variation in 15 folate pathway genes may affect colorectal cancer risk except in non-multivitamin users. IMPACT: This study suggests that multivitamin supplement use may modify the association between folate pathway genes and colorectal cancer risk in a post-folic-acid-supplemented population.

Genetic variability in the MTHFR gene and colorectal cancer risk using the colorectal cancer family registry.

BACKGROUND: The MTHFR C677T TT genotype is associated with a 15% to 18% reduction in colorectal cancer risk, but it is not clear if other variants of the gene are associated with colorectal cancer risk. METHODS: We used a tagSNP approach to comprehensively evaluate associations between variation in the MTHFR gene and colorectal cancer risk using a large family-based case-control study of 1,750 population-based and 245 clinic-based families from the Colon Cancer Family Registry. We assessed 22 TagSNPs, selected based on pairwise r(2) >95%, using the Haploview Tagger and genotyped the TagSNPs on the Illumina GoldenGate or Sequenom platforms. The association between single nucleotide polymorphisms and colorectal cancer was assessed using log-additive, codominant, and recessive models. RESULTS: From studying the population-based families, the C677T (rs1801133) and A1298C (rs1801131) polymorphisms were associated with a decreased colorectal cancer risk overall [odds ratio (OR), 0.81; 95% confidence interval (95% CI), 0.63-1.04; and OR, 0.82; 95% CI, 0.64-1.07, respectively]. The 677 TT genotype was associated with a decreased risk of microsatellite-stable/microsatellite-low tumors (OR, 0.69; 95% CI, 0.49-0.97) and an increased risk of microsatellite-high tumors (OR, 2.22; 95% CI, 0.91-5.43; P(interaction) = 0.01), as well as an increased risk of proximal cancers and a decreased risk of distal and rectal cancers (P(interaction) = 0.02). No other single nucleotide polymorphism was associated with risk overall or within subgroups. CONCLUSION: The 677 TT and 1298 CC genotypes may each be associated with a decrease in colorectal cancer risk. We observed little evidence of additional genetic variability in the MTHFR gene relevant to colorectal cancer risk.

Diet and cancer prevention: the roles of observation and experimentation.

Observational epidemiology and experimentation by randomized controlled trials (RCTs) have been used to evaluate dietary factors in cancer prevention; however, consistency in findings has been elusive. In several circles, RCTs are viewed as more credible than observational studies. As the testing of dietary epidemiological findings in RCTs has been more common for colorectal cancer than for other cancers, we use experience with this malignancy to critically appraise the reasons for discrepancies between results of observational and experimental studies.

Dietary factors and biomarkers involved in the methylenetetrahydrofolate reductase genotype-colorectal adenoma pathway.

BACKGROUND & AIMS: Methylenetetrahydrofolate reductase (MTHFR) is involved in intracellular folate homeostasis and metabolism. We assessed 2 polymorphisms in the MTHFR gene (C677T and A1298C) in relation to colorectal adenoma recurrence and conducted analyses to investigate their joint effects with plasma and dietary markers of folate status. METHODS: We prospectively analyzed data from 1598 individuals genotyped for the C677T polymorphism and 1583 with data on A1298C. RESULTS: Among nonusers of multivitamin supplements, compared with wild-type carriage, higher odds of recurrence were observed for those with the 677 TT variant (odds ratio [OR], 1.66; 95% confidence interval [CI], 1.04-2.63) and a nonsignificant increase was observed among those with the 1298 CC variant (OR, 1.50; 95% CI, 0.93-2.40). Diplotype analyses among nonusers of multivitamins showed that individuals who carry the MTHFR 677TT_1298AA or 677CC_1298CC combination were significantly more likely to have a recurrence compared with those with the double wild-type (OR, 2.05 for TT_AA and 1.85 for CC_CC). Higher odds of recurrence were observed among participants with low folate intake or plasma folate and the 677 TT or 1298 CC variants compared with those with lower levels and the wild-type or heterozygous genotypes. Stronger associations were shown for the combination of high homocysteine and the 677 TT variant (OR, 2.29; 95% CI, 1.00-5.26) but not the 1298 CC variant (OR, 1.09; 95% CI, 0.39-3.01). CONCLUSIONS: We propose that the effect of the MTHFR genotypes on increasing risk of adenoma recurrence in the presence of a low folate status is through their increase in homocysteine concentrations, which in turn could result in DNA hypomethylation via pathways involving S-adenosylhomocysteine.

Folate fortification, plasma folate, homocysteine and colorectal adenoma recurrence.

In 1996, the US Food and Drug Administration mandated the fortification of grain products with folic acid, a nutrient that has been associated with lower risk of colorectal neoplasia. We assessed the relation of plasma folate and homocysteine and colorectal adenoma recurrence separately in 2 studies: the first involved an intervention of a cereal supplement that contained folic acid, wheat bran fiber (WBF), and the second was conducted primarily during postfortification of the food supply using ursodeoxycholic acid (UDCA). Analyses were stratified for multivitamin use. Results show that plasma folate and homocysteine concentrations were associated with adenoma recurrence among nonusers of multivitamins only. Among nonmultivitamin users, the odds ratio [OR] (95% confidence interval [CI]) for those in the highest versus the lowest folate quartile was 0.65 (0.40-1.06) for the WBF study and 0.56 (0.31-1.02) for the UDCA; likewise, individuals in the highest versus the lowest quartile of homocysteine had higher odds of adenoma recurrence, in both the WBF (OR = 2.25; 95% CI = 1.38-3.66) and UDCA (OR = 1.93; 95% CI = 1.07-3.49) populations. Analyses comparing multivitamin users to different plasma folate concentrations among nonusers show that odds of recurrence for supplement users was lower only when compared to nonusers who had lower concentrations. Our results show that higher plasma folate or lower homocysteine levels are associated with lower odds of recurrence among nonusers of multivitamins in both studies. Our finding, suggesting that multivitamins or supplemental folate only benefit individuals with lower plasma folate concentrations, should be taken into consideration when designing and interpreting results of intervention studies.

Wheat bran fiber supplementation and bone loss among older people.

OBJECTIVE: The purpose of this study was to investigate the effect of wheat bran fiber (WBF) supplementation on bone loss in older people. METHODS: Two hundred thirty-seven men and women ages 40 to 80 y were included in this study. They constituted a subgroup of participants from a 3-y WBF intervention trial for preventing recurrence of colorectal adenomas. These participants were randomized into a high (13.5 g/d) or a low (2 g/d) WBF supplementation group. Bone mineral density at the forearm was measured by single photon absorptiometry at baseline and yearly during the intervention to monitor possible toxic effects of fiber supplementation on bone metabolism. RESULTS: Baseline characteristics of this subgroup of participants from the WBF trial were similar between the high and low supplementation groups. The annual amounts of bone loss at the radial third site were -0.017 +/- 0.018 g/cm2 and -0.013 +/- 0.021 g/cm2, respectively, for the low and high WBF groups; and the annual bone losses at the ultra-distal site were was -0.005 +/- 0.020 g/cm2 and -0.006 +/- 0.027 g/cm2, respectively, for the low and high WBF groups. After controlling for confounding factors, we found no significant differences in bone loss between groups (P > 0.05). CONCLUSION: WBF supplementation at the level given in this study may not have a significant effect on bone loss among older people.

Dietary change in an intervention trial of wheat bran fiber and colorectal adenoma recurrence.

PURPOSE: The objectives of this study were to determine whether participants in the Wheat Bran Fiber (WBF) trial exhibited changes in diet over time, and whether these changes were differential by assigned treatment group. METHODS: The WBF trial was a randomized trial with participants assigned to one of two groups: a low-fiber (2.0 g/d) or high-fiber (13.5 g/d) wheat bran fiber cereal supplement. A total of 685 participants from both treatment groups completed the Arizona Food Frequency Questionnaire (AFFQ) at baseline, year one, and year three of the trial. Means were calculated for nutrient intake, change in nutrient intake, number of food group servings, and change in number of food group servings. RESULTS: For both treatment groups combined, significant increases were observed for most micronutrients and vitamins at years one and three, while fat intake significantly decreased. Participants from both groups significantly increased their consumption of cereals, breads, and crackers, but decreased the number of servings from the meat, poultry, and egg group, the fats group, and the salty snacks group. The only differential changes in intake between the treatment groups were for sugar and iron, which increased to a lesser extent among those assigned to the high-fiber treatment as compared with the low-fiber group. CONCLUSIONS: Although differential dietary intake was not appreciable in the WBF trial, participants exhibited longitudinal changes. Future intervention studies should carefully monitor dietary changes during the trial with multiple dietary assessment tools to assess potential secular and treatment-related diet changes.

Folate and colorectal neoplasia: relation between plasma and dietary markers of folate and adenoma recurrence.

BACKGROUND: The results of epidemiologic studies indicate that higher intakes or blood concentrations of folate are associated with a lower risk of colorectal neoplasia; however, only one study assessed the role of homocysteine. OBJECTIVE: We assessed the relation between biochemical and dietary markers of folate status and colorectal adenoma recurrence. DESIGN: Analyses were conducted in 1014 men and women aged 40-80 y who had undergone removal of all colorectal polyps. Diet and supplement use were ascertained through a food-frequency questionnaire administered at study entry. Blood collected at baseline was used to measure plasma folate and homocysteine concentrations. Unconditional logistic regression was used to assess the odds of recurrence associated with the intakes of folate, methionine, and vitamins B-6 and B-12 and with plasma folate and homocysteine. RESULTS: Relative to subjects in the highest quartile of plasma homocysteine, those in the lowest quartile had an odds ratio (OR) of adenoma recurrence of 0.69 (95% CI: 0.47, 1.02; P for trend = 0.02) after adjustment for confounding factors. Lower odds of recurrence were shown for higher plasma folate (OR: 0.66; 95% CI: 0.46, 0.97) and higher total intakes (dietary plus supplemental) of folate (OR: 0.61; 0.42, 0.89) and vitamin B-6 (OR: 0.65; 0.45, 0.94). Slightly weaker and nonsignificant associations were shown for dietary folate, methionine, and total vitamin B-12. CONCLUSIONS: A lower recurrence of colorectal adenomas was shown in subjects with higher intakes and plasma concentrations of folate. Additional markers involved in folate metabolism, including lower homocysteine and higher vitamin B-6 intake, were also associated with lower odds of recurrence.

Baseline dietary fiber intake and colorectal adenoma recurrence in the wheat bran fiber randomized trial.

BACKGROUND: The Wheat Bran Fiber (WBF) trial was a double-blind, high-fiber versus low-fiber phase III intervention trial in which participants were randomly assigned to receive a cereal fiber supplement of either 2.0 g/day or 13.5 g/day to assess whether a high-fiber supplement could decrease risk of recurrent colorectal adenomas. Although no effect of the supplement on polyp recurrence was observed, participants consumed a baseline average of 17.5 grams of fiber per day, which may have been sufficient to protect against adenoma recurrence. Therefore, we examined whether baseline fiber intake affected colorectal adenoma recurrence or modified the effect of treatment group in the WBF trial participants. METHODS: Quartiles of baseline fiber intake were calculated on the basis of the distribution in the study population. Odds ratios (ORs) for adenoma recurrence were calculated using the lowest quartile of fiber intake as the reference. The effect of fiber from specific food sources on adenoma recurrence was also assessed. All statistical tests were two-sided. RESULTS: Adjusted ORs (95% confidence intervals) for adenoma recurrence were 0.79 (0.56 to 1.12), 0.76 (0.54 to 1.08), and 0.83 (0.57 to 1.19) for the second, third, and fourth quartiles, respectively. Fiber from the three primary food sources (fruits; breads, cereals and crackers; and vegetables) had no appreciable effect on adenoma recurrence. Baseline fiber intake also had little effect on adenoma recurrence when the population was stratified by treatment group. In addition, there was no interaction between treatment group and quartile of baseline fiber intake. CONCLUSIONS: No association was found between amount of fiber consumed at baseline and adenoma recurrence in the WBF trial participants. The baseline fiber intake, whether considered as a whole or from specific sources, did not modify the effect of treatment group.

Intake of supplemental and total fiber and risk of colorectal adenoma recurrence in the wheat bran fiber trial.

The Wheat Bran Fiber (WBF) trial was a double-blind Phase III clinical trial in which participants were randomized to a cereal fiber supplement of either 13.5 or 2.0 g/day. No protective effect for adenoma recurrence was observed for those randomized to the high-fiber group as compared with those in the low-fiber group. However, the high-fiber group had significantly lower adherence to the supplement as assessed by cereal box counts. The aim of this study was to determine whether reported supplemental and total fiber intake affected colorectal adenoma recurrence in the WBF trial population, regardless of treatment group assignment. A total of 1208 participants who completed the WBF trial had a colonoscopy before the date of the last cereal box count and/or at least one colonoscopy within 90 days after it and, thus, were eligible for the current analyses. Statistical analyses were done using multivariate logistic regression models that included potentially confounding variables. Compared with individuals consuming less than 1.8 g/day of supplemental fiber, the adjusted odds ratio (95% confidence interval) for adenoma recurrence for those consuming greater than 11.0 g/day was 0.94 (0.66-1.33). The odds ratio (95% confidence interval) for participants whose total fiber intake was greater than 30.3 g/day was 0.98 (0.68-1.42) compared with those whose intake was less than 17.9 g/day. The results of this study show that neither fiber intake from a wheat bran supplement nor total fiber intake affects the recurrence of colorectal adenomas, thus lending further evidence to the body of literature indicating that consumption of a high-fiber diet, especially one rich in cereal fiber, does not reduce the risk of colorectal adenoma recurrence.