Folic Acid Fortification Good or Bad?
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1 Folic Acid Fortification Good or Bad? Ellen Kampman Wageningen University University Medical Centre Nijmegen WCRF 2 nd Interna.onal Conference 12 September 2010
2 Should we introduce mandatory flour/bread fortification?
3 Cancer Epidemiol Biomark Prev 2006
4
5
6 Folate versus Folic acid Natural Synthetic
7 Countries (N = 53) with regulations for fortification of wheat flour with folic acid worldwide
8 Neural tube defect rates per 10,000 US population
9 Potential mechanisms, one-carbon metabolism Vitamin B2 DHFR hf R Adapted from Ulrich et al., Pharmacogenomics 2003
10
11 Dietary folate and colorectal cancer risk 25% risk in both cohort and case-control studies (Sanjoaquin, 2002). Cohorts per 100 µg/day: 0.84 ( ) Most studies: no association with total folate (including folic acid from supplements) WCRF/AICR report 2007
12 1,367 incident CRC cases matched to 2,325 controls for study center, age, and sex; ~9 % folate deficient RR 95%CI Matched + covariate adjusted adjusted for smoking, education, physical activity, and intake of alcohol and fiber. Eussen S et al, CEBP 2010
13 Folate and breast cancer 1 st author, year Cohort No. in cohort Breast cancer H vs L (RR, 95%CI) Stolzenberg- Solomon, 2006 Prostate, Lung, Colorectal and Overain Cancer Screening Trial Cohort 25,400 Post-meno 691 Total: 1.32 ( ) Supplements: 1.19 ( ) Dietary : 1.04 ( ) Maruti, 2009 VITAL cohort 35,023 Post-meno 743 Total: 0.78 ( ) Stevens, 2010 Cancer Prevention Study II Nutrition Cohort 70,656 Post-meno 3,696 Total: 1.03 ( ) Dietary: 1.12 ( )
14 Incidence rate of female cancer Canada, , age-standardised Public Health Agency of Canada, Sept
15 Fortification and disease prevention Deficiencies NTD Oral clefts?
16 Dosage, form, timing
17
18 All substances are poisonous, there is none which is not a poison; the right dose differentiates a poison from a remedy Paracelcus, 16 th century
19 What is (un)healthy?
20 Can we get too much?
21 Dietary supplement use in Europe
22 Intake of folic acid from foods, supplements and fortification in Europe - women
23 Plasma folate levels in EPIC
24 Median serum folate levels in the US
25 How much folate is in Canadian fortified products 10 years after mandated fortification? Ten years after folic acid fortification of the food supply, neither the Canadian Nutrient File nor label values accurately reflect actual amounts of folate in foods. Monitoring of fortified foods for their nutrient content is required.
26 Children most vulnerable for relatively high intakes?
27 Total folate and folic acid intakes of US children aged 1-13 y. > 95% at least Estimated Average Requirement 35% dietary supplement users; 28% with folic acid 53% of dietary supplement use exceeded the UL as compared to 5% of non-users
28 and form
29 Folate-mediated one-carbon metabolism Dietary folates Vitamin B2 Adapted from Ulrich et al., Pharmacogenomics 2003 DHFR hf R Folic acid from supplements or fortified foods
30 Circulating unmetabolised folic acid body s ability to convert it to natural folate is saturated at moderate intakes (400 µg/day) prevents timely diagnosis of vitamin B12 deficiency accelerates growth of pre-existing tumors? long-term effects unknown!
31 Folic acid in the circulation NHANES , cross-sectional, n=1121; 60 years and older ~ 40% unmetabolised folic acid (median: 1.2+/- 0.2 nmol/l) Associated with folic acid supplement use, higher folic acid intakes from food, higher serum folate concentration, but not with red blood folate
32 and timing.
33 Who are at increased cancer risk with fortification? Those with premalignant lesions Those with undetected malignancies Cancer patients during chemotherapeutic treatment (5FU, methotrexate)? Cancer survivors (high supplement use?)
34 Aspirine/Folic acid Prevention Trial Effect of 1mg/d folic acid on adenoma recurrence Relative Risk 95% CI All Adenomas Adenomas > 1 cm More than 3 adenomas 1 FU 1.04 ( ) 2 FU 1.13 ( ) 1 FU 1.32 ( ) 2 FU 1.67 ( ) 1 FU 1.20 ( ) 2 FU 2.32 ( ) Cole, Baron et al, JAMA 2007
35 NHS-HPFS folic acid prevention trial (1mg/day) Relative Risk 95% CI At least one Adenoma Large adenoma Advanced adenomas 1 FU 0.82 ( ) 2 FU 0.87 ( ) 1 FU 1.07 ( ) 2 FU 0.97 ( ) 1 FU 1.08 ( ) 2 FU 1.03 ( ) Wu K, Am J Clin Nutr 2009
36 UK cap trial (0.5 mg/day folic acid) Recurrent adenomas ~ 3 years of follow-up (%) RR (95%CI) Folic acid N=432 Placebo N=421 Any adenoma 26% 25% 1.07 ( ) Advanced adenomas 12% 12% 0.98 ( )
37 Two Norwegian randomised trials (ischemic heart disease; 0.8 mg/day) HRs and 95%CI N Cancer incidence Cancer mortality NORVIT 3, ( ) 1.29 ( ) WENBIT 3, ( ) 1.62 ( ) MTHFR677 genotype CC 3, ( ) 1.49 ( ) CT 2, ( ) 1.08 ( ) TT ( ) 4.57 ( ) Ebbing M et al, JAMA 2009
38 Potential mechanisms, one-carbon metabolism Vitamin B2 DHFR hf R Adapted from Ulrich et al., Pharmacogenomics 2003
39 DNA-methylation: gene silencing
40 Methylation equilibrium in good health
41 EFSA meeting Uppsala 2009 Main conclusions: Insufficient data for a full quantitative risk assessment of folic acid and cancer Intakes of folic acid should not exceed 1 mg/day (but UL is based on limited data..) Maximum levels need to be set for foods voluntary fortified with folic acid and for supplements For countries that decide to introduce mandatory fortification: monitoring systems are needed to assess folic acid intake, status, NTD and cancer incidence Additional research is necessary
42 Scientific Advisory Committee on Nutrition (SACN) October 2009 SACN upholds their previous recommendation (2007) for the introduction of mandatory fortification with folic acid. But, mandatory fortification should only be introduced in the UK if it is accompanied by: Action to restrict voluntary fortification of foods with folic acid; measures for careful monitoring of emerging evidence on any adverse effects of long-term exposure to intakes of folic acid above the GL/UL per day; guidance on supplement use for particular population groups. reports/ summary_of_report_to_cmo_on_folic_acid_and_colorect al_cancer_risk_-_october_2009.html
43 Should we introduce mandatory flour/bread fortification?
44 Natural folate enriched products
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