Do Dietary Supplements have a place in Healthy Asian Diets??? Johanna Dwyer, D.Sc,RD Tufts University 1
Thank you for inviting me! 2
Common Ground: All countries need to improve diets low in micronutrients 3
Are dietary supplements needed for healthy dietsand nutritional well being in Asia??? 4
Do dietary supplements have a role in healthy Asian diets? Strategies to achieve healthy diets US experience mixed Is experience importable to Asia? Future 5
US mixed success in using supplements to prevent deficiency Combination of strategies most help in USA Supplements not always best option Success depended on time, place and population targeted 6
Strategies to obtain healthy diets 7
How do experts say to obtain a healthy diet??? First, follow food-based dietary guidelines Food first Dietary diversity Focus on nutrient dense food sources Meet but avoid exceeding energy needs If necessary, then consider supplements
Best strategy for achieving healthy diets and preventing vitamin deficiency depends on the problem to be addressed Food based dietary guidelines/diet diversity Poverty alleviation and distributive justice Fortification/Enrichment Dietary supplements US experience may be helpful 9
Food Based Dietary Guidelines 10
Best strategy to achieve healthy diets depends on the problem to be addressed Diversify Diet/ Food Based Dietary Guidelines Enrich/ Fortify Use Dietary supplements 11
Possible to define healthy diets, but not possible to define healthy foods! Problem: Not possible to define healthy foods Foodsonly become healthy or unhealthy in particular contexts for particular people Solution: Present and provide foods that are likely to lead to healthy or unhealthy diets Healthy and Unhealthy foods: http://www.hc-sc.gc.ca/fnan/nutrition/pol/exsum (health Canada)
Micronutrients needing special attention Only found in few foods Vitamin D, Occur naturally only at very low levels or are poorly bioavailable --Iron, Folate, Vitamin A Removed in processing Thiamine, Mg, Vitamin E, others 13
Supplement Use Common in USA (NHANES 1999-2002) Sources: Am J Epidemiol 2004;160:339-349 and APAM 2007;161:978-985 14
US Experience with Food Based Dietary Guidelines : Helpful but not 100%! Actual US Pyramid We try again!!! (2011)
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US experience US diet today would be deficient in several micronutrients without contributions of fortification, enrichment and/or supplements Fulgoni et al in press J. Nutrition National Health and Nutrition Examination Survey (NHANES) 2003-6, US population 2 yr and over 17
Risk of deficiency high if many are below estimated average requirement (EAR) Requirement EAR Adverse Effects Frequency Desirable Intake EAR (requirement) Consumption 18 UL 197-01
Risk of deficiency is high when many are below the estimated average requirement (Risky to be below EAR) Requirement EAR Adverse Effects Frequency Desirable Intake EAR (requirement Consumption 19 UL 197-01
% US Population Below the Estimated Average Requirement (EAR) with only contribution of naturally occurring vitamins in foods.nhanes 2003-6 Source: Victor Fulgoni in press 20
% US Population Below EAR with vitamins naturally occurring in foods and nutrients from enriched and fortified foods NHANES 2003-6 ages 2 and ove Victor Fulgoni et al in press
Percent of US Population Below EAR with naturally occurring, fortified and enriched vitamins in foods and dietary supplements. Source: Victor Fulgoni in press 22
% US Population Below EAR for Minerals only from levels naturally occurring in foods NHANES 2003-6 2yr and over Source: fnhanes 2003-6 ages 2 and over Victor Fulgoni in press JN 23
% US Population Below EARs for Minerals: from levels naturally occurring, fortified, and enriched foods Source: Victor Fulgoni in press JN 24
% US Population Below EARs for Minerals from levels naturally occurring, enriched & fortified in foods and supplements Source: Victor Fulgoni in press JN 25
Fortification/enrichment/ supplementation helped in USA Fewer individuals today below Estimated Average Requirement (EAR) and at risk of inadequate intakes few above UL (Upper safe intake Level) 26
% US Population Below the Estimated Average Requirement (EAR) with naturally occurring, fortified and enriched nutrients in foods and dietary supplements. Source: Victor Fulgoni in press 27
US Experience with supplementation mixed Vitamin D Folate Multivitamin-mineral supplements 28
History Vitamin D in USA Early 20 th Century Little UV light winter, smog common in cities Vitamin D rich foods were rare in diet Early 1900 s Targeted infants and children with cod-liver oil (rich in D and A) decreased rickets epidemic But adherence varied and cases continued 30
Vitamin D Problem in infants seemed solved with D fortified milk 1930 s Highly fortified cereals 1970s infant formula D fortified 1978 1970 s and 80 s: osteoporosis/osteomalacia problem in elders Vitamin D Monitoring 1990s- Some deficient? Non-milk drinkers, non-users D fortified cereals - rickets in black breast fed babies - Osteomalaciain elders, shut-ins, chronically ill 31
Hypovitaminosis D in Black women, USA (<37.5 nmol 25 OH D /L) USA 1988-94 NHANES Odell et al AJCN 2002:76:187 Hypovitaminosis D in African Americans associated with Decreased milk and fortified cereal consumption No use D supplements Season, city dwelling 70 60 50 40 30 20 10 0 Percent African Americans Whites 32
Hypovitaminosis D in women 20-49 yr (<37.5 nmol/l) USA 2000-2004 NHANES Looker et al. Am J Clin Nutr 2008;88:1519-27 supplementary tables Was hypovitaminosis D increasing in the USA? Difficult to answer Assay drift Population, survey changes Other factors (sunscreen, etc) 70 60 50 40 30 20 10 0 <---NHANES III Percent African Americans White non Hispanic Mexican American 33
New,Higher 2010 Vitamin D Recommendations USA (based on musculoskeletal endpoints) Age (y) RDA (µg) Pregnancy Lactation Birth to 13 15 (600 IU) 14 70 15 (600 IU) > 70 20 (800 IU) 15 (600 IU) 15 (600 IU) Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes: Calcium, Vitamin D,. Washington, DC: National Academy Press,2010. 34
Supplement D 400 IU and Calcium 1 gm Womens Health Initiative Decreased overall mortality 9% Bone benefit 1.06% increase in hip bone density 12% decrease hip fracture No effect on gastrointestinal symptoms BUT Kidney stones increased 17% Other adverse effects unlikely Subgroups??nonusers at baseline increased CVD (Bollandet al 2011) but were likely different in other ways (use of hormones, smoking et?) 35
D and Calcium Bone Benefit Calcium benefit in Bone Mineral Density among postmenopausal women with over 1 yr treatment; may also protect vs. vertebral fractures 700-800 IU vitamin D and Ca 1000 mg Decreased hip and non-vertebral fractures among adults with low D and Ca at baseline 36
US Vitamin D Experience Fortification of milk works fairly well USA but gaps remain Should D fortification policy be altered? Supplements still needed for those not eating fortified foods - D & Calcium supplements popular in elders But possible toxicity at very high doses of D and Calcium so need for caution 37
Vitamin D Today USA Standard reference material for 25 OHD available clinical tests widely used and finally being standardized Research on extraskeletal effects of D continues We need to avoid going overboard Excess UV light (skin cancer ) and chronic excess D both risky Vitamin D is a hormone, not a panacea 38
Ca and D did not decrease colon cancers Womens Health Initiative (WHI) USA 32,000 women 60-70 yr followed 7yr RCT Ca 1gm and 400IU D /day as a supplement 1.2 1 0.8 0.6 0.4 0.2 0 Colon Cancer Hazard Ratio 39
Difficult to balance risk of deficiency (effectiveness) and risk of excess (safety) Effectiveness Safety 40
Vitamin D: beyond bone Skin Salmon Vitamin D 3 25(OH)D 3 Liver Gland, Breast, Prostate Colon, Lung Kidney Milk Orange juice Calcium Homeostasis Muscle Health Bone Health Supplement Cod liver oil 1,25(OH) 2 D 3 1,25(OH) 2 D 3??????????????????? Blood pressure regulation Cardiovascular Health Immunomodulation (prevention of autoimmune diseases) Regulation of Cell Growth (cancer prevention) 25(OH)D 3 =25-hydroxyvitamin D 3 ; 1,25(OH) 2 D 3 = 1,25-dihydroxyvitamin D 3. Holick MF. Am J Clin Nutr 2004;80(suppl):1678S-88S. 41
Is US Vitamin D Experience Importable to Asia? -Is D deficiency widespread or confined to subgroups? Calcium intakes much lower in Asia Does Calcium need attention? Determine prevalence poor D status Consider targeted supplementation? Monitor results Don t go overboard Absence of evidence acute toxicity doesn t mean chronic use safe at very high doses 42
US Experience: Folate 43
Folate deficiency prevalent in 1/3 women of reproductive age worldwide (15% US women suboptimal status before fortification) Women Increased maternal infections Infertility Megaloblastic anemia of pregnancy (Uncommon in US, common worldwide) Infants Neural Tube Defects Low Birth Weight 44
Neural Tube Defects Anterior neural pore failure to close = anencephaly Posterior neural pore failure to close = spina bifida (70,000 US lifetime cost $0.7M 45
Spina bifida is a neural tube defect USA s most common permanently disabling birth defect 1992: Czeisel prevented with periconceptional folic acid supplements 46
US history folic acid to 1990 Diet suspected as a risk factor but how diet involved unknown (alcohol, potatoes, B vitamin?) 1992 Hungarian randomized clinical trial identified folic acid as preventive 47
US Center for Disease Control (CDC) Recommendation 1992 Women of reproductive age should consume 400 µg of folic acid per day to reduce risk of spina bifida.. MMRW (1992) 41:1-7 48
First we tried nutrition education and dietary changes alone to provide sufficient folate But food folate is less-well absorbed Do you want to eat two pounds of spinach every day?
Then we tried supplements, but daily use of folic acid supplements among women 18 45 in the target group was quite low March of Dimes, 2004
Problem: Many childbearing women stilldid not get enough folic acid So many Neural Tube Defects still occurred 51
Rationale folic acid fortification USA Clear Need Prevalence dietary inadequacy poor nutritional status in population subgroup (women of child-bearing age) and possibly others Clear benefits on Neural Tube Defects Possible benefits on Cardiovascular disease (CVD) in adults, cognition in elders Food vehicle available( wheat flour) Effective and centrally produced Folic acid highly bioavailable Modeling consumption data for folic acid fortification of wheat floursatisfactory possible to achieve EAR and stay below UL see Nut Revs 62: 75 DRI Guiding Principles for Nutrient Labeling and Fortification (IOM report) 52
Neural tube defects declined in USA and Canada after folate fortification Cases/1000 births 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Prefortification Postfortification USA 53 Canada DeWals NEJM 2007:357:135
1998 Folic acid fortification of wheat flour Projected to reduce Neural Tube Defects by 25% Succeeded: 28% reduction in US 46% reduction in Canada Also virtually eliminated folate deficiency Estimated to reduce Cardiovascular CVD deaths in the general population by 5% effects unlikely on CVD, possibly on stroke 54
% of Adults below Folate EAR now is low NHANES USA 2003-6 55
Folic Acid USA Today Folate deficiency gone Little evidence for decreased cardiovascular CVD benefit in general population -but stroke may be decreased UL (upper safe level) may be exceeded by those using many fortified foods plus supplements (also overage in flour fortification, voluntary fortification other products, use of supplements) Monitoring continues 56
Trends in serum folate before and after folic acid fortification,usa 60 3 ng/ml serum folate 50 40 Percent (%) 30 20 10 0 0 5 10 15 20 25 30 35 40 Serum folate (ng/ml) 1988-1994 1999-2000 2001-2002 2003-2004 57
Risk of excess high if many are above Upper safe Level (UL) Requirement EAR Adverse Effects Frequency Desirable Intake EAR (requirement Consumption 58 UL 197-01
Difficult to balance risk of deficiency (effectiveness) and risk of excess (safety) Effectiveness Safety 59
Concerns remain so monitoring continues Fears of increased colon and breast cancer incidence not confirmed recent studies Some studies positive, but data not consistent Folic acid fortification does not seem to be associated with Frequent masking of B 12 deficiency Increase in B-12 related metabolic abnormalities Chemotherapy? Possibly higher levels of anti-folate chemotherapy (methotrexate) for ectopic pregnancy needed in women with higher folate status Little evidence asthma, long term effects in children
Is US Folic Acid Experience Importable to Asia? Neural tube defects are only one problem associated with folic acid in Asia Maternal anemiasdue to folateand B12 deficiency still common some places Other anemias(iron, blood loss, malaria) also problems 61
Is US Experience Importable to Asia? Folate fortification an option if high proportion of population needs Need mandated fortification levels Need enforcementt Large scale fortification of suitable staples now in progress Thailand, Indonesia, others Another option: Targeted Folate or Folate+ Iron supplements targeted to women in reproductive age group may work better in some settings 62
US Experience with Multivitamin mineral supplements to prevent chronic disease 63
Supplement Use Common in USA (NHANES 1999-2002) Sources: Am J Epidemiol 2004;160:339-349 and APAM 2007;161:978-985 64
History US Multivitamin Mineral Supplements (MVM) No standard formulation; Vitamins: most 100% Recommended Dietary Allowance, some higher Minerals: Much lower % RDA (due to bulk) Not always sufficient to prevent deficiency Sometimes recommended medically Pregnancy, frail, chronic illness, vegan Popular-sold as insurance policy vs bad diet & chronic disease 65
MVM use in USA Today The only vitamins and minerals needed are those that are are low in diets Amounts often not enough for specific problems Need unclear: Few supplement users diets from food alone are under estimated average requirement (EAR) Too little of some nutrients, too much of others to help Few users over UL ; mostly users of single high dose or high potency supplements 66
Evidence based review www.ahrq.gov/downloads/pub/br>evidence/pf/multivit.pdf Outside expert panel report http://consensus.nih.gov/2006/mvmfinal051706.pdf 67
Most MVM users healthier than non-users Higher socioeconomic status Healthier habits nonsmokers low BMI, increased physical activity) Already have good diets Few chronic illness or serious disease Cannot say that better health or lower chronic disease due to supplement use in observational studies 68
Latest evidence does not suggest multivitamins decrease chronic disease risk Few effects on overall mortality, cancer or other outcomes among 162,000 postmenopausal women in Womens Health Initiative 40% who used MVM (AJCN 2010) Mortality, cancers or cardiovascular disease no effect in the Multiethnic cohort in Hawaii (Park 2011) Diabetes: no effect (Song et al 2011 Diabetes Care) Cognition-? Effect (Kesse-Gyat 2011) Decreased risk in MVM users after 10 yr without heart disease, but nsd in those with heart disease (Fudys, Sweden) 69
MVM use in healthy people USA Pros Some functional relationships Ca,D May help fulfill some nutritional status needs folic acid in pregnancy low B-12 in elders Convenient Give people a sense of security Cons Only need for nutrients that are low in diets Too little of some micronutrients, too much of others unless tailored to problem Costly if not needed Possibly exceed UL for heavy users of fortified food 70
MVM in USA Today Authoritative bodies do not recommend or discourage general use of MVM Use is not reimbursed in most federal government programs unless physician prescribed costly to consumers if not needed Efficacy in prevention of chronic disease unproven 71
No effects of antioxidants on Cancer Incidence and Mortality Lin et al JNCI 2009: 101: 14 Womens Antioxidant Cardiovascular Study 7627 F, 9.4 yr follow up RCT large doses 500 mg C, 600 IU alpha tocopherol /d and 50 mg beta carotene every other day No effects on cancer incidence or mortality 1.4 1.2 1 0.8 0.6 0.4 0.2 0 C E Beta carotene No significant differences Incidence Mortality 72
Present evidence insufficient to recommend either for or againstuse of multi-vitamin mineral supplements by public to prevent chronic disease 2005 consensus conference But good evidence for some supplements Vitamin D and calcium in elders & D in breast fed infants Folic acid in reproductive age women who do not eat fortified foods Others Iron after 6 months in infants not using fortified formula B12 in elders not using fortified foods Secondary prevention post-bariatric surgery with special supplements, in weight loss,other special indications like age related macular degeneration 73
Is US Experience Importable to Asia? Targeted supplements to prevent specific dietary deficiencies make more sense than MVM Vitamin D and calcium Folateand iron in pregnancy B12 for elders Leave MVM use voluntary? Governments may have better public health nutrition programs than paying for MVM Nutrition education fortification 74
Are dietary supplements needed for healthy dietsand nutritional well being in Asia??? 75
Bottom Line Dietary supplements are rifles, not shotguns! Best tailored to specific sub-population needs May be useful in certainasian countries sometimes for specific purposes Only some US experience importable 76
Place for Supplements in Asia if: Clear Need : diet deficiency in subgroups of population Supplements are Effective(both ideal and actual) Feasible-inexpensive, works In field, available and sustainable Embeddedin broader nutrition, health, development programs Use monitored for effectiveness 77
Consider new information before deciding what role supplements have in Asian diets Pilot studies on fortification and supplements in Asia soon will report results GAIN, many other country efforts at ASN New WHO evidence informed reviews on supplementation and fortification due late 2011-early 2012 78
WHO Guidelines on supplement effects and safety coming (2012) Vitamin D for women during pregnancy for patients with active TB treatment
WHO Guidelines on supplement Iron effects (2012) iron+folic acid for women of reproductive age Iron for infants, young children and preschool age children, women of reproductive age multiple micronutrient supplementation for women in pregnancy in malaria endemic areas (supplements, fortified foods, multiple micronutrient powders) Others Calcium during pregnancy Zinc to improve child growth and other health outcomes
Iron and Folic Acid Supplements to decrease anemia in pregnant women Pros conclusions of Lancet, Innocenti, Copenhagen 2008 60 mg Iron and 400 mcg folic acid to pregnant women decreases anemia (often 3 mo postpartum as well if anemia high) Promising but need more evidence large scale efficacy (effective in Thailand, China) Cons Compliance difficult (women complain of gi distress) Lack of supplies, infrastructure Other anemias also need attention (malaria, bed nets, manage 3 rd stage labor to avoid postpartum hemmorhage etc) Form of iron may not be absorbed (FeEDTA best but costly) 81
WHO Guidelines on Fortification (2012) Multiple MicronutrientPowders (MNPs) given at home to infants, young children, pregnant women Micronutrientpublic health interventions in wheat flour, maize flour, oils, sugar, condiments Iodinefortified salt Zincto improve population health outcomes
Fortification Lancet, Copenhagen, Innocenti 2008 Mass (universal) fortification effective Folic acid(wheat flour or other vehicle delivering enough) Stong evidence impact, effectiveness on large scale Iodization of salt(or other vehicle) Vitamin A fortification (sugar, other vehicle)
Iron Fortification promising but needs more evidence due to low consumption and low bioavailability of iron Lancet, Copenhagen, Innocenti 2008 Pros: Cons Some vehicles like soy sauce and condiments can be fortified with iron at 60-90% EAR with sodium iron EDTA which is highly bioavailable with good effects (China ) Bioavialable form of iron needed Consumption of fortified food needs to be enough to obtain desired intake Need food industry partner, large scale central production
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