2 This activity is partially supported by educational funding received from the United Soybean Board. Printable handout available at AANP CE Center.
3 Faculty Cindy Cooke MSN, NP-C, FAANP FNP - Fox Army Health Center, Huntsville, ALJoyce M. Knestrick, PhD, CRNP, FAANPCoordinator of Graduate Education- Frontier School of Midwifery and Family Nursing, Hyden, KYFNP –Primary Care Center of Mt. Morris, PA
4 DisclosuresThe faculty have no relationships to disclose.
5 Learning ObjectivesOn completion of this activity, participants will be able to:Discuss the nutrients available in soy products.Identify sources of soy and the nutritional value of various sourcesDiscuss ways in which soy products can be incorporated in dietDiscuss recommendations and supporting evidence regarding soy as relates to specific conditions
6 Consumers and nutritional information 88% of consumers report reviewing Nutrition Facts panel when purchasing food.48% of consumers find nutrition information confusing.Most frequently consumers look forCalorie content (16%)Fat content (11%)United Soybean Board (2009). 16th annual survey: Consumer attitudes about nutrition.
7 Consumer Soy Knowledge 84% respondents rate soy products as healthy30% reportedly seek out soy productsReported benefits:Low fat (19%)Good protein source (18%)Associated with reduced rate of heart disease (18%)Associated with lowered cholesterol (13%)
8 Source of Soy Knowledge Reported sources of information regarding health and nutrition information on soy:HCPs 16%Internet 42%Television 41%Magazines 40%Need for HCPs to be informed regarding soy and other dietary factors, to provide individualized instruction
9 Soy Production Details US produces 42% of world’s soybeansSignificant portion of US soybeans exportedSoybeans account for 75% of U.S. edible fat and oil consumptionFlakes remaining after oil extraction used to produce wide range of high protein products
10 SoyBean Beans generally good source of nutrients Soybeans include 47% fat energy, higher than other beansHigher in calcium and iron than other beansLower in B vitamins, crude fiberKatcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38,
11 soyfat Mono and Poly unsaturated No cholesterol Omega-3 fatty acid, alpha-linolenic acidOmega-6 fatty acids, linolenic acidImportant essential fatty-acidsMust be obtained through diet/intakeRoles in brain function, skin/hair growth, bone health, metabolism peripheral vascular function, reproductionKatcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38,Both Omega 6 and Omega 3 fatty acides are good sources of essential fatty acides.
12 Protein Vegetarian source of total protein 36% of the total bean Contains all essential amino acidsStaple of Asian dietIn U.S. Recommendations often indicate Gm soy protein dailyKatcher, H., Hill, A., Lanford, J., Yoo, J., Kris-Etherton, P. (2009). Lifestyle approaches and dietary strategies to lower LDL-cholesterol and triglycerides and raise HDL-cholesterol. Endocrinology and metabolism clinics of North America, 38,
13 Concentrated Soy Sources Concentrated sources of soy protein include:Soy protein powder (80-90%)Soy nuts (40%)Full-fat soy flour (35%)To consume 50 gm/day—example:1 soy breakfast patty, 8 oz soy milk, 3 oz tofu, 1 oz soy nuts, 2 heaping tablespoons of soy protein
14 Soy Intake and isoflavones Soy products vary in isoflavone content25 G soy protein : 100 mg isoflavoneDiffers depending on processing, additives, etc.Estrogen-like activity through selective estrogen receptor modulator (SERM) activityAct as phytoestrogensIsoflavone pharmacokinetics:Peak 5-6 hr after ingestionHalf-life 6-8 hrsUptake is saturable, limiting benefit of large consumptionIsoflavone content of foods varies between batchesSetchell, K. (2001). Soy isoflavones—Benefits and risks from nature’s selected estrogen receptor modulators (SERMs), Journal of the American College of Nutrition, 20 (5), 354S-362S.
15 Common Soy Products: Glossary & Nutrition Edamame: Large soybeans harvested while green; boiled minutes can be served as snack or vegetable; available shelled and in pods; available fresh and frozen1 cup= 22 g protein, 12 g fat, 20 g CHO, 8 g fiber, 254 calSoybeans: mature beans, ripened dry, varied colors. Can be roasted once soaked; often cooked in soups, stews, etc1 cup=68g protein, 37 g fat, 56 g CHO, 14 g fiber, 776 cal (roasted)Soynuts: roasted soybeans; varied flavors availableSoybean oil: natural oil extracted from soybeans; ~75% total US fat/oil consumption; also used in margarine and shortenings1 cup=0 g protein, 218 g fat, 0 g CHO, 0 g fibre, 1664 cal
16 Common Soy Products: Glossary & Nutrition Soymilk: Made from soybeans soaked, ground, and strained; found in unrefrigerated section and refrigerated dairy cases; also used to make soy yogurt, soy cheese, etc1 cup=7 g protein, 5 g fat, 8 g cho, 1 g fiber, 109 caloriesTofu: Made from curdled soymilk, soft cheese-like food; bland, variety of uses1 cup-6 g protein, 2 g fat, 2 g cho, 0 g fiber, 52 calTempeh: Chunky tender soybean cake, used in variety of foods1 cup-5 g protein, 3 g fat, 3 g cho, 0 g fiber, 55 calMiso: Condiment common to Japanese cooking; aged paste of soybean and grain1 cup=2 g protein, 1 g fat, 5 g cho, 1 g fiber, 40 calSoy flour: Ground roasted soybeans; 50% protein, higher protein value if defatted1 cup=48 g protein, 0 g fat, 27 g cho, 17 g fiber, 394 calThe following couple of slides depict the range of soy foods. And some of the related nutritional values. The actual isoflavone content of soy foods varies dependiing on variables such as how it is processed, the presence of additives, etc. Ideal to consider specific foods rather than broad categories.
17 Health Effects/Claims Cancer RisksBone HealthMenopause SymptomsHeart DiseaseHealthy eating
18 Mr. Allen 42 years old weight 280 pounds; 70 inches tall Last visit 3 months ago weight 310On a high protein diet for 3 monthsEating mostly meats/salads, very little fishBecoming bored with dietAsks about adding soy products to his dietHas heard soy products high in protein and available in varied forms
19 Mrs. Comer 48 years old Weight 158 pounds; height 5’4” Concerned about her cholesterolMost recent: TC 210, HDL 35, LDL 125Watching her diet and increasing exerciseAsks about adding soy to her diet to lower cholesterolQuestions:How soy works to lower cholesterolWill products be harmful or make her gain weightHow much soy would need to be consumed to help lower her cholesterol.
20 Mrs. Rick 50 years old, with complaints of hot flashes Last pap smear normalHas not missed any periods; flow is heavierDoes not want to take any medications for the hot flashes.Sister- in- law suggested use of soy milkHas been drinking the soy milk in place of cow’s milk for 3 weeksHas not noticed any changes in the hot flashesWould like to continue to try the soy milkShe has less bloating and flatulence since drinking the soy milkQuestions if the substitution of soy milk in place of cow’s milk will have an effect on her bones.
21 How to Respond to patients? As part of healthy diet, soy products considered part of nutrition/dietAs part of a treatment plan to prevent or treat specific conditions, soy products best considered part of complementary therapy planBase responses accordingly
22 Considering Complementary Options Rakel identifies questions to be considered in recommending “complementary” therapiesWill the therapy result in resolution or symptom suppression?What is the evidence?What is the potential harm?What is the cost?Does the treatment fit patient’s culture and belief system?Rakel, D. (2006). Complementary medicine in clinical practice. Philadelphia: Elsevier.Clearly, need to consider the benefit to risk ration, the cost including the difficulty and time required, etc
23 Challenges Regarding Evidence Regarding the evidence-base for integrative or complementary measures, Rakel identifies challenges, including:Clinical trials typically measure response to one treatment, while integrative measures usually part of a “package”Many integrative measures are not administered in one standardized portion, but individualizedControlled studies often look at short-term outcomes rather than long-term
24 More information needed In order to consider use of soy products as part of complementary treatment plan, must consider the evidence to help answer questionsWill review summary literature regarding soy effects related to specific health conditions
26 What Are Effects of Soy on breast and prostate Cancer Risks? Asian diet includes soy productsAsians have lower rates of breast and prostate cancersInvestigations of effects of soy in cancer risk are limited
27 Breast Cancer Asian studies U.S Studies A Singapore and a Japan study each found soyfoods consumption associated with lower rate of BCA in pre-menopausal females, not in post-menopausalChina study failed to demonstrate either relationshipU.S StudiesOne US trial demonstrated protective relationship only in women born in Asia who migrated to U.S.Meta-analysis of 18 studies cite decreased breast cancer associated with higher soy consumption, strongest in post-menopausal womenInconclusive thus far whether positive benefitsWu, A.,et al (2008). Soy intake and breast cancer risk in Singapore Chinese Health Study. British Journal of Cancer ,99:Qin, L., Xu, J., & Wan, P. (2006). Soyfood intake in the prevention of breast cancer risk in women: A meta-analysis of observational epidemiological studies. Journal of Nutritional Science, 52 (6), cited in Michelfelder 92009). Soy: A complete source of Protein, 79 (1),Trock, B., Hilakivi-Clarke, Ll, & Clarke, R. (2006). Meta-analysis of soy intake and breast cancer risk. Journal of the American Cancer Institute, 98 (7),
28 Concerns Related to Soy and Estrogen-Sensitive Cancer IsoflavonesSERM activity—theoretical concerns regarding potential role of soy/isoflavone in women at risk for estrogen-sensitive breast cancerStudies typically measure breast density and/or markers for cancerNo studies have confirmed, but generally advised to counsel women regarding this risk
29 Prostate Cancer Limited human study Asians lower rate of prostate cancerUS Asian immigrants rate similar to US rate1989 publication: Tofu consumption associated with marked but not statistically significant decrease in PCAUS study daily soymilk intake associated with decrease incidence PCAInadequate research for conclusionsSeverson, R., et al (1989). A propsiective study of demgraphis, diet, and prostate cancer amon men of Japanese ancestry in Hawaii. Cancer Research, 49,Jacobsen BK et al . (1998) Does high soy milk reduce prostate cancer incidence? The Adventist Health Study (United States). Cancer Causes Control 9:
31 Soy Bone Health Japanese women lower rate of hip fractures Lower rate could be due to anatomical differences or fall risk, as bone density similarChinese women: higher soy intake associated with decreased fracture riskRCT demonstrated soy protein associated with decreased bone turnover markers, without density changeFew human studies, which demonstrate inconsistent effects, preliminaryZhang, X., et al (2005). Prospective cohort study of soy food consumption and risk of bone fracture among postmenopausal women. Archives of Internal Medicine, 166 (16),Evans et al (2007). Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women. Menopause ,
33 Menopausal SymptomsEstrogen-like activity of soy attributed to lessening of menopausal symptoms (SERM activity)Japanese women lower incidence of menopausal symptoms
34 Menopause EvidenceMeta-analysis of 11 studies: mixed results in hot flash reductionMeta-analysis of 17 studies reduction in women with 10 or more hot flashes/day; no effect if <6 hot flashes/dayRecent RCT soy associated with reduction in women, <4.5/>4.5 hot flashes/dayOther studies have demonstrated similar response to placeboNelson, et al. (2006). Nonhormonal therapies for menopausal hot flashes: Systematic review and meta-analysis. JAMA (295 (17),Howes, L., Howes, J., & Knight, D. (2006). Isoflavone therapy for menopausal flashes: A systematic review and meta-analysis. Maturitas, 55 (3),Weity, F, et al (2007). Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women. Menopause, 15 (1),Newton, K., et al (2006). Treatment of vasomotor symptoms of menopause with black cohosh, mutibotanicals, soy, hormone therapy, or placebo: A randomized trail. Annals of Internal Medicine 145 (12),
35 AHRQEffects of soy on menopausal symptoms inconsistent, but stronger with isoflavone supplementsIdentified study issues include:Varied symptom scores, score intervalsDecreased weekly frequency reported 7-40%No apparent effect on menstrual cycles, TSH, bone markers, glucose metabolismSoy products generally well-toleratedBalk, E. et al (2005). Effects of Soy on Health Outcomes. Evidence Report/Technology Assessment No (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract No ) AHRQ Publication No. 05-E Rockville, MD: Agency for Healthcare Research and Quality.
37 HyperlipidemiaFDA approved health claim: “Diets low in saturated fats and cholesterol that include 25 g of soy protein a day may reduce the risk of heart disease”To qualify for claim, food must contain at least 6.25 g soy protein, or 25% of RDAStatement based on review of 27 studiesNational Cholesterol Education Program recommends soy protein as replacement for higher-fat animal proteins
38 Soy & Lipids: Body of Evidence Four meta-analyses demonstrated statistically significant reduction in TC up to 9.3%, with greater effect associated with higher starting TC levelsVarying results, but generally mildly positiveAnderson, J., Johnstone, B., Cook-Newell, M (1999). Meta-analysis of the effects of soy protein intake on serum lipids. NEJM, 333 (5),Nies, L.,Cymbalta, A., Kasten S., et al (2006). Complementary and alternative therapies for the management of serum lipids. Annala of Pharmacotherapy, 40(11),Reynolds, K., et al (2006). A meta-analysis of the effect of soy protein supplementation on serum lipids. American Journal of Cardiology, 98 (5),Zhua, X., Melby, M., & Watanabe, S. 2004). Soy isoflavone intake lowers serum LDL cholesterol: A meta-analysis. Journal of Nutrition, 134 (9),
39 Limited studies yet demonstrating improved long-term outcomes More recent meta-analyses demonstrated more modest, but favorable effects on lipidsIntake of g soy protein/day associated with 3-5% reduction in LDL-CLimited studies yet demonstrating improved long-term outcomesOnly one study (Shanghai Women’s Health Study) provides evidence that increased soy consumption may decrease risk of non-fatal MI and CHD or cardiac eventsZhang, et al (2003). Soy food consumption is associated with lower risk of coronary heart disease in Chinese women. Journal of Nutrition, 133,
40 AHRQ Meta-analysis 178 eligible articles Supplements (including soy milk) in 75%Soy foods (soy flour and textured soy protein) 25%Most soy protein with isoflavones1/3 isoflavones aloneFew protein aloneMean 36 g/day ( g/day)36 g=1 # tofuBalk, E. et al (2005). Effects of Soy on Health Outcomes. Evidence Report/Technology Assessment No (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract No ) AHRQ Publication No. 05-E Rockville, MD: Agency for Healthcare Research and Quality.
41 Issues related to soy-heart studies Heterogenicity in types of soy, doses, durations, etcLipids-small benefit onLDL (mean net change -5 mg/dl)TG (mean net change -9 mg/dL)Greater benefit associated with higher baselines and dosagesNo significant effect onBPNo significant effect on HDLMarkers of inflammation, vascular function, lipid oxidationBalk, E. et al (2005).
42 Greater benefit associated with higher baselines and dosages Whole soy protein greater effect than isoflavone componentsLack of support for soy protein association with decreased cardiac eventsMichelfelder, A. (2009). Soy: A complete source of protein. American Family Physician, 79 (1)
44 Nutritional Considerations Vegetarian diets: Soy provides protein substitute for meat and dairy productsSpecific Example: Portfolio diet exampleLow in saturated fat, high in fiber. Designed to lower cholesterol.Includes soy, fiber, plant sterols, almondsSoy protein: 22.5 g/dayViscous fiber: 10 g/day oats, barley, psyllium-containing cerealPlant sterol & stanol esters margarine: 1 g/dayAlmonds: 15 nuts/day
45 Rakel considers the level of evidence and reported benefits for use of soy and fiber in nutritional impact on lipids, as well as potential risks/hazards.Reported benefit with limited risk, recommendedRecommends soy products with both protein and isoflavonesMixed results
46 Potential Adverse Effects Soy generally well-toleratedAdverse effects include:GI symptoms/diarrhea; menstrual complaintsConcern over endometrial hyperplasia, not supported by recent ROLPotential weak cytochrome P450 3A4 enzyme inducer, with one reported case lowered INR in warfarin patient related to soy milkStudies indicate addition of soy formulas decrease infant absorption of iron and thyroid supplementationInfant soy allergy rate 1% on soy formula; adult soy allergy rate 0.2%Michelfelder, A. (2009). Soy: A complete source of protein. American Family Physician, 79 (1),
48 Mr. Allen 42 years old weight 280 pounds; 70 inches tall Last visit 3 months ago weight 310On a high protein diet for 3 monthsEating mostly meats/salads, very little fishBecoming bored with dietAsks about adding soy products to his dietHas heard soy products high in protein and available in varied forms
49 Possible “talking points” Reinforce ongoing effort and motivationBecause soy is a protein, it makes you feel less hungry after eatingSoy protein is “low-carb.” Soybeans are the only vegetable that contain more protein than carbohydrates.Soy protein has a ”low-glycemic index” that helps with appetite and weight loss.Soy protein contains all 9 essential amino acidsComparable to meat with less fat and fewer calories. Discuss the advantages of using soy products in a high protein diet.Discuss potential ways in which soy can be incorporated into diet
50 Some Soy SuggestionsTofu: Is often used in stir-fries, curries or stews. It tends to pick up the flavor of the sauce it is in.Soy nuts: Can be used as a snack similar to peanuts or sunflower seedsSoymilk: Soy milk can be substituted for cow’s milkSoy burgers, soy cheese, and other products can be found in many grocery stores usually in the frozen sectionEdamame: Sold frozen or fresh the beans can be microwaved or simmered.Tempeh: It can be used as a meat substitute, and works well in spaghetti sauce.Miso: It can be used for soup stocks or as a seasoning.
51 Mrs. Comer 48 years old Weight 158 pounds; height 5’4” Concerned about her cholesterolMost recent: TC 210, HDL 35, LDL 125Watching her diet and increasing exerciseAsks about adding soy to her diet to lower cholesterolQuestions:How soy works to lower cholesterolWill products be harmful or make her gain weightHow much soy would need to be consumed to help lower her cholesterol.
52 Potential “talking points” The studies related to the benefits of soy to lower cholesterol are mixed.Discuss the affects of Soy Products on weight loss or weight gain. The addition of Soy Products in place of animal protein can lead to a reduction of weight with decreased calorie/fat consumptionAn excess intake of any food can lead to weight gain. Define the amount of Soy Products that should be consumed in a healthy diet.Individualized ----Some studies involved very large quantities of soy foods for benefitRecommended daily intake of soy products must be reasonable Soybeans offer a complete protein with nine essential amino acids; recommendation to substitute soy in place of mean/animal protein
53 Mrs. Rick 50 years old, with complaints of hot flashes Questions : Last pap smear normalHas not missed any periods; flow is heavierDoes not want to take any medications for the hot flashes.Sister- in- law suggested use of soy milkHas been drinking the soy milk in place of cow’s milk for 3 weeksHas not noticed any changes in the hot flashesWould like to continue to try the soy milkShe has less bloating and flatulence since drinking the soy milkQuestions :Will substitution of soy milk for cow’s milk have an effect on her bones.Is there any evidence to support the use of soy products to alleviate her peri-menopausal symptoms?How long would she have to use the soy products before noticing a difference.
54 Potential “talking points” Two soy isoflavones (genistein and diadzein) believed to help the symptoms associated with peri- menopause and menopauseEffects of soy on menopausal symptoms inconsistent, but decreased weekly frequency 7-40% Actions believed to related to SERM activity, blocking the negative effects of estrogen. The North American Menopause Society supports eating whole foods containing the following mg/day of isoflavones to reduce hot flashes (3- 4 glasses/day soy milk)Effects stronger with isoflavone supplements and dose relatedIf no results at higher range, likely will not see response.Look for results after 4 weeksEnsure calcium supplementationRegarding the changes in her GI tract since switching to soy milk: may have improved some previously undiagnosed lactose intolerance. Increased amounts of soy milk could cause digestive problems similar to ingestion of other legumes.
55 Summary Soybeans provide a high protein, low fat option Studies regarding the dietary effects of soybeans and soy products on specific conditions heterogeneous with varied resultsCurrent FDA recommendations to include 25 g of whole soy protein may decrease risk of heart diseaseOther potential benefits of soy products may include decreased menopausal hot flashes, maintenance of bone density, and prevention of certain malignancies
56 SummaryA large number of conditions have dietary interventions that should be consideredThere is a growing awareness of and interest in soy productsHCPs should be prepared to discuss dietary measures with patients, using an individualized approach and reflecting relevant evidence
57 Post TestThe post-test for this activity is located on the AANP CE Center.Credit earned by successful completion of the online post-test.70% or higher score required.
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