1. Soy and Health

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, AL
Joyce M. Knestrick, PhD, CRNP, FAANP
Coordinator of Graduate Education- Frontier School of Midwifery and Family Nursing, Hyden, KY
FNP –Primary Care Center of Mt. Morris, PA

4. Disclosures
The faculty have no relationships to disclose.

5. Learning Objectives
On 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 sources
Discuss ways in which soy products can be incorporated in diet
Discuss 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 for
Calorie 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 healthy
30% reportedly seek out soy products
Reported 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 soybeans
Significant portion of US soybeans exported
Soybeans account for 75% of U.S. edible fat and oil consumption
Flakes 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 beans
Higher in calcium and iron than other beans
Lower in B vitamins, crude fiber
Katcher, 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 acid
Omega-6 fatty acids, linolenic acid
Important essential fatty-acids
Must be obtained through diet/intake
Roles in brain function, skin/hair growth, bone health, metabolism peripheral vascular function, reproduction
Katcher, 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 acids
Staple of Asian diet
In U.S. Recommendations often indicate Gm soy protein daily
Katcher, 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 content
25 G soy protein : 100 mg isoflavone
Differs depending on processing, additives, etc.
Estrogen-like activity through selective estrogen receptor modulator (SERM) activity
Act as phytoestrogens
Isoflavone pharmacokinetics:
Peak 5-6 hr after ingestion
Half-life 6-8 hrs
Uptake is saturable, limiting benefit of large consumption
Isoflavone content of foods varies between batches
Setchell, 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 frozen
1 cup= 22 g protein, 12 g fat, 20 g CHO, 8 g fiber, 254 cal
Soybeans: mature beans, ripened dry, varied colors. Can be roasted once soaked; often cooked in soups, stews, etc
1 cup=68g protein, 37 g fat, 56 g CHO, 14 g fiber, 776 cal (roasted)
Soynuts: roasted soybeans; varied flavors available
Soybean oil: natural oil extracted from soybeans; ~75% total US fat/oil consumption; also used in margarine and shortenings
1 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, etc
1 cup=7 g protein, 5 g fat, 8 g cho, 1 g fiber, 109 calories
Tofu: Made from curdled soymilk, soft cheese-like food; bland, variety of uses
1 cup-6 g protein, 2 g fat, 2 g cho, 0 g fiber, 52 cal
Tempeh: Chunky tender soybean cake, used in variety of foods
1 cup-5 g protein, 3 g fat, 3 g cho, 0 g fiber, 55 cal
Miso: Condiment common to Japanese cooking; aged paste of soybean and grain
1 cup=2 g protein, 1 g fat, 5 g cho, 1 g fiber, 40 cal
Soy flour: Ground roasted soybeans; 50% protein, higher protein value if defatted
1 cup=48 g protein, 0 g fat, 27 g cho, 17 g fiber, 394 cal
The 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 Risks
Bone Health
Menopause Symptoms
Heart Disease
Healthy eating

18. Mr. Allen 42 years old weight 280 pounds; 70 inches tall
Last visit 3 months ago weight 310
On a high protein diet for 3 months
Eating mostly meats/salads, very little fish
Becoming bored with diet
Asks about adding soy products to his diet
Has 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 cholesterol
Most recent: TC 210, HDL 35, LDL 125
Watching her diet and increasing exercise
Asks about adding soy to her diet to lower cholesterol
Questions:
How soy works to lower cholesterol
Will products be harmful or make her gain weight
How 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 normal
Has not missed any periods; flow is heavier
Does not want to take any medications for the hot flashes.
Sister- in- law suggested use of soy milk
Has been drinking the soy milk in place of cow’s milk for 3 weeks
Has not noticed any changes in the hot flashes
Would like to continue to try the soy milk
She has less bloating and flatulence since drinking the soy milk
Questions 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/diet
As part of a treatment plan to prevent or treat specific conditions, soy products best considered part of complementary therapy plan
Base responses accordingly

22. Considering Complementary Options
Rakel identifies questions to be considered in recommending “complementary” therapies
Will 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 individualized
Controlled 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 questions
Will review summary literature regarding soy effects related to specific health conditions

25. Regarding Soy and Cancer

26. What Are Effects of Soy on breast and prostate Cancer Risks?
Asian diet includes soy products
Asians have lower rates of breast and prostate cancers
Investigations 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-menopausal
China study failed to demonstrate either relationship
U.S Studies
One 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 women
Inconclusive thus far whether positive benefits
Wu, 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
Isoflavones
SERM activity—theoretical concerns regarding potential role of soy/isoflavone in women at risk for estrogen-sensitive breast cancer
Studies typically measure breast density and/or markers for cancer
No studies have confirmed, but generally advised to counsel women regarding this risk

29. Prostate Cancer Limited human study
Asians lower rate of prostate cancer
US Asian immigrants rate similar to US rate
1989 publication: Tofu consumption associated with marked but not statistically significant decrease in PCA
US study daily soymilk intake associated with decrease incidence PCA
Inadequate research for conclusions
Severson, 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:

30. Regarding Soy and Bone Health

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 similar
Chinese women: higher soy intake associated with decreased fracture risk
RCT demonstrated soy protein associated with decreased bone turnover markers, without density change
Few human studies, which demonstrate inconsistent effects, preliminary
Zhang, 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 ,

32. Regarding Soy and Menopause Symptoms

33. Menopausal Symptoms
Estrogen-like activity of soy attributed to lessening of menopausal symptoms (SERM activity)
Japanese women lower incidence of menopausal symptoms

34. Menopause Evidence
Meta-analysis of 11 studies: mixed results in hot flash reduction
Meta-analysis of 17 studies reduction in women with 10 or more hot flashes/day; no effect if <6 hot flashes/day
Recent RCT soy associated with reduction in women, <4.5/>4.5 hot flashes/day
Other studies have demonstrated similar response to placebo
Nelson, 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. AHRQ
Effects of soy on menopausal symptoms inconsistent, but stronger with isoflavone supplements
Identified study issues include:
Varied symptom scores, score intervals
Decreased weekly frequency reported 7-40%
No apparent effect on menstrual cycles, TSH, bone markers, glucose metabolism
Soy products generally well-tolerated
Balk, 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.

36. Regarding Soy and Heart Effects

37. Hyperlipidemia
FDA 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 RDA
Statement based on review of 27 studies
National 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 levels
Varying results, but generally mildly positive
Anderson, 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 lipids
Intake of g soy protein/day associated with 3-5% reduction in LDL-C
Limited studies yet demonstrating improved long-term outcomes
Only one study (Shanghai Women’s Health Study) provides evidence that increased soy consumption may decrease risk of non-fatal MI and CHD or cardiac events
Zhang, 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 isoflavones
1/3 isoflavones alone
Few protein alone
Mean 36 g/day ( g/day)
36 g=1 # tofu
Balk, 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, etc
Lipids-small benefit on
LDL (mean net change -5 mg/dl)
TG (mean net change -9 mg/dL)
Greater benefit associated with higher baselines and dosages
No significant effect on BP
No significant effect on HDL
Markers of inflammation, vascular function, lipid oxidation
Balk, E. et al (2005).

42. Greater benefit associated with higher baselines and dosages
Whole soy protein greater effect than isoflavone components
Lack of support for soy protein association with decreased cardiac events
Michelfelder, A. (2009). Soy: A complete source of protein. American Family Physician, 79 (1)

43. Regarding Soy as Part of healthy Eating

44. Nutritional Considerations
Vegetarian diets: Soy provides protein substitute for meat and dairy products
Specific Example: Portfolio diet example
Low in saturated fat, high in fiber. Designed to lower cholesterol.
Includes soy, fiber, plant sterols, almonds
Soy protein: 22.5 g/day
Viscous fiber: 10 g/day oats, barley, psyllium-containing cereal
Plant sterol & stanol esters margarine: 1 g/day
Almonds: 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, recommended
Recommends soy products with both protein and isoflavones
Mixed results

46. Potential Adverse Effects
Soy generally well-tolerated
Adverse effects include:
GI symptoms/diarrhea; menstrual complaints
Concern over endometrial hyperplasia, not supported by recent ROL
Potential weak cytochrome P450 3A4 enzyme inducer, with one reported case lowered INR in warfarin patient related to soy milk
Studies indicate addition of soy formulas decrease infant absorption of iron and thyroid supplementation
Infant 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),

47. Revisit Scenarios

48. Mr. Allen 42 years old weight 280 pounds; 70 inches tall
Last visit 3 months ago weight 310
On a high protein diet for 3 months
Eating mostly meats/salads, very little fish
Becoming bored with diet
Asks about adding soy products to his diet
Has heard soy products high in protein and available in varied forms

49. Possible “talking points”
Reinforce ongoing effort and motivation
Because soy is a protein, it makes you feel less hungry after eating
Soy 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 acids
Comparable 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 Suggestions
Tofu: 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 seeds
Soymilk: Soy milk can be substituted for cow’s milk
Soy burgers, soy cheese, and other products can be found in many grocery stores usually in the frozen section
Edamame: 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 cholesterol
Most recent: TC 210, HDL 35, LDL 125
Watching her diet and increasing exercise
Asks about adding soy to her diet to lower cholesterol
Questions:
How soy works to lower cholesterol
Will products be harmful or make her gain weight
How 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 consumption
An 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 benefit
Recommended 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 normal
Has not missed any periods; flow is heavier
Does not want to take any medications for the hot flashes.
Sister- in- law suggested use of soy milk
Has been drinking the soy milk in place of cow’s milk for 3 weeks
Has not noticed any changes in the hot flashes
Would like to continue to try the soy milk
She has less bloating and flatulence since drinking the soy milk
Questions :
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 menopause
Effects 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 related
If no results at higher range, likely will not see response.
Look for results after 4 weeks
Ensure calcium supplementation
Regarding 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 results
Current FDA recommendations to include 25 g of whole soy protein may decrease risk of heart disease
Other potential benefits of soy products may include decreased menopausal hot flashes, maintenance of bone density, and prevention of certain malignancies

56. Summary
A large number of conditions have dietary interventions that should be considered
There is a growing awareness of and interest in soy products
HCPs should be prepared to discuss dietary measures with patients, using an individualized approach and reflecting relevant evidence

57. Post Test
The 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.