Soy Protein

 

Soy Protein Clinical Report Summary

 

Soy protein is one of the most highly researched ingredients in the functional foods marketplace with over 50 double-blind, placebo controlled human clinical studies that demonstrate its ability to lower LDL cholesterol, total cholesterol and triglycerides while maintaining HDL cholesterol.  As such, the U.S. Food & Drug Administration has allowed a declaration that "25 grams of soy protein daily may reduce the risk of heart disease."  The FDA singled out 14 studies of particular importance in support of cholesterol reduction (1-14).  Ten additional human clinical studies show soy protein effectiveness in promoting weight loss in individuals on low calorie diets. Other human and animal studies demonstrate that soy protein has beneficial effects on body composition by supporting increases in lean body mass while reducing body fat (15-24).  Soy protein is an excellent protein for athletes that has been shown in human clinical studies to support energy levels, to increase stamina, to promote endurance and to reduce recovery time (25-30). A recent animal study concludes that "soy protein and whey protein are equally beneficial in promoting muscle protein synthesis" (31).  This is a critical measure in strength training, since resistance exercise can disrupt the body's net muscle protein balance for up to 24 hours following exercise. To promote skeletal muscle growth, muscle protein synthesis must exceed muscle protein breakdown.  Two human clinical studies have shown that Soy Protein can help to reduce the risk of bone loss (32-33).  Other human clinicals have shown benefits of soy protein consumption for reducing hot flashes in women during menopause (34-36).  Well over 100 clinical study investigations support the hypothesis that there is a positive correlation between reduced risk of breast, prostate, and gastro-intestinal cancer and the consumption of soy protein-containing foods (37-164).  There is significant scientific agreement among scientists qualified to review this data that soy protein may reduce the risk of some types of cancer.  Numerous other studies show additional potential health benefits of soy protein for issues ranging from diabetes and glycemic control to longevity and liver health (165-178).  A large number of studies report soy formula benefits for infants and young children (ages 2 to 36 months) with diarrhea (179-191).  Children studied experienced fewer bowel movements per day and fewer days of diarrhea.  These studies suggest benefits over other types of formula, including cow milk-based solutions.

 

Soy Protein Overview

It is important to distinguish soy protein from soy isoflavones and the general term "soy" which refers to any food made from soybeans. Among the 3 terms, it is soy protein that is the highly researched functional food ingredient.  Soy protein is actually produced by isolating the highly valuable protein and discarding other bad tasting fats and carbohydrates found in the soybean to create a high protein functional food that scores 100 out of 100 on the PDCAAS scale to measure protein quality.  Its amino acid content is equivalent to the amino acid content of meat and whey protein.  As such, it is an excellent substitute protein to allow adults and children to reduce daily intake of animal meats with high fat content that can be detrimental to heart health and weight management.  It is an excellent protein for athletes because it digests more gradually in the body than whey protein.  Human clinical studies have demonstrated that preserving natural levels of soy isoflavone content in soy protein isolate is essential to delivering cholesterol reduction benefits. (4)  There is no consistent scientific support that concentrated levels of soy isoflavones offer health benefits when extracted from soy foods.  Epidemiological (population) studies have demonstrated significant benefits of soyfood consumption, especially in the Asian culture.  It was this scientific research that led to the identification of soy protein as the critical functional food ingredient.  Epidemiological studies have also established a relationship between consumption of soyfoods and reduced cancer risk in humans.

  

Safe Use of Soy Protein

 

Epidemiological and human clinical studies have established that soy protein and soyfoods, in general, with naturally occurring levels of soy isoflavones, are safe and effective for the general population including use by older adults and young children.  Soy protein use is discouraged in patients with hormone-sensitive malignancies including breast, ovarian, or uterine cancer.  Soy isoflavones are considered "phytoestrogens," that mimic the action of human estrogen; as such, it is appropriate for women cancer patients or others who are prone to cancer to avoid soy foods or supplements with high levels of soy isoflavones.  Patients with these conditions should consult a qualified healthcare provider before use.  Infants suffering from prolonged diarrhea can become dehydrated and develop signs of infection (such as fever).  Parents should consult a physician to determine what feeding practice should be followed.

 

Clinical Studies for Soy Protein 

 

1. Soy Protein Reduces Cholesterol

 

The 1995 Anderson Meta Analysis published in the New England Journal of Medicine definitively established the benefit of cholesterol reduction based on dietary ingestion of isolated Soy Protein:

 

Meta-Analysis of the Effects of Soy Protein Intake on Serum Lipids. Anderson JW, Johnstone BM, Cook-Newall ME.  The New England Journal of Medicine, 1995; 333: 276-282. 

Summary:

• Meta-analysis of the effect of soy protein intake on serum lipids.
• 38 controlled clinical studies
• 743 patients studied 

Results

Total cholesterol:           - 9.3%

LDL cholesterol:             - 12.9%

Triglycerides:                - 10.5%

HDL cholesterol:            + 2.4% (not statistically significant)

Background: In laboratory animals, the consumption of Soy Protein, rather than animal protein, decreases serum cholesterol concentrations, but studies in humans have been inconclusive. In the meta-analysis of 38 controlled clinical trials, we examined the relationship between Soy Protein consumption and serum lipid concentrations in humans. Methods: We used a random-effects model to quantify the average effects of Soy Protein intake on serum lipids in the studies we examined and used hierarchical mixed-effects regression models to predict variation as a function of the characteristics of the studies. Results: In most of the studies, the intake of energy, fat, saturated fat, and cholesterol was similar when the subjects ingested control and soy-containing diets; Soy Protein intake averaged 47 g per day. Ingestion of Soy Protein was associated with the following net changes in serum lipid concentrations from the concentrations reached with the control diet: total cholesterol, a decrease of 0.60 mmol per liter (95% confidence interval, 0.35 to 0.85 mmol per liter), or 9.3 %; low-density lipoprotein (LDL) cholesterol, a decrease of 0.56 mmol per liter (95% confidence interval, 0.30 to 0.82 mmol per liter), or 12.9%; and triglycerides, a decrease of 0.15 mmol per liter (95% confidence interval, 0.003 to 0.29 mmol per liter), or 10.5%. The changes in serum cholesterol and LDL cholesterol concentrations were directly related to the initial serum cholesterol concentration (P<0.001). The ingestion of Soy Protein was associated with a non-significant 2.4 % increase in serum concentrations of high-density lipoprotein (HDL) cholesterol. Conclusions: We found that the consumption of Soy Protein rather than animal protein significantly decreased serum concentrations of total cholesterol, LDL cholesterol, and triglycerides.

 

2. Soy Protein Promotes Lean Body Mass Gain

 

Soy versus whey protein bars: effects on exercise training impact on lean body mass and antioxidant status.  Brown EC, DiSilvestro RA, Babaknia A, Devor ST. Department of Sport & Exercise Sciences, The Ohio State University, Columbus, Ohio, USA. Nutrition Journal 2004; 3:22-26.

Background: Although soy protein may have many health benefits derived from its associated antioxidants, many male exercisers avoid soy protein. This is due partly to a popular, but untested notion that in males, soy is inferior to whey in promoting muscle weight gain. This study provided a direct comparison between a soy product and a whey product.  Methods: Lean body mass gain was examined in males from a university weight training class given daily servings of micronutrient-fortified protein bars containing soy or whey protein (33 g protein/day, 9 weeks, n = 9 for each protein treatment group). Training used workouts with fairly low repetition numbers per set. A control group from the class (N = 9) did the training, but did not consume either type protein bar.  Results: Both the soy and whey treatment groups showed a gain in lean body mass, but the training-only group did not. The whey and training only groups, but not the soy group, showed a potentially deleterious post-training effect on two antioxidant-related related parameters.  Conclusions: Soy and whey protein bar products both promoted exercise training-induced lean body mass gain, but the soy had the added benefit of preserving two aspects of antioxidant function.

 

3. Soy Protein Reduces Bone Loss

 

Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of peri-menopausal women. D Lee Alekel, Alison St Germain, Charles T Peterson, Kathy B Hanson, Jeanne W Stewart and Toshiya Toda from the Department of Food Science and Human Nutrition, Human Metabolic Unit, Center for Designing Foods to Improve Nutrition, the Department of Statistics, Iowa State University, Ames, and the Research and Development Laboratory, Fujicco Co, Ltd, Kobe Hyogo, Japan. American Journal of Clinical Nutrition, Vol. 72, No. 3, 844-852, September 2000. Copyright: 2000 American Society for Clinical Nutrition 

Background: No published studies have directly examined the effect of soy protein with isoflavones on bone or bone turnover in peri-menopausal women.  Objective:e Our objective was to determine the effects of 24 wk of consumption of soy protein isolate with isoflavones (80.4 mg/d) in attenuating bone loss during the menopausal transition.  Design: Peri-menopausal subjects were randomly assigned, double blind, to treatment: isoflavone-rich soy (SPI+; n = 24), isoflavone-poor soy (SPI-; n = 24), or whey (control; n = 21) protein. At baseline and post treatment, lumbar spine bone mineral density (BMD) and bone mineral content (BMC) were measured by using dual-energy X-ray absorptiometry. At baseline, midtreatment, and post treatment, urinary N-telopeptides and serum bone-specific alkaline phosphatase (BAP) were measured.  Results: The percentage change in lumbar spine BMD and BMC, respectively, did not differ from zero in the SPI+ or SPI- groups, but loss occurred in the control group (-1.28%, P = 0.0041; -1.73%, P = 0.0037). By regression analysis, SPI+ treatment had a positive effect on change in BMD (5.6%; P = 0.023) and BMC (10.1%; P = 0.0032). Baseline BMD and BMC (P  0.0001) negatively affected the percentage change in their respective models; baseline body weight (P = 0.0036) and bone-free lean weight (P = 0.016) contributed positively to percentage change in BMD and BMC, respectively. Serum BAP post treatment was negatively related to percentage change in BMD (P = 0.0016) and BMC (P = 0.019). Contrast coding using analyses of covariance with BMD or BMC as the outcome showed that isoflavones, not soy protein, exerted the effect.  Conclusion: Soy isoflavones attenuated bone loss from the lumbar spine in peri-menopausal women.

 

Soy Protein for Heart Health / Reduced Cholesterol References

 

1. Bakhit, R. M., B.P. Klein, D. Essex-Sorlie, J.O. Ham, J.W. Erdman, Jr., and S.M. Potter, "Intake of 25 g of Soybean Protein With or Without Soybean Fiber Alters Plasma Lipids in Men with Elevated Cholesterol Concentrations," Journal of Nutrition, 124: 213-222, 1994.

2. Baum, J.A., H. Teng, J.W. Erdman, Jr., R.M. Weigel, B.P. Klein, V.W. Persky, S. Freels, P. Surya, R.M. Bakhit, E. Ramos, N.F. Shay, and S.M. Potter, "Long-term Intake of Soy Protein Improves Blood Lipid Profiles and Increases Mononuclear Cell LDL Receptor mRNA in Hypercholesterolemic Postmenopausal Women," American Journal of Clinical Nutrition, in press.

3. Carrol , K.K., P.M. Giovannetti, M.W. Huff, O. Moase, D.C.K. Roberts, and B.M. Wolfe, "Hypocholesterolemic Effect of Substituting Soybean Protein for Animal Protein in the Diet of Healthy Young Women," American Journal of Clinical Nutrition, 31: 1312-1321, 1978.

4. Crouse JR III, Morgan TM, Terry JF, J Ellis, et al. A randomized trial comparing the effect of casein with that of soy protein containing varying amounts of isoflavones on plasma concentrations of lipids and lipoproteins. Arch Intern Med 1999;159:2070-2076.

5. Giovannetti, P. M., K. K. Carroll, and B. M. Wolfe, "Constancy of Fasting Serum Cholesterol of Healthy Young Women Upon Substitution of Soy Protein Isolate for Meat and Dairy Protein in Medium and Low Fat Diets," Nutrition Research, 6:609-618, 1986.

6. Goldberg, A. P., A. Lim, J. B. Kolar, J. J. Grundhauser, F. H. Steinke, and G. Schonfeld, "Soybean Protein Independently Lowers Plasma Cholesterol Levels in Primary Hypercholesterolemia," Atherosclerosis, 43:355-368, 1982.

7. Holmes, W. L., G. B. Rubel, and S. S. Hood, "Comparison of the Effect of Dietary Meat Versus Dietary Soybean Protein on Plasma Lipids of Hyperlipidemic Individuals," Atherosclerosis, 36:379-387, 1980.

8. Holmes, W. L., G. B. Rubel, and S. S. Hood, "Comparison of the Effect of Dietary Meat Versus Dietary Soybean Protein on Plasma Lipids of Hyperlipidemic Individuals," Atherosclerosis, 36:379-387, 1980.

9. Kurowska, E. M., J. Jordan, J. D. Spence, S. Wetmore, L. A. Piche, M. Radzikowski, P. Dandona, K. K. Carroll, "Effects of Substituting Dietary Soybean Protein and Oil for Milk Protein and Fat in Subjects With Hypercholesterolemia," Clinical Investigative Medicine, 20(3):162-170, 1997.

10. Mercer, N. J. H., K. K. Carroll, P. M. Giovannetti, F. H. Steinke, and B. M. Wolfe, "Effects on Human Plasma Lipids of Substituting Soybean Protein Isolate for Milk Protein in the Diet," Nutrition Reports International, 35(2):279-287, 1987.

11. Potter, S. M., R. M. Bakhit, D. L. Essex-Sorlie, K. E. Weingartner, K. M. Chapman, R. A. Nelson, M. Prabhudesai, W. D. Savage, A. I. Nelson, L. W. Winter, and J. W. Erdman, Jr., "Depression of Plasma Cholesterol in Men by Consumption of Baked Products Containing Soy Protein," American Journal of Clinical Nutrition, 58:501-506, 1993.

12. Shorey, R. L., B. Bazan, G. S. Lo, and F. H. Steinke, "Determinants of Hypercholesterolemic Response to Soy and Animal Protein-Based Diets," American Journal of Clinical Nutrition, 34:1769-1778, 1981.

13. Van Raaij, J. M. A., M. B. Katan, J. G. A. J. Hautvast, and R. J. J. Hermus, "Effects of Casein Versus Soy Protein Diets on Serum Cholesterol and Lipoproteins in Young Healthy Volunteers," American Journal of Clinical Nutrition, 34:1261-1271, 1981.

14. Van Raaij, J. M. A., M. B. Katan, C. E. West, and J. G. A. J. Hautvast, "Influence of Diets Containing Casein, Soy Isolate, and Soy Concentrate on Serum Cholesterol and Lipoproteins in Middle-aged Volunteers," American Journal of Clinical Nutrition, 35:925-934, 1982. 

 

Soy Protein for Weight Loss / Increased Lean Body Mass References

 
15.  Jenkins, D. J. A., T. M. S. Wolever, G. Spiller, G. Buckley, Y. Lam, A. L. Jenkins, and R. G. Josse, "Hypocholesterolemic Effect of Vegetable Protein in a Hypocaloric Diet," Atherosclerosis, 78:99-107, 1989.

16.  Bosello O, Cominacini L, Zocca I, et al. Short- and long-term effect of hypcaloric diets containing proteins of different sources on plasma lipids and apoproteins of obese subjects. Ann Nutr Metab 1988;32:206-214.

17.  Volgarev MN, Vysotsky VG, Meshcherykova VA, et al. Evaluation of isolated soy protein foods in weight reduction with obese hypercholesterolemic and normocholesterolemic obese individuals. Nutr Rep Int 1989;39:61-71.

18.  Alekel DL(a), HB Hanson, CT Peterson et al. Isoflavone-rich soy favorably affects rise in total body lean mass in menopausal women. FASEB 2000;366.9 A525.

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22.   Arjmandi BH, Alekel L, Hollis BW, et al. Dietary soybean protein prevents bone loss in an ovariectomized rat model of osteoporosis. J Nutr 1996;126:161-67.

23.   Rossi A, Blotstein-Fujii A, DiSilvestro R. Soy beverage consumption by young men increased plasma total antioxidant status and decreased acute, exercise-induced muscle damage. J Nutraceuticals, Functional and Medicinal Foods 2000;2:33-44.5. Blackburn GL. Effect of degree of weight loss on health benefits. Obes Res 1995;3(suppl):211s-216s.

24.   Young VR, Wayler A, Garza C, et al. A long-term metabolic balance study in young men to assess the nutritional quality of an isolated soy protein and beef proteins. Am J Clin Nutr 1984;29:8-15.

 

Soy Protein for Sports Performance References

 

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26.  Brown EC, DiSilvestro RA, Babaknia A, Devor ST. Soy versus whey protein bars: effects on exercise training impact on lean body mass and antioxidant status. Nutrition Journal 2004; 3:22-26.

27.  Cancer Lett 2001 Oct 22;172(1):1-6. Effect of soy isoflavone supplementation on markers of oxidative stress in men and women. Djuric Z, et al. Barbara Ann Karmanos Cancer Institute, MI.

28.  Hill S, Box W, DiSilvestro RA. Moderate intensity resistance exercise, plus or minus soy intake: effects on serum lipids peroxides in young adult males. International Journal of Sport Nutrition and Exercise Metabolism 2004; 14:125-132.

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30.  Rossi A, DiSilvestro RA, Blostein-Fujii. 1998. "Effects of soy consumption on exercise induced acute muscle damage and oxidative stress in young adult males." FASEB, vol 12:5 p. A653.

31.  Anthony T, McDaniel B, Knoll P, Bunpo P, Paul G, McNurlan M. 2007. Feeding Meals Containing Soy or Whey Protein after Exercise Stimulates Protein Synthesis and Translation Initiation in the Skeletal Muscle of Male Rats. J. Nutr. 137: 357-362.

 

Soy Protein for Bone Loss References

 

32.  Alekel DL(b), St. Germain A, Peterson CT, et al. Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of peri-menopausal women. American Journal of Clinical  Nutrition 2000;72:844-852.

33.  Potter SM, Baum JA, Teng H, et al. Soy protein and isoflavones: Their effects on blood lipids and bone density in post-menopausal women. American Journal of Clinical Nutrition 1998;68(suppl):1375S-1379S.

 

Soy Protein for Reduced Hot Flashes in Menopause References

 

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36.  Washburn S, Burke GL, Morgan T, et al. Effect of soy protein supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in peri-menopausal women.

 

Soy Protein for Reduced Risk of Cancer References

 

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