Effects of consuming a high-protein diet with or without soy protein during weight loss and maintenance: a non-inferiority, randomized clinical efficacy trial

K J Speaker, R D Sayer, J C Peters, H N Foley, Z Pan, H R Wyatt, M R Flock, R Mukherjea, J O Hill, K J Speaker, R D Sayer, J C Peters, H N Foley, Z Pan, H R Wyatt, M R Flock, R Mukherjea, J O Hill

Abstract

Objective: This 12-month randomized, non-inferiority clinical trial sought to determine the impact of consuming soy protein as part of an energy-restricted, high-protein diet on weight loss, body composition and cardiometabolic health.

Methods: Seventy-one adults (58 female) with overweight or obesity (body mass index: 32.9 ± 3.6 kg m-2) were randomly assigned to consume three servings of soy (S) or non-soy (NS) protein foods per day for 12 months. All participants completed a group-based behavioural weight loss program lasting 4 months (M4), and follow-up assessments were completed at month 12 (M12).

Results: Body weight was reduced in both groups at M4 (S: -7.0% ± 5.2%, NS: -7.1% ± 5.7%) and M12 (S: 3.6% ± 5.1%, NS: -4.8% ± 7.3%). Body weight reductions (mean difference [90% confidence interval]) were not different between S and NS at either time point (M4: -0.16% [-1.4, 3.6], P = 0.90; M12: 1.1% [-1.4, 3.6], P = 0.44). Differences in body fat mass loss were not different between S and NS at M4 (0.29 ± 0.84 kg, P = 0.73) or M12 (0.78 ± 1.5 kg, P = 0.59). Weight loss-induced improvements in cholesterol, triglycerides and blood pressure did not differ between S and NS.

Conclusion: These results indicate that soy-based protein foods can be effectively incorporated into an energy-restricted, high-protein diet for improving body weight, body composition and cardiometabolic health.

Keywords: Body composition; dietary protein; obesity; weight loss.

Figures

Figure 1
Figure 1
Participant recruitment diagram.
Figure 2
Figure 2
Mean difference in relative weight loss (%) between soy and non‐soy groups relative to the 3% non‐inferiority margin. The intention to treat analysis indicated similar % weight loss at month 4 between soy and non‐soy.

References

    1. Kim JE, O'Connor LE, Sands LP, Slebodnik MB, Campbell WW. Effects of dietary protein intake on body composition changes after weight loss in older adults: a systematic review and meta‐analysis. Nutr Rev 2016; 74: 210–224.
    1. Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp‐Plantenga MS, Luscombe‐Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance [Internet]. Am J Clin Nutr. 2015. p. ajcn084038. Available from:
    1. Wycherley TP, Moran LJ, Clifton PM, Noakes M, Brinkworth GD. Effects of energy‐restricted high‐protein, low‐fat compared with standard‐protein, low‐fat diets: a meta‐analysis of randomized controlled trials. Am J Clin Nutr 2012; 96: 1281–1298.
    1. Halton TL, Hu FB. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr 2004; 23: 373–385.
    1. Sayer RD, Speaker KJ, Pan Z, Peters JC, Wyatt HR, Hill JO. Equivalent reductions in body weight during the Beef WISE Study: beef's role in weight improvement, satisfaction and energy. Obes Sci Pract [Internet] 2017. Available from: 10.1002/osp4.118.
    1. Greco E, Winquist A, Lee TJ, et al. The role of source of protein in regulation of food intake, satiety, body weight and body composition. J Nutr Heal Food Eng [Internet] 2017; 6 Available from: .
    1. Li J, Armstrong CLH, Campbell WW. Effects of dietary protein source and quantity during weight loss on appetite, energy expenditure, and cardio‐metabolic responses. Nutrients 2016; 8: 9–12.
    1. Leidy HJ, Todd CB, Zino AZ, et al. Consuming high‐protein soy snacks affects appetite control, satiety, and diet quality in young people and influences select aspects of mood and cognition. J Nutr [Internet] 2015; 145: 1614–1622. Available from: 10.3945/jn.115.212092.
    1. Leidy HJ, Hoertel HA, Douglas SM, Higgins KA, Shafer RS. A high‐protein breakfast prevents body fat gain, through reductions in daily intake and hunger, in “breakfast skipping” adolescents. Obesity 2015; 23: 1761–1764.
    1. Sucher S, Markova M, Hornemann S, et al. Comparison of the effects of diets high in animal or plant protein on metabolic and cardiovascular markers in type 2 diabetes: a randomized clinical trial. Diabetes Obes Metab 2017; 19: 944–952.
    1. Hauk L. DGAC makes food‐based recommendations in the 2015–2020 dietary guidelines for Americans. Am Fam Physician 2016: 525.
    1. Paul G, Mendelson GJ. Evidence supports the use of soy protein to promote cardiometabolic health and muscle development. J Am Coll Nutr 2015; 34: 56–59.
    1. Tham DM, Gardner CD, Haskell WL. Potential health benefits of dietary phytoestrogens: a review of the clinical, epidemiological, and mechanistic evidence. J Clin Endocrinol Metab 1998: 2223–2235.
    1. Manach C, Milenkovic D, Van de Wiele T, et al. Addressing the inter‐individual variation in response to consumption of plant food bioactives: towards a better understanding of their role in healthy aging and cardiometabolic risk reduction. Mol Nutr Food Res 2017; 61.
    1. Cope MB, Erdman JW, Allison DB. The potential role of soyfoods in weight and adiposity reduction: an evidence‐based review. Obes Rev 2008; 9: 219–235.
    1. Hughes GJ, Ryan DJ, Mukherjea R, Schasteen CS. Protein digestibility‐corrected amino acid scores (PDCAAS) for soy protein isolates and concentrate: criteria for evaluation. J Agric Food Chem 2011; 59: 12707–12712.
    1. Hahn S. Understanding noninferiority trials. Korean J Pediatr [Internet] 2012; 55: 403 Available from: .
    1. Hill JO, Wyatt H, Aschwanden C. State of Slim: Fix Your Metabolism and Drop 20 Pounds in 8 Weeks on the Colorado Diet. Emmaus, Pennsylvania: Rodale; 2013. xx, 268 p.
    1. Morse MH, Haub MD, Evans WJ, Campbell WW. Protein requirement of elderly women: nitrogen balance responses to three levels of protein intake. J Gerontol A Biol Sci Med Sci [Internet] 2001; 56: M724–M730. Available from: .
    1. Kulkarni KR. Cholesterol profile measurement by vertical auto profile method. Clin Lab Med 2006; 26: 787–802.
    1. Craig CL, Marshall AL, Sjöström M, et al. International physical activity questionnaire: 12‐country reliability and validity. Med Sci Sports Exerc 2003; 35: 1381–1395.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – A metadata‐driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377–381.
    1. Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology [Internet] 1990; 1: 43–46. Available from: .
    1. Feise RJ. Do multiple outcome measures require p‐value adjustment? BMC Med Res Methodol [Internet] 2002; 2: 8 Available from: 10.1186/1471-2288-2-8.
    1. Hughes GJ, Kress KS, Armbrecht ES, Mukherjea R, Mattfeldt‐Beman M. Initial investigation of dietitian perception of plant‐based protein quality. Food Sci Nutr [Internet] 2014; 2: 371–379. Available from: .
    1. Kimball SR, Jefferson LS. New functions for amino acids: effects on gene transcription and translation. Am J Clin Nutr [Internet] 2006; 83: 500S–507S. Available from: .
    1. Norton LE, Layman DK. Leucine regulates translation initiation of protein synthesis in skeletal muscle after exercise. J Nutr [Internet] 2006; 136: 533S–537S. Available from: .
    1. Paddon‐Jones D, Sheffield‐Moore M, Zhang X‐J, Volpi E, Wolf SE, Aarsland A, Ferrando AA, Wolfe RR. Amino acid ingestion improves muscle protein synthesis in the young and elderly. Am J Physiol Endocrinol Metab 2004;286:E321–E328.
    1. Tipton KD, Ferrando AA, Phillips SM, Doyle D, Wolfe RR. Postexercise net protein synthesis in human muscle from orally administered amino acids. Am J Physiol [Internet] 1999; 276: E628–E634. Available from: .
    1. Craig WJ, Mangels AR. American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc 2009; 109: 1266–1282.
    1. Kniskern MA, Johnston CS. Protein dietary reference intakes may be inadequate for vegetarians if low amounts of animal protein are consumed. Nutrition [Internet] 2011; 27: 727–730. Available from: .
    1. Dong J‐Y, Tong X, Wu Z‐W, Xun P‐C, He K, Qin L‐Q. Effect of soya protein on blood pressure: a meta‐analysis of randomised controlled trials. Br J Nutr 2011; 106: 317–326.
    1. Ridker P, Bassuk S, Toth P. C‐reactive protein and risk of cardiovascular disease: evidence and clinical application. Curr Atheroscler Rep 2003; 5: 341–349.
    1. Beavers KM, Gordon MM, Easter L, et al. Effect of protein source during weight loss on body composition, cardiometabolic risk and physical performance in abdominally obese, older adults: a pilot feeding study. J Nutr Health Aging [Internet] 2015; 19: 87–95. Available from: .
    1. Franz MJ, VanWormer JJ, Crain AL, et al. Weight‐loss outcomes: a systematic review and meta‐analysis of weight‐loss clinical trials with a minimum 1‐year follow‐up. J Am Diet Assoc 2007; 107: 1755–1767.

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