Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance

NCT03248804 | Completed

• 1 other identifier: 14-1666
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.

Conditions

Overweight; Obesity; Weight Loss

Keywords

Obesity; Weight Loss; body composition; dietary protein

Outcome Measures

Primary Outcomes (12)

• Change from baseline in % body weight at the end of a 16 week period

  at month 4

• Change from baseline in body fat at the end of 16 week period

  at month 4

• Change from baseline in % body weight at the end of a 52 week period

  at month 12

• Change from baseline in body fat at the end of a 52 week period

  at month 12

• Change from baseline in lipid panel results at end of 16 week period (total cholesterol)

  at month 4

• Change from baseline in lipid panel results at end of 52 week period (total cholesterol)

  at month 12

• Change from baseline in lipid panel results at end of 16 week period (LDL)

  at month 4

• Change from baseline in lipid panel results at end of 52 week period (LDLl)

  at month 12

• Change from baseline in lipid panel results at end of 16 week period (HDL)

  at month 4

• Change from baseline in lipid panel results at end of 52 week period (HDL)

  at month 12

• Change from baseline in lipid panel results at end of 16 week period (triglycerides)

  at month 4

• Change from baseline in lipid panel results at end of 52 week period (triglycerides)

  at month 12

Study Arms (2)

Soy Group

EXPERIMENTAL

Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day.

Behavioral: Soy group

Non-soy Group

OTHER

Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products.

Behavioral: Non-soy group

Interventions

Soy group BEHAVIORAL

Soy Group

Non-soy group BEHAVIORAL

Non-soy Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females ages 18 - 55 years
• BMI between 27-40
• Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
• Generally healthy
• Able to exercise 70 minutes per day at moderate intensity
• Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.

You may not qualify if:

• Pregnant or trying to become pregnant.
• Diagnosis of type 1 or type 2 diabetes
• Individuals following a vegetarian only diet
• Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
• Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
• Known renal disease
• hypothyroidism
• Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
• Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
• LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• DuPont Nutrition and Health: collaborator

Study Sites (1)

University of Colorado Denver, Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Related Publications (24)

• Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.

  PMID: 15051857 BACKGROUND

• Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.

  PMID: 15514267 BACKGROUND

• Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.

  PMID: 7596371 BACKGROUND

• Anthony TG, McDaniel BJ, Knoll P, Bunpo P, Paul GL, McNurlan MA. Feeding meals containing soy or whey protein after exercise stimulates protein synthesis and translation initiation in the skeletal muscle of male rats. J Nutr. 2007 Feb;137(2):357-62. doi: 10.1093/jn/137.2.357.

  PMID: 17237311 BACKGROUND

• Arciero PJ, Baur D, Connelly S, Ormsbee MJ. Timed-daily ingestion of whey protein and exercise training reduces visceral adipose tissue mass and improves insulin resistance: the PRISE study. J Appl Physiol (1985). 2014 Jul 1;117(1):1-10. doi: 10.1152/japplphysiol.00152.2014. Epub 2014 May 15.

  PMID: 24833780 BACKGROUND

• Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr. 2011 Aug;141(8):1489-94. doi: 10.3945/jn.111.139840. Epub 2011 Jun 15.

  PMID: 21677076 BACKGROUND

• Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.

  PMID: 2228407 BACKGROUND

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  PMID: 5524514 BACKGROUND

• Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.

  PMID: 16735482 BACKGROUND

• 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. Nutr J. 2004 Dec 8;3:22. doi: 10.1186/1475-2891-3-22.

  PMID: 15588291 BACKGROUND

• Elia D, Stadler K, Horvath V, Jakus J. Effect of soy- and whey protein-isolate supplemented diet on the redox parameters of trained mice. Eur J Nutr. 2006 Aug;45(5):259-66. doi: 10.1007/s00394-006-0593-z. Epub 2006 Mar 30.

  PMID: 16575496 BACKGROUND

• Kalman D, Feldman S, Martinez M, Krieger DR, Tallon MJ. Effect of protein source and resistance training on body composition and sex hormones. J Int Soc Sports Nutr. 2007 Jul 23;4:4. doi: 10.1186/1550-2783-4-4.

  PMID: 17908338 BACKGROUND

• Latner JD, Schwartz M. The effects of a high-carbohydrate, high-protein or balanced lunch upon later food intake and hunger ratings. Appetite. 1999 Aug;33(1):119-28. doi: 10.1006/appe.1999.0237.

  PMID: 10447984 BACKGROUND

• Marmonier C, Chapelot D, Louis-Sylvestre J. Effects of macronutrient content and energy density of snacks consumed in a satiety state on the onset of the next meal. Appetite. 2000 Apr;34(2):161-8. doi: 10.1006/appe.1999.0302.

  PMID: 10744905 BACKGROUND

• Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.

  PMID: 18469287 BACKGROUND

• Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.

  PMID: 19589961 BACKGROUND

• Porrini M, Santangelo A, Crovetti R, Riso P, Testolin G, Blundell JE. Weight, protein, fat, and timing of preloads affect food intake. Physiol Behav. 1997 Sep;62(3):563-70. doi: 10.1016/s0031-9384(97)00162-5.

  PMID: 9272665 BACKGROUND

• Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.

  PMID: 3212049 BACKGROUND

• Sites CK, Cooper BC, Toth MJ, Gastaldelli A, Arabshahi A, Barnes S. Effect of a daily supplement of soy protein on body composition and insulin secretion in postmenopausal women. Fertil Steril. 2007 Dec;88(6):1609-17. doi: 10.1016/j.fertnstert.2007.01.061. Epub 2007 Apr 6.

  PMID: 17412329 BACKGROUND

• Veldhorst MA, Nieuwenhuizen AG, Hochstenbach-Waelen A, van Vught AJ, Westerterp KR, Engelen MP, Brummer RJ, Deutz NE, Westerterp-Plantenga MS. Dose-dependent satiating effect of whey relative to casein or soy. Physiol Behav. 2009 Mar 23;96(4-5):675-82. doi: 10.1016/j.physbeh.2009.01.004.

  PMID: 19385022 BACKGROUND

• Westerterp-Plantenga MS, Nieuwenhuizen A, Tome D, Soenen S, Westerterp KR. Dietary protein, weight loss, and weight maintenance. Annu Rev Nutr. 2009;29:21-41. doi: 10.1146/annurev-nutr-080508-141056.

  PMID: 19400750 BACKGROUND

• Hill, JH, Blundell, JE. Macronutrients and satiety: The effects of a high-protein or high-carbohydrate meal on subjective motivation to eat and food preferences. Nutr. Behav. 3: 133-144, 1986.

  BACKGROUND

• Peters, JC. Control of Energy Balance. Biochemical, physiological, molecular aspects of human nutrition 2nd edition, M.H. Stipanuk ed. Saunders Elsevier: 618-639, 2006.

  BACKGROUND

• Speaker KJ, Sayer RD, Peters JC, Foley HN, Pan Z, Wyatt HR, Flock MR, Mukherjea R, Hill JO. Effects of consuming a high-protein diet with or without soy protein during weight loss and maintenance: a non-inferiority, randomized clinical efficacy trial. Obes Sci Pract. 2018 May 21;4(4):357-366. doi: 10.1002/osp4.278. eCollection 2018 Aug.

  PMID: 30151230 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• James O Hill, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects are assigned either to the soy group or the non-soy group.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: March 10, 2015
• Primary Completion: October 29, 2016
• Study Completion: October 29, 2016
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)