Weight Loss Clinical Trial
Official title:
Can Increased Dietary Protein Prevent the Suppression of Metabolism and Maintain Anabolic Sensitivity of Bone and Skeletal Muscle During Caloric Restriction?
NCT number | NCT02945410 |
Other study ID # | 15895 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | February 2019 |
Verified date | December 2019 |
Source | University of Nebraska Lincoln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if an increased protein intake can attenuate the suppression of metabolic and anabolic hormones during caloric restriction
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 4 hours/week of purposeful aerobic exercise over the last 3 months - Body mass index: 19-25 kg/m2 - < 15% body fat Exclusion Criteria: - Cardiovascular disease risk factors that would result in greater than low risk - Smoking - Type I, type II diabetes, or history of high fasting glucose; - History of high blood pressure and/or use of medication for hypertension; - History of Dyslipidemia, or on lipid-lowering medication; - Underlying health condition and/or use of medication that could interfere with any of our study outcomes. - History or current diagnosis of a clinical eating disorder - Failure to adhere to study protocol |
Country | Name | City | State |
---|---|---|---|
United States | Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska Lincoln |
United States,
Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4. — View Citation
Carbone JW, Pasiakos SM, Vislocky LM, Anderson JM, Rodriguez NR. Effects of short-term energy deficit on muscle protein breakdown and intramuscular proteolysis in normal-weight young adults. Appl Physiol Nutr Metab. 2014 Aug;39(8):960-8. doi: 10.1139/apnm-2013-0433. Epub 2014 Jun 19. — View Citation
Chevalley T, Bonjour JP, Ferrari S, Rizzoli R. High-protein intake enhances the positive impact of physical activity on BMC in prepubertal boys. J Bone Miner Res. 2008 Jan;23(1):131-42. — View Citation
De Souza MJ, Williams NI. Beyond hypoestrogenism in amenorrheic athletes: energy deficiency as a contributing factor for bone loss. Curr Sports Med Rep. 2005 Feb;4(1):38-44. Review. — View Citation
Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK; American College of Sports Medicine. American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc. 2009 Feb;41(2):459-71. doi: 10.1249/MSS.0b013e3181949333. Erratum in: Med Sci Sports Exerc. 2009 Jul;41(7):1532. — View Citation
Dulloo AG, Jacquet J, Montani JP, Schutz Y. How dieting makes the lean fatter: from a perspective of body composition autoregulation through adipostats and proteinstats awaiting discovery. Obes Rev. 2015 Feb;16 Suppl 1:25-35. doi: 10.1111/obr.12253. Review. — View Citation
Forbes GB. Body fat content influences the body composition response to nutrition and exercise. Ann N Y Acad Sci. 2000 May;904:359-65. Review. — View Citation
Gault ML, Willems ME. Aging, functional capacity and eccentric exercise training. Aging Dis. 2013 Sep 25;4(6):351-63. doi: 10.14336/AD.2013.0400351. Review. — View Citation
Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. Epub 2006 Nov 22. Review. — View Citation
Ihle R, Loucks AB. Dose-response relationships between energy availability and bone turnover in young exercising women. J Bone Miner Res. 2004 Aug;19(8):1231-40. Epub 2004 Apr 19. — View Citation
Loucks AB. Energy balance and body composition in sports and exercise. J Sports Sci. 2004 Jan;22(1):1-14. Review. — View Citation
Misra M, Klibanski A. The neuroendocrine basis of anorexia nervosa and its impact on bone metabolism. Neuroendocrinology. 2011;93(2):65-73. doi: 10.1159/000323771. Epub 2011 Jan 13. Review. — View Citation
Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29. — View Citation
Pikosky MA, Smith TJ, Grediagin A, Castaneda-Sceppa C, Byerley L, Glickman EL, Young AJ. Increased protein maintains nitrogen balance during exercise-induced energy deficit. Med Sci Sports Exerc. 2008 Mar;40(3):505-12. doi: 10.1249/MSS.0b013e31815f6643. — View Citation
Rizzoli R, Bianchi ML, Garabédian M, McKay HA, Moreno LA. Maximizing bone mineral mass gain during growth for the prevention of fractures in the adolescents and the elderly. Bone. 2010 Feb;46(2):294-305. doi: 10.1016/j.bone.2009.10.005. Epub 2009 Oct 17. Review. — View Citation
Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29. — View Citation
Wade GN, Schneider JE, Li HY. Control of fertility by metabolic cues. Am J Physiol. 1996 Jan;270(1 Pt 1):E1-19. Review. — View Citation
Wasserman DH, Kang L, Ayala JE, Fueger PT, Lee-Young RS. The physiological regulation of glucose flux into muscle in vivo. J Exp Biol. 2011 Jan 15;214(Pt 2):254-62. doi: 10.1242/jeb.048041. — View Citation
Weinheimer EM, Sands LP, Campbell WW. A systematic review of the separate and combined effects of energy restriction and exercise on fat-free mass in middle-aged and older adults: implications for sarcopenic obesity. Nutr Rev. 2010 Jul;68(7):375-88. doi: 10.1111/j.1753-4887.2010.00298.x. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Resting Metabolic Rate | Baseline and day 6 | ||
Primary | Change in Circulating IGF-1 | Baseline and day 6 | ||
Primary | Change in Marker of Bone Formation (P1NP) | Baseline and day 6 | ||
Primary | Change in Marker of Bone Resorption (CTx) | Baseline and day 6 | ||
Secondary | Change in Body Weight | Baseline and day 6 | ||
Secondary | Change in Body Fat Percentage | Baseline and day 6 | ||
Secondary | Change in Aerobic Fitness (VO2peak) | Analyzed in L/min rather than mL/kg/min to remove influence of weight loss. | Baseline and day 6 | |
Secondary | Change in Perceived Hunger | Perceived hunger will be assessed using 0-100 visual analog scales. In this case, 100 means maximum hunger while 0 means minimal hunger. | Baseline and day 6 |
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