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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
Preliminary testing
Prior to the study start, participants will be weighed and body composition will be determined using calipermetry (7 sites) and bioelectrical impedance. Peak oxygen uptake (VO2peak) will be assessed using an incremental exercise test on a bicycle ergometer.
Randomization
Participants will proceed through each of the following conditions lasting 5 days:
CR-LP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be low (0.8 g/kg BW/day).
CR-HP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be high (1.7 g/kg BW/day).
CON: Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Diet Prescription
Dietary energy intake will be controlled using clinical products and maltodextrin to meet target energy intakes. Participants will received calcium and Vitamin D supplementation throughout the study.
Exercise Prescription
During all conditions, participants will conduct daily supervised exercise on a bicycle ergometer at an exercise intensity of 60% VO2peak. Exercise duration will be adjusted individually such that exercise energy expenditure will amount to 15 kcal/kg FFM/day. Additional exercise and intense physical activity will be prohibited.
Assessments
The following assessments will be conducted prior to the start of each condition as well as upon completion of each condition: body weight and composition (impedance), fasting blood draw for assessment of metabolic and anabolic hormones, resting metabolic rate, aerobic fitness (VO2peak), and questionnaires.
Washout
Once a participant has completed a study condition, participant will be allowed a washout of at least 14 days to allow protein balance to return to baseline (Hoffer & Forse, 1990). During this time, participants will resume their regular diet and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric Restriction and High Protein | Experimental | Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. |
|
| Caloric Restriction and Normal Protein | Active Comparator | Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. |
|
| Energy Balance | Placebo Comparator | Participants will be in energy balance and consume 1.7 g protein/kg BW/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric Restriction | Other | Participants will consume 30 kcal/kg FFM/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Metabolic Rate | Baseline and day 6 | |
| Change in Circulating IGF-1 | Baseline and day 6 | |
| Change in Marker of Bone Formation (P1NP) | Baseline and day 6 | |
| Change in Marker of Bone Resorption (CTx) | Baseline and day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Baseline and day 6 | |
| Change in Body Fat Percentage | Baseline and day 6 | |
| Change in Aerobic Fitness (VO2peak) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karsten Koehler, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall | Lincoln | Nebraska | 68583 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17122359 | Background | Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. doi: 10.1210/er.2006-0032. Epub 2006 Nov 22. | |
| 19127177 | Background | 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. |
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Participants Excluded prior to assignment:
n = 4 did not meet inclusion criteria on preliminary questionnaires (n = 1 did not met the age requirements (reported a false age) n = 1 reported hyperthyroidism n = 2 reported insufficient levels of physical activity) n = 1 declined to participate in the study after enrolling
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| ID | Title | Description |
|---|---|---|
| FG000 | (1) CRHP (2) EB (3) CRNP | In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| FG001 | (1) CRHP (2) CRNP (3) EB | In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| FG002 | (1) CRNP (2) EB (3) CRHP | In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| FG003 | (1) CRNP (2) CRHP (3) EB | In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| FG004 | (1) EB (2) CRHP (3) CRNP | In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| FG005 | (1) EB (2) CRNP (3) CRHP | In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (5 Days) |
|
| ||||||||||||||||||
| Washout 1 (14 Days) |
| |||||||||||||||||||
| Intervention 2 (5 Days) |
| |||||||||||||||||||
| Washout 2 (14 Days) |
| |||||||||||||||||||
| Intervention 3 (5 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | (1) CRHP (2) EB (3) CRNP | In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Resting Metabolic Rate | Posted | Mean | Standard Error | kcal change | Baseline and day 6 |
|
During the course of the entire study (~1.5 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caloric Restriction and High Protein | Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. Caloric Restriction: Participants will consume 30 kcal/kg FFM/day. Protein: Participants will consume 1.7 g protein/kg BW/day. Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karsten Koehler | Technical University of Munich | +49 89 289 24488 | karsten.koehler@tum.de |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2019 | Oct 8, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D013217 | Starvation |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D011506 | Proteins |
| D015444 | Exercise |
| D002118 | Calcium |
| D014807 | Vitamin D |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
Not provided
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Not provided
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| Protein | Other | Participants will consume 1.7 g protein/kg BW/day. |
|
| Exercise | Other | Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day |
|
| Calcium and Vitamin D | Dietary Supplement | Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms |
|
| Maltodextrin | Other | Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm |
|
Analyzed in L/min rather than mL/kg/min to remove influence of weight loss. |
| Baseline and day 6 |
| 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 |
| 20591106 | Background | 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. |
| 10865771 | Background | Forbes GB. Body fat content influences the body composition response to nutrition and exercise. Ann N Y Acad Sci. 2000 May;904:359-65. doi: 10.1111/j.1749-6632.2000.tb06482.x. |
| 24595305 | Background | 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. |
| 24945715 | Background | 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. |
| 21177945 | Background | 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. |
| 24307968 | Background | 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. |
| 25614201 | Background | 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. |
| 8772468 | Background | Wade GN, Schneider JE, Li HY. Control of fertility by metabolic cues. Am J Physiol. 1996 Jan;270(1 Pt 1):E1-19. doi: 10.1152/ajpendo.1996.270.1.E1. |
| 14974441 | Background | Loucks AB. Energy balance and body composition in sports and exercise. J Sports Sci. 2004 Jan;22(1):1-14. doi: 10.1080/0264041031000140518. |
| 21228564 | Background | 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. |
| 15231009 | Background | 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. doi: 10.1359/JBMR.040410. Epub 2004 Apr 19. |
| 15659278 | Background | 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. doi: 10.1007/s11932-005-0029-1. |
| 19840876 | Background | Rizzoli R, Bianchi ML, Garabedian 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. |
| 18379214 | Background | 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. |
| 24166063 | Background | 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. |
| 17892378 | Background | 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. doi: 10.1359/jbmr.070907. |
| 21118827 | Background | 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. |
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | (1) CRHP (2) CRNP (3) EB | In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| BG002 | (1) CRNP (2) EB (3) CRHP | In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| BG003 | (1) CRNP (2) CRHP (3) EB | In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| BG004 | (1) EB (2) CRHP (3) CRNP | In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| BG005 | (1) EB (2) CRNP (3) CRHP | In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day. In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day. In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage Body Fat | Mean | Standard Deviation | % body fat |
|
| Aerobic Fitness (VO2max) | Mean | Standard Deviation | mL/kg/min |
|
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. Caloric Restriction: Participants will consume 30 kcal/kg FFM/day. Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm |
| OG002 | Energy Balance | Participants will be in energy balance and consume 1.7 g protein/kg BW/day. Protein: Participants will consume 1.7 g protein/kg BW/day. Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm |
|
|
| Primary | Change in Circulating IGF-1 | All participants completing each condition. | Posted | Mean | Standard Error | mol/L change | Baseline and day 6 |
|
|
|
| Primary | Change in Marker of Bone Formation (P1NP) | Participants who completed all conditions. | Posted | Mean | Standard Error | % change | Baseline and day 6 |
|
|
|
| Primary | Change in Marker of Bone Resorption (CTx) | Posted | Mean | Standard Error | % change | Baseline and day 6 |
|
|
|
| Secondary | Change in Body Weight | Posted | Mean | Standard Error | kg | Baseline and day 6 |
|
|
|
| Secondary | Change in Body Fat Percentage | Due to equipment errors, n = 5 participants had complete body composition data for all conditions. | Posted | Mean | Standard Error | % change | 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. | n = 1 participants had data missing from post-testing in one condition due to equipment failure so their data for the other conditions was removed | Posted | Mean | Standard Error | L/min change | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and day 6 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Caloric Restriction and Normal Protein | Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. Caloric Restriction: Participants will consume 30 kcal/kg FFM/day. Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Energy Balance | Participants will be in energy balance and consume 1.7 g protein/kg BW/day. Protein: Participants will consume 1.7 g protein/kg BW/day. Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm | 0 | 9 | 0 | 9 | 1 | 9 |
Not provided
Not provided
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|