Weight LossNCT02945410
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
A study testing Caloric Restriction, Protein and Exercise in people with Weight Loss and Starvation, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Starvation
- What is being tested?
- Caloric Restriction, Protein and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 4 hours/week of purposeful aerobic exercise over the last 3 months
- Body mass index: 19-25 kg/m2
- < 15% body fat
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall
Lincoln, Nebraska, 68583
About this study
Official title: Can Increased Dietary Protein Prevent the Suppression of Metabolism and Maintain Anabolic Sensitivity of Bone and Skeletal Muscle During Caloric Restriction?
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
Read the detailed description
- 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.
- Conditions
- Weight Loss, Starvation
- Being tested
- Caloric Restriction, Protein, Exercise, Calcium and Vitamin D, Maltodextrin
- Medical subject headings
- Weight Loss, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RestrictionOther
Participants will consume 30 kcal/kg FFM/day.
ProteinOther
Participants will consume 1.7 g protein/kg BW/day.
ExerciseOther
Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin DDietary supplement
Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
MaltodextrinOther
Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Caloric Restriction; Other: Protein; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin |
| 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. Receives: Other: Caloric Restriction; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin |
| Energy Balance | Placebo comparator | Participants will be in energy balance and consume 1.7 g protein/kg BW/day. Receives: Other: Protein; Other: Exercise; Dietary Supplement: Calcium and Vitamin D; Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Resting Metabolic Rate
Measured: Baseline and day 6
Change in Circulating IGF-1
Measured: Baseline and day 6
Change in Marker of Bone Formation (P1NP)
Measured: Baseline and day 6
Change in Marker of Bone Resorption (CTx)
Measured: Baseline and day 6
Secondary outcomes (4)
Change in Body Weight
Measured: Baseline and day 6
Change in Body Fat Percentage
Measured: Baseline and day 6
Change in Aerobic Fitness (VO2peak)
Analyzed in L/min rather than mL/kg/min to remove influence of weight loss.
Measured: 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.
Measured: Baseline and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karsten Koehler, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945410
- Sponsor's protocol ID
- 15895
- Status last verified
- Dec 2019
- First submitted
- 10 Oct 2016
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17122359Donnelly 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.
PubMed 19127177Weinheimer 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.
PubMed 20591106Forbes 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.
PubMed 10865771Areta 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.
PubMed 24595305Carbone 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.
PubMed 24945715Wasserman 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.
PubMed 21177945Gault 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.
PubMed 24307968Dulloo 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.
PubMed 25614201Wade 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.
PubMed 8772468Loucks AB. Energy balance and body composition in sports and exercise. J Sports Sci. 2004 Jan;22(1):1-14. doi: 10.1080/0264041031000140518.
PubMed 14974441Misra 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.
PubMed 21228564Ihle 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.
PubMed 15231009De 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.
PubMed 15659278Rizzoli 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.
PubMed 19840876
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Increased Dietary Protein Prevent the Suppression of Metabolism and Maintain Anabolic Sensitivity of Bone and Skeletal Muscle During Caloric Restriction?
- ClinicalTrials.gov ID
- NCT02945410
- Acronym / sponsor ID
- 15895
- Conditions
- Weight Loss, Starvation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caloric Restriction and High Protein | Experimental | Other: Caloric Restriction, Other: Protein, Other: Exercise, Dietary Supplement: Calcium and Vitamin D, Other: MaltodextrinParticipants 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 | Other: Caloric Restriction, Other: Exercise, Dietary Supplement: Calcium and Vitamin D, Other: MaltodextrinParticipants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day. |
| Energy Balance | Placebo comparator | Other: Protein, Other: Exercise, Dietary Supplement: Calcium and Vitamin D, Other: MaltodextrinParticipants will be in energy balance and consume 1.7 g protein/kg BW/day. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 4 hours/week of purposeful aerobic exercise over the last 3 months
- Body mass index: 19-25 kg/m2
- < 15% body fat
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric RestrictionParticipants will consume 30 kcal/kg FFM/day. | Other | Caloric Restriction and High Protein, Caloric Restriction and Normal Protein |
| ProteinParticipants will consume 1.7 g protein/kg BW/day. | Other | Caloric Restriction and High Protein, Energy Balance |
| ExerciseParticipants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day | Other | Caloric Restriction and High Protein, Caloric Restriction and Normal Protein, Energy Balance |
| Calcium and Vitamin DParticipants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms | Dietary supplement | Caloric Restriction and High Protein, Caloric Restriction and Normal Protein, Energy Balance |
| MaltodextrinParticipants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm | Other | Caloric Restriction and High Protein, Caloric Restriction and Normal Protein, Energy Balance |
Primary outcome
Change in Resting Metabolic Rate
Time frame: Baseline and day 6
Change in Circulating IGF-1
Time frame: Baseline and day 6
Change in Marker of Bone Formation (P1NP)
Time frame: Baseline and day 6
Change in Marker of Bone Resorption (CTx)
Time frame: Baseline and day 6
4 secondary outcomes
Change in Body Weight
Time frame: Baseline and day 6
Change in Body Fat Percentage
Time frame: Baseline and day 6
Change in Aerobic Fitness (VO2peak)
Time frame: Baseline and day 6
Change in Perceived Hunger
Time frame: Baseline and day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17122359Hill 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.
- Background: PubMed 19127177Donnelly 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.
- Background: PubMed 20591106Weinheimer 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.
- Background: PubMed 10865771Forbes 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.
- Background: PubMed 24595305Areta 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.
- Background: PubMed 24945715Carbone 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.
- Background: PubMed 21177945Wasserman 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.
- Background: PubMed 24307968Gault 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.
- Background: PubMed 25614201Dulloo 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.
- Background: PubMed 8772468Wade 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.
- Background: PubMed 14974441Loucks AB. Energy balance and body composition in sports and exercise. J Sports Sci. 2004 Jan;22(1):1-14. doi: 10.1080/0264041031000140518.
- Background: PubMed 21228564Misra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Koehler, PhD principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction, Protein and Exercise in people with Weight Loss and Starvation, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Metabolic Rate (time frame: Baseline and day 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945410, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.