ObesityNCT02406040
Effects of Short-term Energy Deficit on Muscle Protein Turnover
A study testing Energy Restriction in people with Obesity, run by McMaster University at 1 site in Canada.
Trial summary
Weight loss through energy restriction results in the loss of both fat and muscle mass. Muscle mass is important for mobility, strength, glucose control and energy expenditure, and therefore the retention of muscle mass during energy restriction is an important goal. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Energy Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 20 and 30 years inclusive
- Have a BMI between 25 and 33 inclusive
Who cannot join
- Have a body mass index less than 25 kg/m2 or greater than 33 kg/m2.
- Vegan
- History of allergy, sensitivity, or strong dislike towards dairy protein
- Smoker or user of tobacco products
- High physical activity
- Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which volunteers are being treated that might put them at risk for this study.
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- Taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications
- Use of an investigational drug product within the last 30 days
- Have participated in an infusion protocol in the last year
- Do not understand English or have a condition the PI believes would interfere with the ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put volunteers at undue risk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Weight loss through energy restriction results in the loss of both fat and muscle mass. Muscle mass is important for mobility, strength, glucose control and energy expenditure, and therefore the retention of muscle mass during energy restriction is an important goal. The retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and muscle protein breakdown (MPB). It is well known that MPS is reduced during weight loss, however the effect of weight loss on MPB is currently a topic of debate. The purpose of this study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy restriction. In addition, the effect of resistance exercise and protein (both known to preserve muscle mass) on MPS and MPB will be examined
Read the detailed description
An undesirable consequence of energy restriction is the loss of muscle mass. Muscle mass is determined by the the rates of two processes: muscle protein synthesis and muscle protein breakdown. It has been consistently shown that a reduced rate of muscle protein synthesis exists during energy restriction. However, it is currently unclear whether an increase in muscle protein breakdown also contributes to muscle mass loss. In addition, the effect of high protein diets and resistance exercise on muscle protein turnover during energy restriction, two interventions known to preserve muscle, remains to be investigated.We aim to demonstrate that the decrease in muscle protein synthesis is the main contributor to a negative protein balance during energy restriction. In addition, we hope to show that a higher-protein diet (2.4g/kg/d versus 1.2g/kg/d) and the addition of resistance exercise can help to maintain the muscle protein synthesis rate and thereby improve negative protein balance.The present study will be designed as a parallel group randomized controlled trial. Subjects will be given pre-packaged diets (Copper County Foods) to consume which will put them in a relative energy deficit of 40% per day. Based on random assignment, these subjects will either consume an adequate protein diet (1.2g/kg/d) or a high protein diet (2.4g/kg/d) for 10 consecutive days. Participants in the adequate protein diet will consume a ratio of 50:35:15 (carbohydrates:fat:protein) while subjects within the high protein diet will consume a ratio of 50:15:35 (carbohydrates:fat:protein). Subjects will undergo testing at baseline and following a 10 day dietary and unilateral resistance exercise intervention. Testing will consist of muscle and blood samples. Muscle protein synthesis and muscle protein breakdown will be measured using stable isotope tracers that are orally ingested (deuterated water) or infused into an antecubital vein (labelled phenylalanine tracers) before and after the 10 day diet.
- Conditions
- Obesity
- Being tested
- Energy Restriction
- Keywords
- Protein synthesis, Protein breakdown, Muscle, Energy restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy RestrictionOther
All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements. In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
| Study group | Role | What they receive |
|---|---|---|
| High Protein | Experimental | 2.4g protein/kg/d. The macronutrient composition will be 50:15:35 (carbohydrates:fat:protein) during Energy Restriction Receives: Other: Energy Restriction |
| Adequate Protein | Experimental | 1.2g protein/kg/d. The macronutrient composition will be 50:35:15 (carbohydrates:fat:protein) during Energy Restriction Receives: Other: Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein turnover
Change in muscle protein synthesis and muscle protein breakdown before and after the weight loss diet will be assessed. The relationship between high protein diets (parallel groups) and exercise (unilateral resistance exercise) on muscle protein turnover will also be examined. Muscle protein synthesis and muscle protein breakdown will be measured with stable isotope infusions of labelled phenylalanine tracers before and after the 10 day diet. In addition, long term muscle protein synthesis will be measured with orally ingested deuterated water.
Measured: Baseline and 10 days
Secondary outcomes (1)
Molecular markers
Change in the the transcriptional expression of genes involved in the ubiquitin-proteasome pathway (main regulator of muscle protein breakdown) measured in muscle samples obtained at baseline and following the 10 day dietary intervention by quantitative polymerase chain reaction (qPCR). These same samples will be analyzed by western blot for the expression of active and inactive isoforms of caspase-3, an important component of muscle protein breakdown. Finally, immunoprecipitation and western blot will be used to examine the ubiquitination of translation initiation factors at baseline and following the 10 day intervention
Measured: Baseline and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart M. Phillips, McMaster University
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406040
- Sponsor's protocol ID
- not assigned
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
PubMed 23739654Pasiakos SM, Vislocky LM, Carbone JW, Altieri N, Konopelski K, Freake HC, Anderson JM, Ferrando AA, Wolfe RR, Rodriguez NR. Acute energy deprivation affects skeletal muscle protein synthesis and associated intracellular signaling proteins in physically active adults. J Nutr. 2010 Apr;140(4):745-51. doi: 10.3945/jn.109.118372. Epub 2010 Feb 17.
PubMed 20164371Areta 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 24595305Hector AJ, Marcotte GR, Churchward-Venne TA, Murphy CH, Breen L, von Allmen M, Baker SK, Phillips SM. Whey protein supplementation preserves postprandial myofibrillar protein synthesis during short-term energy restriction in overweight and obese adults. J Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17.
PubMed 25644344
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Energy Deficit on Muscle Protein Turnover
- ClinicalTrials.gov ID
- NCT02406040
- Acronym / sponsor ID
- not assigned
- Conditions
- Obesity
- Keywords
- Protein synthesis, Protein breakdown, Muscle, Energy restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weight loss through energy restriction results in the loss of both fat and muscle mass. Muscle mass is important for mobility, strength, glucose control and energy expenditure, and therefore the retention of muscle mass during energy restriction is an important goal. The retention of muscle mass depends on the balance between muscle protein synthesis (MPS) and muscle protein breakdown (MPB). It is well known that MPS is reduced during weight loss, however the effect of weight loss on MPB is currently a topic of debate. The purpose of this study is to assess the effect of short-term (10 day) weight loss (40% energy deficit) on both MPS and MPB in order to gain insight into the mechanisms causing muscle loss during energy restriction. In addition, the effect of resistance exercise and protein (both known to preserve muscle mass) on MPS and MPB will be examined
Detailed description
An undesirable consequence of energy restriction is the loss of muscle mass. Muscle mass is determined by the the rates of two processes: muscle protein synthesis and muscle protein breakdown. It has been consistently shown that a reduced rate of muscle protein synthesis exists during energy restriction. However, it is currently unclear whether an increase in muscle protein breakdown also contributes to muscle mass loss. In addition, the effect of high protein diets and resistance exercise on muscle protein turnover during energy restriction, two interventions known to preserve muscle, remains to be investigated.We aim to demonstrate that the decrease in muscle protein synthesis is the main contributor to a negative protein balance during energy restriction. In addition, we hope to show that a higher-protein diet (2.4g/kg/d versus 1.2g/kg/d) and the addition of resistance exercise can help to maintain the muscle protein synthesis rate and thereby improve negative protein balance.The present study will be designed as a parallel group randomized controlled trial. Subjects will be given pre-packaged diets (Copper County Foods) to consume which will put them in a relative energy deficit of 40% per day. Based on random assignment, these subjects will either consume an adequate protein diet (1.2g/kg/d) or a high protein diet (2.4g/kg/d) for 10 consecutive days. Participants in the adequate protein diet will consume a ratio of 50:35:15 (carbohydrates:fat:protein) while subjects within the high protein diet will consume a ratio of 50:15:35 (carbohydrates:fat:protein). Subjects will undergo testing at baseline and following a 10 day dietary and unilateral resistance exercise intervention. Testing will consist of muscle and blood samples. Muscle protein synthesis and muscle protein breakdown will be measured using stable isotope tracers that are orally ingested (deuterated water) or infused into an antecubital vein (labelled phenylalanine tracers) before and after the 10 day diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein | Experimental | Other: Energy Restriction2.4g protein/kg/d. The macronutrient composition will be 50:15:35 (carbohydrates:fat:protein) during Energy Restriction |
| Adequate Protein | Experimental | Other: Energy Restriction1.2g protein/kg/d. The macronutrient composition will be 50:35:15 (carbohydrates:fat:protein) during Energy Restriction |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 20 and 30 years inclusive
- Have a BMI between 25 and 33 inclusive
Key exclusion criteria (10 listed)
- Have a body mass index less than 25 kg/m2 or greater than 33 kg/m2.
- Vegan
- History of allergy, sensitivity, or strong dislike towards dairy protein
- Smoker or user of tobacco products
- High physical activity
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 |
|---|---|---|
| Energy RestrictionAll meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements. In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit. | Other | Adequate Protein, High Protein |
Primary outcome
Muscle protein turnover
Time frame: Baseline and 10 days
Change in muscle protein synthesis and muscle protein breakdown before and after the weight loss diet will be assessed. The relationship between high protein diets (parallel groups) and exercise (unilateral resistance exercise) on muscle protein turnover will also be examined. Muscle protein synthesis and muscle protein breakdown will be measured with stable isotope infusions of labelled phenylalanine tracers before and after the 10 day diet. In addition, long term muscle protein synthesis will be measured with orally ingested deuterated water.
1 secondary outcome
Molecular markers
Time frame: Baseline and 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 23739654Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
- Background: PubMed 20164371Pasiakos SM, Vislocky LM, Carbone JW, Altieri N, Konopelski K, Freake HC, Anderson JM, Ferrando AA, Wolfe RR, Rodriguez NR. Acute energy deprivation affects skeletal muscle protein synthesis and associated intracellular signaling proteins in physically active adults. J Nutr. 2010 Apr;140(4):745-51. doi: 10.3945/jn.109.118372. Epub 2010 Feb 17.
- 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 25644344Hector AJ, Marcotte GR, Churchward-Venne TA, Murphy CH, Breen L, von Allmen M, Baker SK, Phillips SM. Whey protein supplementation preserves postprandial myofibrillar protein synthesis during short-term energy restriction in overweight and obese adults. J Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17.
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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.
Stuart M Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Restriction in people with Obesity, run by McMaster University at 1 site in Canada.
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 2 inclusion and 10 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 16 Mar 2016. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle protein turnover (time frame: Baseline and 10 days). 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 NCT02406040, which also lists 4 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 16 Mar 2016.