ObesityNCT02613767
Muscle Protein Synthesis Rates After Protein Consumption in Lean, Overweight, and Obese Adults
An observational study of Obesity, run by University of Illinois at Urbana-Champaign.
Trial summary
There are an increasing number of individuals in the United States with obesity, and this is a major health concern with links to many chronic diseases. Impairments in protein metabolism with obesity may disrupt muscle function and modify the dietary protein requirements in obese individuals. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Protein meal and L-[ring 13C6]Phenylalanine infusion
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2016
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We recruited 32 healthy, sedentary adult subjects (20-45 y) for this investigation. There are three groups being studied, which will be stratified by body mass index. Because randomization is not possible, groups were balanced by age and sex. No races or ethnic groups will be specifically recruited or excluded.
Who may be able to join
- Males and Females
- Aged between 20-45 years
- Healthy, sedentary
- Three groups, age and sex matched
- Healthy weight group: BMI 18-24.9 kg/m2
- Overweight group: BMI 25-29.9 kg/m2
- Obese group: BMI 30-39.9 kg/m2
Who cannot join
- Smoking
- Allergies to pork consumption
- Unusually high protein consumption
- Vegetarians
- Phenylketonuria (PKU)
- Diagnosed GI tract diseases
Show all 14Show fewer
- Arthritic conditions
- A history of neuromuscular problems
- Previous participation in amino acid tracer studies
- Predisposition to hypertrophic scarring or keloid formation
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Irregular menstrual cycles during the previous year
- Pregnancy
- High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
About this study
There are an increasing number of individuals in the United States with obesity, and this is a major health concern with links to many chronic diseases. Impairments in protein metabolism with obesity may disrupt muscle function and modify the dietary protein requirements in obese individuals. Further, overweight and obese type 2 diabetics exhibit dramatically reduced skeletal muscle mass compared with lean, healthy controls. Surprisingly, the influence of being overweight or obese on this decline in muscle mass remains understudied, despite clear evidence that similar metabolic impairments typically exist in these populations prior to the development of overt diabetes. Protein ingestion provides the amino acid building blocks to synthesize and repair muscle proteins in adults. Previous research has shown that the muscle protein synthetic response to food ingestion may be reduced in overweight/obese adults. However, this research provided the 'free' amino acids in small portions every 15 min during the postprandial period. In free living conditions, however, it is more common to consume protein dense foods in single portions. Currently, there is no information available on how eating protein rich foods affects muscle protein synthesis in overweight and obese adults. This proposed research will fill this research gap by being the first study to compare the muscle protein synthetic response to the ingestion of a meal-like amount of high quality protein in lean, overweight and obese adults. The objective of this study is to determine the muscle protein synthetic response after the consumption of 35g pork protein in lean, overweight and obese adults. In order to assess this objective the researchers propose to use primed continuous infusion of L-[ring-13C6] phenylalanine to measure muscle protein synthesis rates after the consumption of dietary protein. In a parallel design the researchers will study 13 obese (BMI 30-39.9 kg/m2) participants, 13 overweight (BMI 25-29.9 kg/m2), and 13 age-matched lean controls (BMI 18-24.9 kg/m2) between the ages of 20 and 45 years. All subjects will be sedentary and weight stable for the previous 6 months. On the test day, subjects will remain sedentary for the determination of muscle protein synthesis in both the fasted state and after consumption of the protein meal. Blood and muscle sampling will occur on the test day.
Read the detailed description
Participants will be asked to report to the laboratory at 7:00 am following an overnight fast. Upon arrival, a Teflon catheter will be inserted in an antecubital vein of one arm for arterialized blood sampling and a baseline blood sample will be drawn. Arterialized blood samples will be obtained by wrapping the subjects' forearm in a heating blanket (45 °C) for 10 min prior to each blood collection time point. A second Teflon catheter will be inserted in an antecubital vein of the opposite arm, and participants will receive a priming dose of L-[ring- 13C6]phenylalanine (2.0 µmol∙kg) prior to initiating a continuous infusion of L-[ring-13C6]phenylalanine (0.05 µmol∙kg∙min) (t=-240). The prime and continuous tracer infusion will be passed through a 0.2 μm filter. Blood will be collected every 1 hour and biopsies of the vastus lateralis will be collected at t=-180 and t=-15 min using a 5 mm Bergström needle (modified for manual suction) under 2% xylocaine local anesthesia for the measurement of postabsorptive muscle protein synthesis rates. The second biopsy (t=-15 min) will be used to determine baseline levels of phosphorylated and total proteins involved in nutrient sensing and muscle anabolic signaling. Subsequently, the participants will ingest 6 oz of fresh ground center cut pork loin. This cut of meat was selected due to its low lipid content (2.5-3%) and it is uniform in shape, size and composition. Along with the ingested pork, the participants will consume 300 mL of water. The water will be enriched to 5% with tracer according to the phenylalanine content of ~4% in the pork. This approach is required to minimize disturbances in isotopic steady state and provide appropriate conditions for the calculation of postprandial muscle protein synthesis rates. The time required to consume the pork will be recorded. The completion of the pork meal and water will mark the start of the postprandial phase (t=0). During this period, arterialized blood samples will be collected into evacuated chilled heparinized tubes at t=30, 60, 90, 120, 180, 240, and 300 min. Additional muscle biopsies will be collected at t=120 and 300 min of the experimental infusion for the measurement of postprandial muscle protein synthetic and muscle anabolic signaling protein responses. The muscle biopsy samples will be freed from any visible blood, fat, and connective tissue, rapidly frozen in liquid nitrogen and stored at -80˚C until analysis. Blood samples will be centrifuged at 1,000×g at 4˚C for 10 min and separated plasma will be transferred to 2.0 ml cryovials. The plasma samples will be stored at -20˚C until further analysis.
- Conditions
- Obesity
- Being tested
- Protein meal, L-[ring 13C6]Phenylalanine infusion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein mealOther
Ingestion of protein
L-[ring 13C6]Phenylalanine infusionOther
experimental method for determining protein synthesis rates
| Study group | Role | What they receive |
|---|---|---|
| Obese | BMI >30 kg/m2, Protein meal,
L-[ring 13C6]Phenylalanine infusion Receives: Other: Protein meal; Other: L-[ring 13C6]Phenylalanine infusion | |
| Overweight | BMI >25 and < 30 kg/m2, Protein meal,
L-[ring 13C6]Phenylalanine infusion Receives: Other: Protein meal; Other: L-[ring 13C6]Phenylalanine infusion | |
| Healthy-Weight | BMI >18 and < 25 kg/m2, Protein meal,
L-[ring 13C6]Phenylalanine infusion Receives: Other: Protein meal; Other: L-[ring 13C6]Phenylalanine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate of myofibrillar proteins
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Burd, University of Illinois at Urbana-Champaign
- Investigators
- Nicholas A Burd, Ph.D, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613767
- Sponsor's protocol ID
- 15161
- Status last verified
- Oct 2016
- First submitted
- 5 Nov 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beals JW, Mackenzie RWA, van Vliet S, Skinner SK, Pagni BA, Niemiro GM, Ulanov AV, Li Z, Dilger AC, Paluska SA, De Lisio M, Burd NA. Protein-Rich Food Ingestion Stimulates Mitochondrial Protein Synthesis in Sedentary Young Adults of Different BMIs. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3415-3424. doi: 10.1210/jc.2017-00360.
PubMed 28911136Beals JW, Sukiennik RA, Nallabelli J, Emmons RS, van Vliet S, Young JR, Ulanov AV, Li Z, Paluska SA, De Lisio M, Burd NA. Anabolic sensitivity of postprandial muscle protein synthesis to the ingestion of a protein-dense food is reduced in overweight and obese young adults. Am J Clin Nutr. 2016 Oct;104(4):1014-1022. doi: 10.3945/ajcn.116.130385. Epub 2016 Sep 7.
PubMed 27604771
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Protein Synthesis Rates After Protein Consumption in Lean, Overweight, and Obese Adults
- ClinicalTrials.gov ID
- NCT02613767
- Acronym / sponsor ID
- 15161
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Nov 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.
There are an increasing number of individuals in the United States with obesity, and this is a major health concern with links to many chronic diseases. Impairments in protein metabolism with obesity may disrupt muscle function and modify the dietary protein requirements in obese individuals. Further, overweight and obese type 2 diabetics exhibit dramatically reduced skeletal muscle mass compared with lean, healthy controls. Surprisingly, the influence of being overweight or obese on this decline in muscle mass remains understudied, despite clear evidence that similar metabolic impairments typically exist in these populations prior to the development of overt diabetes. Protein ingestion provides the amino acid building blocks to synthesize and repair muscle proteins in adults. Previous research has shown that the muscle protein synthetic response to food ingestion may be reduced in overweight/obese adults. However, this research provided the 'free' amino acids in small portions every 15 min during the postprandial period. In free living conditions, however, it is more common to consume protein dense foods in single portions. Currently, there is no information available on how eating protein rich foods affects muscle protein synthesis in overweight and obese adults. This proposed research will fill this research gap by being the first study to compare the muscle protein synthetic response to the ingestion of a meal-like amount of high quality protein in lean, overweight and obese adults. The objective of this study is to determine the muscle protein synthetic response after the consumption of 35g pork protein in lean, overweight and obese adults. In order to assess this objective the researchers propose to use primed continuous infusion of L-[ring-13C6] phenylalanine to measure muscle protein synthesis rates after the consumption of dietary protein. In a parallel design the researchers will study 13 obese (BMI 30-39.9 kg/m2) participants, 13 overweight (BMI 25-29.9 kg/m2), and 13 age-matched lean controls (BMI 18-24.9 kg/m2) between the ages of 20 and 45 years. All subjects will be sedentary and weight stable for the previous 6 months. On the test day, subjects will remain sedentary for the determination of muscle protein synthesis in both the fasted state and after consumption of the protein meal. Blood and muscle sampling will occur on the test day.
Detailed description
Participants will be asked to report to the laboratory at 7:00 am following an overnight fast. Upon arrival, a Teflon catheter will be inserted in an antecubital vein of one arm for arterialized blood sampling and a baseline blood sample will be drawn. Arterialized blood samples will be obtained by wrapping the subjects' forearm in a heating blanket (45 °C) for 10 min prior to each blood collection time point. A second Teflon catheter will be inserted in an antecubital vein of the opposite arm, and participants will receive a priming dose of L-[ring- 13C6]phenylalanine (2.0 µmol∙kg) prior to initiating a continuous infusion of L-[ring-13C6]phenylalanine (0.05 µmol∙kg∙min) (t=-240). The prime and continuous tracer infusion will be passed through a 0.2 μm filter. Blood will be collected every 1 hour and biopsies of the vastus lateralis will be collected at t=-180 and t=-15 min using a 5 mm Bergström needle (modified for manual suction) under 2% xylocaine local anesthesia for the measurement of postabsorptive muscle protein synthesis rates. The second biopsy (t=-15 min) will be used to determine baseline levels of phosphorylated and total proteins involved in nutrient sensing and muscle anabolic signaling. Subsequently, the participants will ingest 6 oz of fresh ground center cut pork loin. This cut of meat was selected due to its low lipid content (2.5-3%) and it is uniform in shape, size and composition. Along with the ingested pork, the participants will consume 300 mL of water. The water will be enriched to 5% with tracer according to the phenylalanine content of ~4% in the pork. This approach is required to minimize disturbances in isotopic steady state and provide appropriate conditions for the calculation of postprandial muscle protein synthesis rates. The time required to consume the pork will be recorded. The completion of the pork meal and water will mark the start of the postprandial phase (t=0). During this period, arterialized blood samples will be collected into evacuated chilled heparinized tubes at t=30, 60, 90, 120, 180, 240, and 300 min. Additional muscle biopsies will be collected at t=120 and 300 min of the experimental infusion for the measurement of postprandial muscle protein synthetic and muscle anabolic signaling protein responses. The muscle biopsy samples will be freed from any visible blood, fat, and connective tissue, rapidly frozen in liquid nitrogen and stored at -80˚C until analysis. Blood samples will be centrifuged at 1,000×g at 4˚C for 10 min and separated plasma will be transferred to 2.0 ml cryovials. The plasma samples will be stored at -20˚C until further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: Protein meal, Other: L-[ring 13C6]Phenylalanine infusionBMI >30 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
| Overweight | – | Other: Protein meal, Other: L-[ring 13C6]Phenylalanine infusionBMI >25 and < 30 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
| Healthy-Weight | – | Other: Protein meal, Other: L-[ring 13C6]Phenylalanine infusionBMI >18 and < 25 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We recruited 32 healthy, sedentary adult subjects (20-45 y) for this investigation. There are three groups being studied, which will be stratified by body mass index. Because randomization is not possible, groups were balanced by age and sex. No races or ethnic groups will be specifically recruited or excluded.
Key inclusion criteria (7 listed)
- Males and Females
- Aged between 20-45 years
- Healthy, sedentary
- Three groups, age and sex matched
- Healthy weight group: BMI 18-24.9 kg/m2
Key exclusion criteria (14 listed)
- Smoking
- Allergies to pork consumption
- Unusually high protein consumption
- Vegetarians
- Phenylketonuria (PKU)
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 |
|---|---|---|
| Protein mealIngestion of protein | Other | Healthy-Weight, Obese, Overweight |
| L-[ring 13C6]Phenylalanine infusionexperimental method for determining protein synthesis rates | Other | Healthy-Weight, Obese, Overweight |
Primary outcome
Fractional synthetic rate of myofibrillar proteins
Time frame: 7 hours
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 26 Oct 2016.
- Derived from this study: PubMed 28911136Beals JW, Mackenzie RWA, van Vliet S, Skinner SK, Pagni BA, Niemiro GM, Ulanov AV, Li Z, Dilger AC, Paluska SA, De Lisio M, Burd NA. Protein-Rich Food Ingestion Stimulates Mitochondrial Protein Synthesis in Sedentary Young Adults of Different BMIs. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3415-3424. doi: 10.1210/jc.2017-00360.
- Derived from this study: PubMed 27604771Beals JW, Sukiennik RA, Nallabelli J, Emmons RS, van Vliet S, Young JR, Ulanov AV, Li Z, Paluska SA, De Lisio M, Burd NA. Anabolic sensitivity of postprandial muscle protein synthesis to the ingestion of a protein-dense food is reduced in overweight and obese young adults. Am J Clin Nutr. 2016 Oct;104(4):1014-1022. doi: 10.3945/ajcn.116.130385. Epub 2016 Sep 7.
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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.
Nicholas A Burd, Ph.D principal investigator
Assistant Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Illinois at Urbana-Champaign.
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 7 inclusion and 14 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Fractional synthetic rate of myofibrillar proteins (time frame: 7 hours). 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 NCT02613767, which also lists 2 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 26 Oct 2016.