- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613767
Muscle Protein Synthesis Rates After Protein Consumption in Lean, Overweight, and Obese Adults
October 24, 2016 updated by: Nicholas Burd, University of Illinois at Urbana-Champaign
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
32
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Smoking
- Allergies to pork consumption
- Unusually high protein consumption
- Vegetarians
- Phenylketonuria (PKU)
- Diagnosed GI tract diseases
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese
BMI >30 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
Ingestion of protein
experimental method for determining protein synthesis rates
|
Overweight
BMI >25 and < 30 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
Ingestion of protein
experimental method for determining protein synthesis rates
|
Healthy-Weight
BMI >18 and < 25 kg/m2, Protein meal, L-[ring 13C6]Phenylalanine infusion |
Ingestion of protein
experimental method for determining protein synthesis rates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fractional synthetic rate of myofibrillar proteins
Time Frame: 7 hours
|
7 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicholas A Burd, Ph.D, Assistant Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Beals 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
November 5, 2015
First Submitted That Met QC Criteria
November 20, 2015
First Posted (Estimate)
November 24, 2015
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15161 (Other Identifier: City of Hope Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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