NCT02613767

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

November 5, 2015

Last Update Submit

October 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fractional synthetic rate of myofibrillar proteins

    7 hours

Study Arms (3)

Obese

BMI \>30 kg/m2, Protein meal, L-\[ring 13C6\]Phenylalanine infusion

Other: Protein mealOther: L-[ring 13C6]Phenylalanine infusion

Overweight

BMI \>25 and \< 30 kg/m2, Protein meal, L-\[ring 13C6\]Phenylalanine infusion

Other: Protein mealOther: L-[ring 13C6]Phenylalanine infusion

Healthy-Weight

BMI \>18 and \< 25 kg/m2, Protein meal, L-\[ring 13C6\]Phenylalanine infusion

Other: Protein mealOther: L-[ring 13C6]Phenylalanine infusion

Interventions

Ingestion of protein

Healthy-WeightObeseOverweight

experimental method for determining protein synthesis rates

Healthy-WeightObeseOverweight

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples and Skeletal muscle tissue

MeSH Terms

Conditions

Obesity

Interventions

guar meal protein, Cyamopsis tetragonoloba

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas A Burd, Ph.D

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 24, 2015

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

August 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10