NCT03411681

Brief Summary

Obesity has numerous comorbidities that are associated with exceedingly high healthcare costs. In addition to well- characterized impairments in lipid and glucose metabolism, obesity is associated with altered protein metabolism. We have recently observed that obese individuals are essentially nonresponsive to protein ingestion with respect to myofibrillar protein synthesis. This suggests that skeletal muscle remodeling in obese individuals is impaired possibly contributing to a poor metabolic quality of muscle. Resistance exercise is known to strongly augment muscle protein synthesis in response to protein ingestion. The purpose of this research is to determine the muscle protein synthetic response during post-exercise recovery in obese individuals. Using stable isotope methodology, we will determine the postprandial muscle protein synthetic response in 14 male and female obese adults (Age: 20-45, BMI: 30-39.9 kg/m2) immediately after an acute bout of resistance exercise. Participants will be sedentary (\< 60 min exercise/ week) and weight stable for a minimum of 6 months. During the testing blood and muscle samples will be collected. In addition participants will be asked to perform moderate intensity resistance exercise. Completion of the proposed research will identify the role of resistance exercise in the maintenance of skeletal muscle tissue after the consumption of a protein-dense meal in obese people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

December 12, 2017

Last Update Submit

April 30, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar protein synthesis

    Fractional synthesis rate of myofibrillar proteins

    change over a 300 minute postprandial period

Study Arms (2)

Normal Weight

ACTIVE COMPARATOR
Other: Resistance Exercise

Obese

EXPERIMENTAL
Other: Resistance Exercise

Interventions

Resistance ExerciseOTHER

Participants will perform 4 sets of 12 repetitions of moderate intensity leg extension

Normal WeightObese

Eligibility Criteria

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

You may qualify if:

  • Healthy-weight adults: BMI 18-24.9 kg/m2
  • Obese adults: BMI 30-39.9 kg/m2
  • Aged between 20-45 years
  • Healthy
  • Sedentary

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 obese (e.g. resistance trained individuals, football players)
  • Contraindications for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

January 26, 2018

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

May 1, 2018

Last Updated

May 1, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)