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Effects of Increased, Egg-Based Protein Intake on Muscle Composition, (S25)

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ClinicalTrials.gov Identifier: NCT01396915
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.

Condition or disease Intervention/treatment
Muscle Composition Sarcopenia Hypertrophy Inflammation Dietary Supplement: Dietary Protein Intake

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Study Start Date : February 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Proteins
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
High or Normal Dietary Protein Intake Dietary Supplement: Dietary Protein Intake
Dietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1)


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults [ Time Frame: December 31, 2013 ]
    Anticipated subject recruitment completion


Biospecimen Retention:   Samples With DNA
whole blood, serum, and muscle tissue

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and Women between the ages of 65-80
Criteria

Inclusion Criteria:

  • Men and Women between the ages of 55-80
  • Body Mass Index between 27-35
  • Non Diabetic
  • Normal liver, kidney and heart functions within 10% of clinical normalcy
  • Not currently following a weight loss or other special /non balanced diets
  • weight stable

Exclusion Criteria:

  • fasting glucose > 110 mg/dl
  • blood pressure > 160/110 mm Hg
  • plasma total cholesterol > 260 mg/dl
  • LDL-cholesterol >160mg/dl
  • triacylglycerol>400 mg/dl
  • >than 1 hour/week of habitual aerobic and /or resistance exercise
  • Currently taking prescribed blood thinners
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396915


Locations
United States, Indiana
Purdue University
W. Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D, Purdue University
ClinicalTrials.gov Identifier: NCT01396915     History of Changes
Other Study ID Numbers: 1101010282
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: May 2013

Keywords provided by Wayne Campbell, Purdue University:
Skeletal muscle lipid content
whole muscle volume
fasting glucose
insulin
blood urea nitrogen

Additional relevant MeSH terms:
Inflammation
Sarcopenia
Hypertrophy
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms