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Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults (S25)

This study is currently recruiting participants.
Verified May 2013 by Purdue University
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01396915
First received: February 11, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Muscle Composition and Muscle Size.
Metabolic Health Status.
Muscle Inflammatory Status.
 Dietary Supplement: Dietary Protein Intake

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults [ Time Frame: December 31, 2013 ] [ Designated as safety issue: No ]
    Anticipated subject recruitment completion


Biospecimen Retention:   Samples With DNA

whole blood, serum, and muscle tissue


Estimated Enrollment: 51
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396915

Contacts
Contact: Wayne W Campbell, Ph.D 765.494.8236 campbellw@purdue.edu
Contact: Janet K Green 765.496.6342 jkgreen@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
W. Lafayette, Indiana, United States, 47907
Contact: Wayne W Campbell, Ph.D     765-494-8236     campbell@purdue.edu    
Contact: Janet K Green     765.496.6342     jkgreen@purdue.edu    
Principal Investigator: Wayne W Campbell, Ph.D.            
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D, Purdue University
ClinicalTrials.gov Identifier: NCT01396915     History of Changes
Other Study ID Numbers: 1101010282
Study First Received: February 11, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013