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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wayne Campbell, Purdue University

ClinicalTrials.gov Identifier:

NCT01396915

First received: February 11, 2011

Last updated: February 2, 2016

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 Sarcopenia Hypertrophy Inflammation	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,

Resource links provided by NLM:

MedlinePlus related topics: Dietary Proteins

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


Enrollment:	22
Study Start Date:	February 2011
Study Completion Date:	February 2014
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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:	February 2, 2016
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 Hypertrophy Sarcopenia Pathologic Processes Pathological Conditions, Anatomical Muscular Atrophy	Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Atrophy Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016

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