- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01396915
Effects of Increased, Egg-Based Protein Intake on Muscle Composition, (S25)
February 2, 2016 updated by: Wayne Campbell, Purdue University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
W. Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Men and Women between the ages of 65-80
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High or Normal 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
December 31, 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
February 11, 2011
First Submitted That Met QC Criteria
July 15, 2011
First Posted (Estimate)
July 19, 2011
Study Record Updates
Last Update Posted (Estimate)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1101010282
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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