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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01396915
Other study ID # 1101010282
Secondary ID
Status Completed
Phase N/A
First received February 11, 2011
Last updated February 2, 2016
Start date February 2011
Est. completion date February 2014

Study information

Verified date May 2013
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States Purdue University W. Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults Anticipated subject recruitment completion December 31, 2013 No
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