NCT01396915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 4, 2016

Status Verified

May 1, 2013

Enrollment Period

3 years

First QC Date

February 11, 2011

Last Update Submit

February 2, 2016

Conditions

Keywords

Skeletal muscle lipid contentwhole muscle volumefasting glucoseinsulinblood urea nitrogen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

High or Normal Dietary Protein Intake

Dietary Supplement: Dietary Protein Intake

Interventions

Dietary Protein IntakeDIETARY_SUPPLEMENT

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)

High or Normal Dietary Protein Intake

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and Women between the ages of 65-80

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, and muscle tissue

MeSH Terms

Conditions

SarcopeniaHypertrophyInflammationInsulin Resistance

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic ProcessesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph.D

Study Record Dates

First Submitted

February 11, 2011

First Posted

July 19, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 4, 2016

Record last verified: 2013-05

Locations