Effects of Increased, Egg-Based Protein Intake on Muscle... | NCT01396915

Studies
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,

NCT01396915

Sponsor

Purdue University

Status

Completed

Last Update Posted

Feb 4, 2016Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Muscle Composition
Sarcopenia
Hypertrophy
Inflammation

Interventions

Dietary Protein Intake

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 11, 2011

First Submission Date that Met QC Criteria

Jul 15, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2016

Last Update Posted Date

Feb 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High or Normal Dietary Protein Intake			Dietary Supplement: Dietary Protein Intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Protein Intake	Dietary 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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Men and Women between the ages of 65-80

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wayne W Campbell, Ph.D.	Purdue University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University		West Lafayette	Indiana	47907	United States

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia
D006984	Hypertrophy
D007249	Inflammation
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided