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Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

Primary Purpose

Sarcopenia, Cardiovascular Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Sedentary
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring sarcopenia, resistance training, strength training, skeletal muscle, elderly, cholesterol, aging, cardiovascular disease, nutrition, inflammation, lipids

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: men and women aged 50-69 able to perform exercise testing and training Exclusion Criteria: blood pressure > 160/100 cardiac arrhythmias cancer hernia aortic aneurysm kidney disease lung disease total cholesterol > 240 mg/dl or < 160 mg/dl current use of cholesterol lowering medications actively participating in >1 hour per week of resistance training

Sites / Locations

  • Texas A&M University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Average intake

High intake

Arm Description

< 200 mg/day dietary cholesterol, resistance training, sedentary

400 mg/day dietary cholesterol, resistance training, sedentary

800 mg/day dietary cholesterol, resistance training, sedentary

Outcomes

Primary Outcome Measures

Primary: Strength and muscle gain (DEXA)

Secondary Outcome Measures

Secondary: Blood lipids, inflammatory markers, blood pressure

Full Information

First Posted
November 29, 2005
Last Updated
November 4, 2015
Sponsor
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT00260442
Brief Title
Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy
Official Title
Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine the effect of dietary cholesterol administered as whole egg or egg white (control)on muscle mass gain with resistance training in a young old population of men and women (age 50-69). It is hypothesized that dietary cholesterol will be significantly associated to muscle mass gain.
Detailed Description
The primary objective of this proposal is to have 36 men and women (age 50-69) perform 12 weeks of resistance exercise training for the purpose of inducing skeletal muscle hypertrophy. These individuals will consume either 0, 1, or 3 whole eggs per day in a double-blind design to test the hypothesis that dietary cholesterol is essential for skeletal muscle hypertrophy. If so proven, this will confirm a very strong association between dietary cholesterol and hypertrophy observed in a previous study of 51 men and women (age 60-69). The current proposal is using a randomized double-blind, placebo controlled design to provide the most conclusive evidence that dietary cholesterol plays an essential role in skeletal muscle hypertrophy. The secondary objective of this proposal is to test the hypothesis that increased dietary cholesterol consumption in the context of an exercise program does not alter blood cholesterol concentrations or other cardiovascular risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Cardiovascular Disease
Keywords
sarcopenia, resistance training, strength training, skeletal muscle, elderly, cholesterol, aging, cardiovascular disease, nutrition, inflammation, lipids

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
< 200 mg/day dietary cholesterol, resistance training, sedentary
Arm Title
Average intake
Arm Type
Experimental
Arm Description
400 mg/day dietary cholesterol, resistance training, sedentary
Arm Title
High intake
Arm Type
Experimental
Arm Description
800 mg/day dietary cholesterol, resistance training, sedentary
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
12 weeks, 3 times a week whole body resistance training
Intervention Type
Behavioral
Intervention Name(s)
Sedentary
Intervention Description
Absence of physical activity
Primary Outcome Measure Information:
Title
Primary: Strength and muscle gain (DEXA)
Time Frame
after 12 weeks of resistance training
Secondary Outcome Measure Information:
Title
Secondary: Blood lipids, inflammatory markers, blood pressure
Time Frame
after 12 weeks of resistance training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women aged 50-69 able to perform exercise testing and training Exclusion Criteria: blood pressure > 160/100 cardiac arrhythmias cancer hernia aortic aneurysm kidney disease lung disease total cholesterol > 240 mg/dl or < 160 mg/dl current use of cholesterol lowering medications actively participating in >1 hour per week of resistance training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven E Riechman, PhD, MPH
Organizational Affiliation
Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States

12. IPD Sharing Statement

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Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

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