Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

Cardiovascular Disease Clinical Trial

Official title:

Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00260442
• Other study ID #: 06-0187
• Secondary ID: 481031-001-CA060
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 29, 2005
• Last updated: November 4, 2015
• Start date: November 2005
• Est. completion date: May 2017

Study information

• Verified date: November 2015
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertrophy
• Sarcopenia

Intervention

Behavioral:
• Resistance Training
12 weeks, 3 times a week whole body resistance training
• Sedentary
Absence of physical activity

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: Strength and muscle gain (DEXA)		after 12 weeks of resistance training	No
Secondary	Secondary: Blood lipids, inflammatory markers, blood pressure		after 12 weeks of resistance training	No