Overview

This trial is active, not recruiting.

Conditions sarcopenia, cardiovascular disease
Treatments resistance training, sedentary
Phase phase 2
Sponsor Texas A&M University
Start date November 2005
End date May 2008
Trial size 36 participants
Trial identifier NCT00260442, 06-0187, 0600083, 481031-001-CA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
< 200 mg/day dietary cholesterol, resistance training, sedentary
resistance training
12 weeks, 3 times a week whole body resistance training
sedentary
Absence of physical activity
(Experimental)
400 mg/day dietary cholesterol, resistance training, sedentary
resistance training
12 weeks, 3 times a week whole body resistance training
sedentary
Absence of physical activity
(Experimental)
800 mg/day dietary cholesterol, resistance training, sedentary
resistance training
12 weeks, 3 times a week whole body resistance training
sedentary
Absence of physical activity

Primary Outcomes

Measure
Primary: Strength and muscle gain (DEXA)
time frame: after 12 weeks of resistance training

Secondary Outcomes

Measure
Secondary: Blood lipids, inflammatory markers, blood pressure
time frame: after 12 weeks of resistance training

Eligibility Criteria

Male or female participants from 50 years up to 69 years old.

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

Additional Information

Official title Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy
Principal investigator Steven E Riechman, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Texas A&M University.