- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260442
Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843
- Texas A&M University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
< 200 mg/day dietary cholesterol, resistance training, sedentary
|
12 weeks, 3 times a week whole body resistance training
Absence of physical activity
|
|
Experimental: Average intake
400 mg/day dietary cholesterol, resistance training, sedentary
|
12 weeks, 3 times a week whole body resistance training
Absence of physical activity
|
|
Experimental: High intake
800 mg/day dietary cholesterol, resistance training, sedentary
|
12 weeks, 3 times a week whole body resistance training
Absence of physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary: Strength and muscle gain (DEXA)
Time Frame: after 12 weeks of resistance training
|
after 12 weeks of resistance training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Secondary: Blood lipids, inflammatory markers, blood pressure
Time Frame: after 12 weeks of resistance training
|
after 12 weeks of resistance training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven E Riechman, PhD, MPH, Texas A&M University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cardiovascular Diseases
- Inflammation
- Sarcopenia
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 06-0187
- 481031-001-CA
- 0600083
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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