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Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven E.Riechman, Ph.D., M.P.H., Texas A&M University
ClinicalTrials.gov Identifier:
NCT00260442
First received: November 29, 2005
Last updated: November 4, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Sarcopenia
Cardiovascular Disease
Behavioral: Resistance Training
Behavioral: Sedentary
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy

Resource links provided by NLM:


Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • Primary: Strength and muscle gain (DEXA) [ Time Frame: after 12 weeks of resistance training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary: Blood lipids, inflammatory markers, blood pressure [ Time Frame: after 12 weeks of resistance training ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2005
Estimated Study Completion Date: May 2017
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
< 200 mg/day dietary cholesterol, resistance training, sedentary
Behavioral: Resistance Training
12 weeks, 3 times a week whole body resistance training
Behavioral: Sedentary
Absence of physical activity
Experimental: Average intake
400 mg/day dietary cholesterol, resistance training, sedentary
Behavioral: Resistance Training
12 weeks, 3 times a week whole body resistance training
Behavioral: Sedentary
Absence of physical activity
Experimental: High intake
800 mg/day dietary cholesterol, resistance training, sedentary
Behavioral: Resistance Training
12 weeks, 3 times a week whole body resistance training
Behavioral: Sedentary
Absence of physical activity

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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260442

Locations
United States, Texas
Texas A&M University
College Station, Texas, United States, 77843
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Steven E Riechman, PhD, MPH Texas A&M University
  More Information

Responsible Party: Steven E.Riechman, Ph.D., M.P.H., Associate Professor, Texas A&M University
ClinicalTrials.gov Identifier: NCT00260442     History of Changes
Other Study ID Numbers: 06-0187  481031-001-CA  0600083 
Study First Received: November 29, 2005
Last Updated: November 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Texas A&M University:
sarcopenia
resistance training
strength training
skeletal muscle
elderly
cholesterol
aging
cardiovascular disease
nutrition
inflammation
lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertrophy
Sarcopenia
Pathological Conditions, Anatomical
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016