NCT00260442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

November 29, 2005

Last Update Submit

September 23, 2025

Conditions

Keywords

sarcopeniaresistance trainingstrength trainingskeletal muscleelderlycholesterolagingcardiovascular diseasenutritioninflammationlipids

Outcome Measures

Primary Outcomes (1)

  • Primary: Strength and muscle gain (DEXA)

    after 12 weeks of resistance training

Secondary Outcomes (1)

  • Secondary: Blood lipids, inflammatory markers, blood pressure

    after 12 weeks of resistance training

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Behavioral: Resistance TrainingBehavioral: Sedentary

Average intake

EXPERIMENTAL

400 mg/day dietary cholesterol, resistance training, sedentary

Behavioral: Resistance TrainingBehavioral: Sedentary

High intake

EXPERIMENTAL

800 mg/day dietary cholesterol, resistance training, sedentary

Behavioral: Resistance TrainingBehavioral: Sedentary

Interventions

12 weeks, 3 times a week whole body resistance training

Average intakeHigh intakePlacebo
SedentaryBEHAVIORAL

Absence of physical activity

Average intakeHigh intakePlacebo

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women aged 50-69
  • able to perform exercise testing and training

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

SarcopeniaCardiovascular DiseasesInflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven E Riechman, PhD, MPH

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

November 1, 2005

Primary Completion

May 1, 2008

Study Completion

January 1, 2018

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations