- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04347447
Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training on Muscle and Tendon Strength in Older Women
Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training Program on Skeletal Muscle and Connective Tissue Strength and Quality in Older Women
Loss of muscle mass and strength is a well-established outcome of normal aging. Muscle strength and mobility are also dependent on the quality and strength of connective tissue, which surrounds skeletal muscle. These layers, which are continuous with tendons, allow for the effective transfer of tension from skeletal muscle to bone to enable movement. Importantly, skeletal muscle strength is directly related to connective tissue strength. Greater tendon connective tissue cross-sectional area and stiffness optimize force transfer through tendon to maximize musculoskeletal function. As with skeletal muscle, tendon connective tissue quality declines with age. Previous research indicates that resistance training can improve muscle strength in older adults, but may not counter the effects of aging on tendon. The specific problem is that no approaches are available that benefit both skeletal muscle and tendon health to minimize loss of muscle mass and quality while also improving connective tissue quality and function in older adults. A critical need exists to assess approaches that improve both muscle and connective tissue strength and function. This need is highly relevant for older women, due to their higher risk of sarcopenia than men.
Resistance training, especially when combined with higher protein intake, has been consistently shown to improve muscle mass and strength in older adults. Further, emerging research indicates that diets rich in total and indispensable amino acids (as in beef) augment exercise-induced improvements in tendon cross-sectional area in rodents and young humans. However, limited research exists on the impact of beef consumption combined with resistance training on muscle and tendon tissue outcomes, especially in older women. This research study will assess the effects of consuming a healthy, protein-rich diet emphasizing lean beef, compared to a healthy, normal-protein, lower beef diet (control 1), and a healthy protein-rich, lower beef diet emphasizing non-beef/red meat protein (control 2) on resistance training-induced changes in muscle and tendon tissue size, strength, and quality in older women.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sarcopenia, i.e., loss of muscle mass and strength, is a well-established consequence of normal aging. Skeletal muscle strength and mobility is also dependent on the composition and mechanical properties of connective tissue, which encase skeletal muscle allowing for effective transfer of tension developed during cross-bridge cycling. Importantly, skeletal muscle strength and function is directly related to connective tissue strength. Specifically, greater tendon connective tissue cross-sectional area (CSA) and stiffness optimize force transfer through tendon to maximize musculoskeletal function, including muscle power output, locomotion economy, and control of balance. As with skeletal muscle, aging leads to the decline of tendon connective tissue quality, including reductions in tendon collagen (the primary structural component of tendon), and a decrease in tendon CSA. Previous research indicates that resistance training (RT) can improve muscle mass and strength in older adults but may not counter the effects of aging on tendon. Specifically, a 12-week RT protocol improved tendon properties in young but not older adults. The specific problem is that no approaches are available that target both skeletal muscle and tendon health to minimize loss of muscle mass and quality while simultaneously improving connective tissue quality and function in older adults. Therefore, a critical need exists to scientifically assess interventions that concomitantly improve muscle and connective tissue strength and function. This need is highly relevant for older women, due to their higher risk of sarcopenia than men.
Resistance training, especially when combined with higher protein intake, has been consistently shown to improve muscle mass and strength in older adults. However, limited research exists on the impact of beef consumption combined with RT on sarcopenia-related outcomes, especially in older women. Further, emerging research indicates that diets rich in leucine or glycine (as in beef) augment resistance or aerobic exercise-induced improvements in tendon CSA in rodents and young humans. However, the potential benefit of lean proteins, such as beef, on connective tissue adaptations in older adults requires investigation. This study will assess the effects of consuming a healthy, protein-rich diet emphasizing lean beef on RT-induced changes in skeletal muscle and tendon connective tissue size, strength, and quality in older women. It is hypothesized that consumption of a healthy diet high in protein from predominately lean beef will augment improvements in both skeletal muscle and tendon responses to RT, when compared to consuming a healthy diet with normal or high-protein and less total red meat. The overall healthy diet will be modeled from the U.S. Healthy Eating Pattern and consistent with the 2015-2020 Dietary Guidelines for Americans.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women 60-80 years old.
- BMI < 40
- Women with HbA1c less than 6.5% (non-diabetic)
- Must be able to complete upper and lower body resistance training exercise
Exclusion Criteria:
- Chronic users of analgesic medications such as acetaminophen, ibuprofen, or prescription cyclooxygenase inhibitors -Prisoners-
- Users of tobacco
- Individuals with claustrophobia or implanted objects who cannot complete on MRI scan
- Individuals with any orthopedic condition that would prevent them from properly performing exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: normal protein diet
The normal protein diet (Control) will contain the RDA for protein of (0.8 g/kg/d), with the protein provided from a variety of animal and plant-based sources, including lean beef (one 3-oz portion per week), chicken, eggs, dairy, beans, grains, nuts, seeds.
|
All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
|
Experimental: a beef protein-rich diet
High protein diet predominantly provided from lean beef (one 3-oz portion per day; total beef intake 24 oz/week).
The energy content of the additional protein foods will be isocalorically offset by substitution for low-protein foods.
|
All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
|
Experimental: a protein-rich diet non-red meat
High-protein group from a variety of animal and plant-based sources (excluding additional red meats).
|
All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal Muscle Mass
Time Frame: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
MRI will be used to determine thigh muscle volume before and after the intervention
|
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Tendon Connective Tissue Stiffness
Time Frame: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Patellar tendon stiffness will be assessed using ultrasound methods
|
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Skeletal Muscle Strength
Time Frame: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Strength will be determined using the 1 repetition maximum method
|
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Patellar Tendon Size
Time Frame: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
MRI will be used to determine tendon cross-sectional area and length
|
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose
Time Frame: 6 and 12 weeks
|
a blood sample will be taken for assessment of blood glucose
|
6 and 12 weeks
|
HbA1c
Time Frame: 6 and 12 weeks
|
a blood sample will be taken for assessment of blood glucose
|
6 and 12 weeks
|
Cholesterol
Time Frame: 6 and 12 weeks
|
a blood sample will be taken for assessment of cholesterol levels
|
6 and 12 weeks
|
Triglycerides
Time Frame: 6 and 12 weeks
|
a blood sample will be taken for assessment of total triglyceride levels
|
6 and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Carroll, PhD, Purdue University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2019-218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Sarcopenia
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on Exercise training
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
Hacettepe UniversityCompleted
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway