SarcopeniaNCT04347447
Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training on Muscle and Tendon Strength in Older Women
A study testing Exercise training in people with Sarcopenia and Aging, run by Purdue University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Aging
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, Aging
- Being tested
- Exercise training
- Keywords
- women, beef, skeletal muscle, tendon, connective tissue, older adults
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
| Study group | Role | What they receive |
|---|---|---|
| normal protein diet | Experimental | 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. Receives: Other: Exercise training |
| a beef protein-rich diet | Experimental | 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. Receives: Other: Exercise training |
| a protein-rich diet non-red meat | Experimental | High-protein group from a variety of animal and plant-based sources (excluding additional red meats). Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Mass
MRI will be used to determine thigh muscle volume before and after the intervention
Measured: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Tendon Connective Tissue Stiffness
Patellar tendon stiffness will be assessed using ultrasound methods
Measured: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Skeletal Muscle Strength
Strength will be determined using the 1 repetition maximum method
Measured: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Patellar Tendon Size
MRI will be used to determine tendon cross-sectional area and length
Measured: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Secondary outcomes (4)
Blood glucose
a blood sample will be taken for assessment of blood glucose
Measured: 6 and 12 weeks
HbA1c
a blood sample will be taken for assessment of blood glucose
Measured: 6 and 12 weeks
Cholesterol
a blood sample will be taken for assessment of cholesterol levels
Measured: 6 and 12 weeks
Triglycerides
a blood sample will be taken for assessment of total triglyceride levels
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 May 2020
- Primary completion20 Dec 2022
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three intervention groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Principal investigator, Chad C. Carroll, Purdue University
- Investigators
- Chad Carroll, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347447
- Sponsor's protocol ID
- IRB-2019-218
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2020
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroll CC, Campbell NW, Lewis RL, Preston SE, Garrett CM, Winstone HM, Barker AC, Vanos JM, Stouder LS, Reyes C, Fortino MA, Goergen CJ, Hass ZJ, Campbell WW. Greater Protein Intake Emphasizing Lean Beef Does Not Affect Resistance Training-Induced Adaptations in Skeletal Muscle and Tendon of Older Women: A Randomized Controlled Feeding Trial. J Nutr. 2024 Jun;154(6):1803-1814. doi: 10.1016/j.tjnut.2024.04.001. Epub 2024 Apr 9.
PubMed 38604504
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04347447
- Acronym / sponsor ID
- IRB-2019-218
- Conditions
- Sarcopenia, Aging
- Keywords
- women, beef, skeletal muscle, tendon, connective tissue, older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- three intervention groups
| Arm | Type | Receives |
|---|---|---|
| normal protein diet | Experimental | Other: Exercise trainingThe 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. |
| a beef protein-rich diet | Experimental | Other: Exercise trainingHigh 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. |
| a protein-rich diet non-red meat | Experimental | Other: Exercise trainingHigh-protein group from a variety of animal and plant-based sources (excluding additional red meats). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAll groups will complete a supervised 12-week resistance training protocol, 3 days per week. | Other | a beef protein-rich diet, a protein-rich diet non-red meat, normal protein diet |
Primary outcome
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
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
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
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
4 secondary outcomes
Blood glucose
Time frame: 6 and 12 weeks
HbA1c
Time frame: 6 and 12 weeks
Cholesterol
Time frame: 6 and 12 weeks
Triglycerides
Time frame: 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 38604504Carroll CC, Campbell NW, Lewis RL, Preston SE, Garrett CM, Winstone HM, Barker AC, Vanos JM, Stouder LS, Reyes C, Fortino MA, Goergen CJ, Hass ZJ, Campbell WW. Greater Protein Intake Emphasizing Lean Beef Does Not Affect Resistance Training-Induced Adaptations in Skeletal Muscle and Tendon of Older Women: A Randomized Controlled Feeding Trial. J Nutr. 2024 Jun;154(6):1803-1814. doi: 10.1016/j.tjnut.2024.04.001. Epub 2024 Apr 9.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Carroll, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Sarcopenia and Aging, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Mass (time frame: within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.