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Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training on Muscle and Tendon Strength in Older Women

Primary Purpose

Sarcopenia, Aging

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring women, beef, skeletal muscle, tendon, connective tissue, older adults

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

normal protein diet

a beef protein-rich diet

a protein-rich diet non-red meat

Arm Description

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.

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.

High-protein group from a variety of animal and plant-based sources (excluding additional red meats).

Outcomes

Primary Outcome Measures

Skeletal Muscle Mass
MRI will be used to determine thigh muscle volume before and after the intervention
Tendon Connective Tissue Stiffness
Patellar tendon stiffness will be assessed using ultrasound methods
Skeletal Muscle Strength
Strength will be determined using the 1 repetition maximum method
Patellar Tendon Size
MRI will be used to determine tendon cross-sectional area and length

Secondary Outcome Measures

Blood glucose
a blood sample will be taken for assessment of blood glucose
HbA1c
a blood sample will be taken for assessment of blood glucose
Cholesterol
a blood sample will be taken for assessment of cholesterol levels
Triglycerides
a blood sample will be taken for assessment of total triglyceride levels

Full Information

First Posted
March 31, 2020
Last Updated
August 28, 2023
Sponsor
Purdue University
Collaborators
National Cattlemen's Beef Association
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1. Study Identification

Unique Protocol Identification Number
NCT04347447
Brief Title
Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training on Muscle and Tendon Strength in Older Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
National Cattlemen's Beef Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aging
Keywords
women, beef, skeletal muscle, tendon, connective tissue, older adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three intervention groups
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal protein diet
Arm Type
Experimental
Arm Description
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.
Arm Title
a beef protein-rich diet
Arm Type
Experimental
Arm Description
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.
Arm Title
a protein-rich diet non-red meat
Arm Type
Experimental
Arm Description
High-protein group from a variety of animal and plant-based sources (excluding additional red meats).
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
Primary Outcome Measure Information:
Title
Skeletal Muscle Mass
Description
MRI will be used to determine thigh muscle volume before and after the intervention
Time Frame
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Title
Tendon Connective Tissue Stiffness
Description
Patellar tendon stiffness will be assessed using ultrasound methods
Time Frame
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Title
Skeletal Muscle Strength
Description
Strength will be determined using the 1 repetition maximum method
Time Frame
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Title
Patellar Tendon Size
Description
MRI will be used to determine tendon cross-sectional area and length
Time Frame
within 1 week prior to beginning the intervention and then again within 1 week of completing the intervention
Secondary Outcome Measure Information:
Title
Blood glucose
Description
a blood sample will be taken for assessment of blood glucose
Time Frame
6 and 12 weeks
Title
HbA1c
Description
a blood sample will be taken for assessment of blood glucose
Time Frame
6 and 12 weeks
Title
Cholesterol
Description
a blood sample will be taken for assessment of cholesterol levels
Time Frame
6 and 12 weeks
Title
Triglycerides
Description
a blood sample will be taken for assessment of total triglyceride levels
Time Frame
6 and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Carroll, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Incorporating Lean Beef Into a Protein-rich Diet During Resistance Training on Muscle and Tendon Strength in Older Women

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