NCT04347447

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 31, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

2.6 years

First QC Date

March 31, 2020

Last Update Submit

August 28, 2023

Conditions

Keywords

womenbeefskeletal muscletendonconnective tissueolder adults

Outcome Measures

Primary Outcomes (4)

  • Skeletal Muscle Mass

    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

    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

    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

    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 Outcomes (4)

  • Blood glucose

    6 and 12 weeks

  • HbA1c

    6 and 12 weeks

  • Cholesterol

    6 and 12 weeks

  • Triglycerides

    6 and 12 weeks

Study Arms (3)

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.

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.

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).

Other: Exercise training

Interventions

All groups will complete a supervised 12-week resistance training protocol, 3 days per week.

a beef protein-rich dieta protein-rich diet non-red meatnormal protein diet

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chad Carroll, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: three intervention groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor,Health and Kinesiology

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 15, 2020

Study Start

May 1, 2020

Primary Completion

December 20, 2022

Study Completion

December 1, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations