The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults

November 12, 2019 updated by: University of Illinois at Urbana-Champaign
Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in cognitive function. It is not quite clear why this happens; however, it is known that the loss of muscle and strength can increase risk for physical and mental health risks and impair the ability of older people to remain physically independent. Weight lifting and proper nutrition, particularly eating high quality protein at the proper time and quantity, may help prevent these losses when a person gets older. To determine if regular beef consumption as part of a higher protein diet aids the muscle adaptive response to resistance training and improvements in cognition, seventy healthy individuals will be recruited to lift weights 3 times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College of Sports Medicine. Participants will have their muscle strength tested and samples of blood and muscles will be collected before and after training to determine how the muscle adaptive response to resistance exercise is affected by higher protein intake. In addition, participants will undergo cognitive assessments at baseline and follow-up to determine the influence of improving muscle strength on attention and memory. Overall, the investigators proposed study will use sensitive methodology to determine if providing protein above the RDA and at optimal times during the day in combination with a weight lifting program can help make someone stronger and build larger muscles than someone consuming the RDA, as well as what processes may be responsible for helping the muscles to get bigger and stronger.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Freer Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-obese adults: BMI <30 kg/m2
  • Aged between 40-64 years
  • Sedentary
  • Weight-stable for 6 months prior

Exclusion Criteria:

  • Allergies to beef consumption
  • Phenylketonuria (PKU)
  • BMI >30 kg/m2
  • history of active cardiovascular disease, diabetes mellitus, GI disorders, musculoskeletal/orthopedic disorders (e.g. osteoarthritis, rheumatoid arthritis, tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)
  • hypersensitivity or allergy to antibiotics
  • Kidney, urinary, or liver conditions
  • Epilepsy
  • Diagnosed mental illness
  • have bleeding or clotting disorders (or take related medications e.g.. Coumadin/ low dose Aspirin)
  • High alcohol consumption
  • use tobacco
  • uncontrolled hypertension
  • vegan/vegetarian diets
  • on medications known to affect protein metabolism (i.e. corticosteroids, androgen/estrogen containing compounds, non-steroidal anti-inflammatories)
  • habitual consumption of high (>1.8 g protein/kg/d) or low (<0.66 g protein/kg/day)
  • pregnancy
  • supplements that influence protein metabolism (e.g. omega 3 fish oils)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: RDA
Participants will be asked to consume the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein consumption will be emphasized and participants will consume a beef meal after each training session.
Behavioral: Resistance Training Exercise
Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
Behavioral: Beef Protein Consumption
Following each resistance training sessions, participants will consume either a 3oz or 6oz beef patty (corresponding to the randomly assigned nutritional intervention group). Participants will also be provided with beef protein powder and beef snack bars to help them achieve their assigned protein goals during the intervention period.
EXPERIMENTAL: 2x RDA
Participants will be asked to consume the twice the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein will be emphasized and participants will consume a beef meal after each training session.
Behavioral: Resistance Training Exercise
Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
Behavioral: Beef Protein Consumption
Following each resistance training sessions, participants will consume either a 3oz or 6oz beef patty (corresponding to the randomly assigned nutritional intervention group). Participants will also be provided with beef protein powder and beef snack bars to help them achieve their assigned protein goals during the intervention period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal strength of leg muscles
Time Frame: Change from baseline to the end of the 10 week diet and resistance training intervention
Assess maximum strength of legs using an isokinetic dynamometer in combination with 1 repetition maximum testing on leg extension, leg press, and leg curl machines.
Change from baseline to the end of the 10 week diet and resistance training intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle cross-sectional area
Time Frame: Change from baseline to the end of the 10 week diet and resistance training intervention
Using muscle biopsies, the investigators will assess the muscle cross sectional area of the vastus lateralis pre and post intervention.
Change from baseline to the end of the 10 week diet and resistance training intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cattlemen's Beef Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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