AgingNCT03029975
The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults
A study testing Resistance Training Exercise and Beef Protein Consumption in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistance Training Exercise and Beef Protein Consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 17 May 2019
- 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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-obese adults: BMI <30 kg/m2
- Aged between 40-64 years
- Sedentary
- Weight-stable for 6 months prior
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aging
- Being tested
- Resistance Training Exercise, Beef Protein Consumption
- Keywords
- beef, protein, resistance training, strength, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training ExerciseBehavioural
Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
Beef Protein ConsumptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RDA | Active comparator | 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. Receives: Behavioral: Resistance Training Exercise; Behavioral: Beef Protein Consumption |
| 2x RDA | Experimental | 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. Receives: Behavioral: Resistance Training Exercise; Behavioral: Beef Protein Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal strength of leg muscles
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.
Measured: Change from baseline to the end of the 10 week diet and resistance training intervention
Secondary outcomes (1)
Muscle cross-sectional area
Using muscle biopsies, the investigators will assess the muscle cross sectional area of the vastus lateralis pre and post intervention.
Measured: Change from baseline to the end of the 10 week diet and resistance training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion17 May 2019
- Study completion17 May 2019
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 AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will consist of two groups: one group will be asked to consume 2x the RDA of protein during the 10 week intervention, while the other group will be asked to consume the RDA for protein. Both groups will receive 10 weeks of the same resistance training intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029975
- Sponsor's protocol ID
- 16997
- Status last verified
- Aug 2019
- First submitted
- 19 Jan 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKenna CF, Salvador AF, Hughes RL, Scaroni SE, Alamilla RA, Askow AT, Paluska SA, Dilger AC, Holscher HD, De Lisio M, Khan NA, Burd NA. Higher protein intake during resistance training does not potentiate strength, but modulates gut microbiota, in middle-aged adults: a randomized control trial. Am J Physiol Endocrinol Metab. 2021 May 1;320(5):E900-E913. doi: 10.1152/ajpendo.00574.2020. Epub 2021 Mar 8.
PubMed 33682457
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT03029975
- Acronym / sponsor ID
- 16997
- Conditions
- Aging
- Keywords
- beef, protein, resistance training, strength, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will consist of two groups: one group will be asked to consume 2x the RDA of protein during the 10 week intervention, while the other group will be asked to consume the RDA for protein. Both groups will receive 10 weeks of the same resistance training intervention.
| Arm | Type | Receives |
|---|---|---|
| RDA | Active comparator | Behavioral: Resistance Training Exercise, Behavioral: Beef Protein ConsumptionParticipants 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. |
| 2x RDA | Experimental | Behavioral: Resistance Training Exercise, Behavioral: Beef Protein ConsumptionParticipants 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-obese adults: BMI <30 kg/m2
- Aged between 40-64 years
- Sedentary
- Weight-stable for 6 months prior
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Resistance Training ExerciseParticipants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention. | Behavioural | 2x RDA, RDA |
| Beef Protein ConsumptionFollowing 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. | Behavioural | 2x RDA, RDA |
Primary outcome
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.
1 secondary outcome
Muscle cross-sectional area
Time frame: Change from baseline to the end of the 10 week diet and resistance training intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 33682457McKenna CF, Salvador AF, Hughes RL, Scaroni SE, Alamilla RA, Askow AT, Paluska SA, Dilger AC, Holscher HD, De Lisio M, Khan NA, Burd NA. Higher protein intake during resistance training does not potentiate strength, but modulates gut microbiota, in middle-aged adults: a randomized control trial. Am J Physiol Endocrinol Metab. 2021 May 1;320(5):E900-E913. doi: 10.1152/ajpendo.00574.2020. Epub 2021 Mar 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Exercise and Beef Protein Consumption in people with Aging, run by University of Illinois at Urbana-Champaign 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 17 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: finished, as of the sponsor's last update on 13 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal strength of leg muscles (time frame: Change from baseline to the end of the 10 week diet and resistance training intervention). 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 NCT03029975, 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 13 Nov 2019.