NCT03029975

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

November 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

January 19, 2017

Last Update Submit

November 12, 2019

Conditions

Keywords

beefproteinresistance trainingstrengthperformance

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to the end of the 10 week diet and resistance training intervention

Secondary Outcomes (1)

  • Muscle cross-sectional area

    Change from baseline to the end of the 10 week diet and resistance training intervention

Study Arms (2)

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.

Behavioral: Resistance Training ExerciseBehavioral: 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.

Behavioral: Resistance Training ExerciseBehavioral: Beef Protein Consumption

Interventions

Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.

2x RDARDA

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.

2x RDARDA

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 24, 2017

Study Start

February 1, 2017

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

November 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations