- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029975
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
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.
|
Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
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
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
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.
Collaborators
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.
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)
February 1, 2017
Primary Completion (ACTUAL)
May 17, 2019
Study Completion (ACTUAL)
May 17, 2019
Study Registration Dates
First Submitted
January 19, 2017
First Submitted That Met QC Criteria
January 23, 2017
First Posted (ESTIMATE)
January 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 13, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID 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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