- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876299
The Anabolic Properties of a Lipid-rich Pork Matrix
August 24, 2023 updated by: University of Illinois at Urbana-Champaign
The amount and quality of skeletal muscle mass determines physical performance, but also a significant contributor to metabolic health.
As such, the maintenance of skeletal muscle mass is relevant across the lifespan to remain active in family and community life.
Food ingestion, particularly protein, is one of the main anabolic to skeletal muscle tissue by stimulating muscle protein synthesis rates.
There have been multiple attempts to identify specialized performance nutrition products (e.g., various isolated protein powders) to maximize the anabolic properties of dietary protein on muscle.
Our research group, however, has advocated for a food focus approach to meet dietary protein requirements.
Particularly, we propose that whole foods demonstrate food matrix effects (nutrient-nutrient interactions) that creates a greater anabolic action on muscle beyond what amino acids can create alone.
Therefore, the objective of this study is to identify the anabolic properties of consuming lipid-rich pork products when compared to their leaner counter-parts.
Our working hypothesis that the ingestion of 84% or 96% lean ground pork condition will stimulate a greater increase in muscle protein synthesis rates compared to an isocaloric carbohydrate beverage in healthy adults.
We further hypothesize that the ingestion of 84% lean pork will augment the stimulation of muscle protein synthesis rates to a greater extent than 96% lean ground pork.
To achieve our objective, we will recruit 15 healthy men and women (20-50 y) to receive prime-constant infusions to directly measure muscle protein synthesis rates before and after treatment ingestion using our lab's established methods.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
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 Contact
- Name: Andrew T Askow, MS
- Phone Number: (608) 630-0237
- Email: askow2@illinois.edu
Study Locations
-
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Illinois
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Urbana, Illinois, United States, 61801
- Recruiting
- Louise Freer Hall (University of Illinois Urbana-Champaign)
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Contact:
- Nicholas A Burd, PhD
- Phone Number: 217-244-0970
- Email: naburd@illinois.edu
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-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 20-50 yrs
- Pre-menopausal
- Recreationally active
- Weight stable for prior 6 months
Exclusion Criteria:
- Age outside of range (20 - 50 yrs)
- Pregnancy
- Irregular menstrual cycles
- Participation in previous research using [13C6]phenylalanine
- Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.)
- Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year
- Allergy or hypersensitivity to local anesthetics, latex, or adhesives (bandages, medical tape, etc.)
- Excess scarring after injury
- History of excess bleeding after cut
- Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness
- Arthritis
- Tumors
- Mental Illness
- Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder
- Predisposition to hypertrophic scarring or keloid formation
- Physical activity limitations
- Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
- Consumption of thyroid, androgenic, or other medications known to affect endocrine function
- Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
- Unwillingness to comply with study procedures
- Weight unstable (variation >5% of bodyweight in last 6-12 months)
- Current or previous tobacco use with last 6 months
- Obesity (body mass index; BMI > 30 kg/m^2)
- Score of less than 14 or greater than 24 on Godin-Shephard Leisure-Time Physical Activity Questionnaire
- Phenylketonuria
- Anyone hospitalized previously for COVID-19 without a cardiovascular workup screening for cardiovascular issues post-infection
- Anyone recovering from COVID-19 infection within the preceding 10 days
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Carbohydrate Control
This condition will consist of a carbohydrate beverage.
|
This intervention will contain 266 kcals and 73.3 g carbohydrate from a carbohydrate beverage.
|
Active Comparator: Low-Fat Pork
This condition will consist of consuming 90.2 g of low-fat (4.90% crude fat) ground pork.
|
This intervention will contain 120 kcals, 4.4 g fat, and 20 g protein from low-fat ground pork.
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Experimental: High-Fat Pork
This condition will consist of consuming 109.6 g of high-fat (18.84% crude fat) ground pork.
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This intervention will contain 266 kcals, 20.6 g fat, and 20 g protein from high-fat ground pork.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myofibrillar Fractional Synthetic Rate
Time Frame: During 5-hour post-prandial period following consumption of the study meal or beverage
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Rate of building new protein in skeletal muscle contractile protein
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During 5-hour post-prandial period following consumption of the study meal or beverage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Amino Acid Concentration
Time Frame: During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
|
Concentration of amino acids in plasma as determined by LC/MS/MS
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During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
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Plasma Free Fatty Acid Concentration
Time Frame: During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
|
Concentration of amino acids in plasma as determined by GC-MS
|
During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
|
Plasma Insulin Concentration
Time Frame: During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
|
Concentration of insulin in plasma as determined by commercially-available ELISA kits
|
During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
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Plasma Glucose Concentration
Time Frame: During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
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Concentration of glucose in plasma as determined by an automated biochemistry analyzer (YSI)
|
During the 3-hour post-absorptive period prior to ingestion of the study meal or beverage and throughout the 5-hour post-prandial period following meal ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicholas A Burd, PhD, University of Illinois at Urbana-Champaign
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)
July 15, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
May 16, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 23257
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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