- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02918981
Nutritional Strategies to Augment the Postprandial Muscle Protein Synthetic Response to the Ingestion of a Low Dose of Protein in Middle-aged Women
November 2, 2020 updated by: Nicholas Burd, University of Illinois at Urbana-Champaign
Using stable isotope methodology, investigators will determine the postabsorptive and postprandial muscle protein synthetic response in 60 female adults (Age 50-79, BMI: <30 kg/m2) immediately after an acute bout of resistance exercise.
Participants will be divided in to 5 groups of twelve women (n=12).
Each group will receive a different protein beverage or placebo to consume following the resistance exercise training.
Group 1 will consume a beverage consisting of whey protein; group 2 will consume whey protein supplemented with additional leucine; group 3 will consume whey protein supplemented with additional leucine and hydrolyzed whey peptides; group 4 will consume whey protein supplemented with additional leucine and citrulline; group 5 will just consume water.
During the testing, blood and muscle samples will be collected.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI <30 kg/m2
- Healthy, sedentary
- Either 20-30 years old or 50-79 years old
Exclusion Criteria:
- Tobacco use
- Allergies to milk consumption
- Unusually high protein consumption
- Vegan diet
- Allergies to antibiotics or xylocaine
- Phenylketonuria (PKU)
- Diagnosed GI tract diseases
- Arthritic conditions
- A history of neuromuscular problems
- Heart disease
- Metabolic disorders
- -Liver, kidney, or urinary disease
- Musculoskeletal problems
- Autoimmune disease
- Neurological disease
- Previous participation in amino acid tracer studies
- Predisposition to hypertrophic scarring or keloid formation
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Individuals using thyroid medications or other medications affecting endocrine function
- Pregnancy
- Contraindications for exercise
- BMI ≥30
- 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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Whey protein
After resistance exercise, participants aged 50-79 years will consume 14g Whey protein dissolved in 200 mL of water
|
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
|
|
Experimental: Whey + Leucine
After resistance exercise, participants aged 50-79 years will consume 6.6 g Whey protein + 1.25 g Leucine dissolved in 200 mL of water
|
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
|
|
Experimental: Whey + Leucine + Whey peptides
After resistance exercise, participants aged 50-79 years will consume 4 g Whey protein + 1.25 g Leucine + 2.6 g Whey peptides dissolved in 200 mL of water
|
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
|
|
Experimental: Whey + Leucine + Citrulline
After resistance exercise, participants aged 50-79 years will consume 6.6 g Whey protein + 1.25 g Leucine + 0.8 g Citrulline dissolved in 200 mL of water
|
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
|
|
Sham Comparator: Water
After resistance exercise, participants aged either 20-30 or 50-79 years old will consume 200 mL water
|
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The myofibrillar protein synthetic response to protein ingestion
Time Frame: Postabsorptive for 3 hours, Postprandial for 4 hours hours
|
Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hr and during the 4 hr after the ingestion of the experimental beverages.
This will allow us to assess the change from the postabsorptive to the postprandial period
|
Postabsorptive for 3 hours, Postprandial for 4 hours hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mTORC1 phosphorylation
Time Frame: Baseline and at 2 and 4 hours after protein ingestion
|
Activation of anabolic signaling pathways will be assessed in the fasted state and at 2 and 4 hr after the ingestion of the experimental beverages.
|
Baseline and at 2 and 4 hours after protein ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicholas A Burd, Ph.D., University of Illinois at Chicago
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)
October 1, 2016
Primary Completion (Actual)
March 6, 2019
Study Completion (Actual)
March 6, 2019
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
September 27, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 16999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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