AgingNCT02918981
Nutritional Strategies to Augment the Postprandial Muscle Protein Synthetic Response to the Ingestion of a Low Dose of Protein in Middle-aged Women
A study testing Resistance Exercise, 14 g Whey protein and 6.6 g Whey protein + 1.25 g leucine in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistance Exercise, 14 g Whey protein and 6.6 g Whey protein + 1.25 g leucine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 6 Mar 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 20 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI <30 kg/m2
- Healthy, sedentary
- Either 20-30 years old or 50-79 years old
Who cannot join
- Tobacco use
- Allergies to milk consumption
- Unusually high protein consumption
- Vegan diet
- Allergies to antibiotics or xylocaine
- Phenylketonuria (PKU)
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aging
- Being tested
- Resistance Exercise, 14 g Whey protein, 6.6 g Whey protein + 1.25 g leucine, 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides, 6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
14 g Whey proteinDietary supplement
6.6 g Whey protein + 1.25 g leucineDietary supplement
4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptidesDietary supplement
6.6 g Whey protein + 1.25 g leucine + 0.8 g CitrullineDietary supplement
Water controlOther
| Study group | Role | What they receive |
|---|---|---|
| Whey protein | Active comparator | After resistance exercise, participants aged 50-79 years will consume 14g Whey protein dissolved in 200 mL of water Receives: Behavioral: Resistance Exercise; Dietary Supplement: 14 g Whey protein |
| Whey + Leucine | Experimental | 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 Receives: Behavioral: Resistance Exercise; Dietary Supplement: 6.6 g Whey protein + 1.25 g leucine |
| Whey + Leucine + Whey peptides | Experimental | 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 Receives: Behavioral: Resistance Exercise; Dietary Supplement: 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides |
| Whey + Leucine + Citrulline | Experimental | 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 Receives: Behavioral: Resistance Exercise; Dietary Supplement: 6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline |
| Water | Sham comparator | After resistance exercise, participants aged either 20-30 or 50-79 years old will consume 200 mL water Receives: Behavioral: Resistance Exercise; Other: Water control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The myofibrillar protein synthetic response to protein ingestion
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
Measured: Postabsorptive for 3 hours, Postprandial for 4 hours hours
Secondary outcomes (1)
mTORC1 phosphorylation
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.
Measured: Baseline and at 2 and 4 hours after protein ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Burd, University of Illinois at Urbana-Champaign
- Investigators
- Nicholas A Burd, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918981
- Sponsor's protocol ID
- 16999
- Status last verified
- Nov 2020
- First submitted
- 20 Sep 2016
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Strategies to Augment the Postprandial Muscle Protein Synthetic Response to the Ingestion of a Low Dose of Protein in Middle-aged Women
- ClinicalTrials.gov ID
- NCT02918981
- Acronym / sponsor ID
- 16999
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 29 Sep 2016 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Whey protein | Active comparator | Behavioral: Resistance Exercise, Dietary Supplement: 14 g Whey proteinAfter resistance exercise, participants aged 50-79 years will consume 14g Whey protein dissolved in 200 mL of water |
| Whey + Leucine | Experimental | Behavioral: Resistance Exercise, Dietary Supplement: 6.6 g Whey protein + 1.25 g leucineAfter resistance exercise, participants aged 50-79 years will consume 6.6 g Whey protein + 1.25 g Leucine dissolved in 200 mL of water |
| Whey + Leucine + Whey peptides | Experimental | Behavioral: Resistance Exercise, Dietary Supplement: 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptidesAfter 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 |
| Whey + Leucine + Citrulline | Experimental | Behavioral: Resistance Exercise, Dietary Supplement: 6.6 g Whey protein + 1.25 g leucine + 0.8 g CitrullineAfter 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 |
| Water | Sham comparator | Behavioral: Resistance Exercise, Other: Water controlAfter resistance exercise, participants aged either 20-30 or 50-79 years old will consume 200 mL water |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI <30 kg/m2
- Healthy, sedentary
- Either 20-30 years old or 50-79 years old
Key exclusion criteria (23 listed)
- Tobacco use
- Allergies to milk consumption
- Unusually high protein consumption
- Vegan diet
- Allergies to antibiotics or xylocaine
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 ExerciseParticipants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage | Behavioural | Water, Whey + Leucine, Whey + Leucine + Citrulline, Whey + Leucine + Whey peptides, Whey protein |
| 14 g Whey protein | Dietary supplement | Whey protein |
| 6.6 g Whey protein + 1.25 g leucine | Dietary supplement | Whey + Leucine |
| 4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides | Dietary supplement | Whey + Leucine + Whey peptides |
| 6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline | Dietary supplement | Whey + Leucine + Citrulline |
| Water control | Other | Water |
Primary outcome
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
1 secondary outcome
mTORC1 phosphorylation
Time frame: Baseline and at 2 and 4 hours after protein ingestion
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 3 Nov 2020.
- 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.
Nicholas A Burd, Ph.D. principal investigator
University of Illinois Chicago
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 Exercise, 14 g Whey protein and 6.6 g Whey protein + 1.25 g leucine 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 3 inclusion and 23 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 3 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
The myofibrillar protein synthetic response to protein ingestion (time frame: Postabsorptive for 3 hours, Postprandial for 4 hours hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.