SarcopeniaNCT03502941
Effect of an EAA/Whey Composition on Protein Metabolism
A study testing 6.3 g of EAAs mixture and whey protein isolate, 12.6 g of EAAs mixture and whey protein isolate and 12.6 g of whey protein isolate in people with Sarcopenia, run by University of Arkansas at 1 site in United States.
Trial summary
Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. While it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (EAAs) and whey protein increases anabolic… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- 6.3 g of EAAs mixture and whey protein isolate, 12.6 g of EAAs mixture and whey protein isolate and 12.6 g of whey protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 20 and 30 kg/m^2
Who cannot join
- Current diagnosis of diabetes
- History of malignancy in the 6 months prior to enrollment
- Weight reduction surgery
- Chronic inflammatory (Lupus, HIV/AIDS)
- Currently pregnant females
- Unable to eat dairy protein
Show all 12Show fewer
- Unable to stop eating protein or Amino Acid (AA) supplements during the participation
- Regular resistance training (> once per week)
- Concomitant use of corticosteroids (ingestion, injection or transdermal)
- Subjects who cannot safely stop using aspirin for 7 days prior to muscle biopsies
- Hemoglobin less than 9.5 g/dL, and platelets less than 150,000 at the screening visit
- Any other disease or condition placing the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism
Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. While it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (EAAs) and whey protein increases anabolic response. The current study will test if a specially formulated mixture of EAAs and whey protein can maximally stimulate anabolic responses at the levels of whole body and muscle compared to whey protein alone.
Read the detailed description
The product composition is protected by intellectual property. It contains a combination of ingredients designed to stimulate anabolic responses at whole body and muscle and to ultimately induce long-term improvements in muscle function and size. EAAs are the only dietary macronutrients that are required for survival. They are "essential" because the body cannot produce them. There are 9 dietary EAAs while there are 11 dietary non-essential amino acids that are not required in the diet because they can be produced in the body. The composition is based on a blend of 8 of the 9 EAAs. In addition to being the "active" components of dietary protein, EAAs also have the advantage over intact protein including whey protein because free EAAs are absorbed from the intestine more quickly and more completely than amino acids contained in protein, which requires digestion before absorption indicating that intact protein is relatively slowly absorbed. Therefore, the combination of free EAAs and intact protein give not only an immediate response (from the free EAAs) but also a prolonged response (from the intact protein) over time by the slower digestion. The idea of combining a specific formulation of EAAs with an intact protein to obtain both an immediate as well as a more sustained response in protein anabolism is novel. Investigators propose that consumption of the EAA/protein composition will stimulate the net protein balance at the whole body level in a dose-dependent manner. The investigators further propose that the magnitude of increase in the net protein balance will be greater than induced by the consumption of the same amount of whey protein isolate.
- Conditions
- Sarcopenia
- Being tested
- 6.3 g of EAAs mixture and whey protein isolate, 12.6 g of EAAs mixture and whey protein isolate, 12.6 g of whey protein isolate
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6.3 g of EAAs mixture and whey protein isolateDietary supplement
Also called Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)
A single dose of the mixture of EAAs/whey
12.6 g of EAAs mixture and whey protein isolateDietary supplement
Also called Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY
A double dose of the mixture of EAAs/whey
12.6 g of whey protein isolateDietary supplement
Also called Pure Protein, Bayport, NY
Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
| Study group | Role | What they receive |
|---|---|---|
| A single dose of EAAs/whey | Experimental | Subjects will consume 6.3 g of EAAs/whey in ~12 oz water. Receives: Dietary Supplement: 6.3 g of EAAs mixture and whey protein isolate |
| A double dose of EAAs/whey | Experimental | Subjects will consume 12.6 g of EAAs/whey in ~12 oz water Receives: Dietary Supplement: 12.6 g of EAAs mixture and whey protein isolate |
| Whey protein alone | Experimental | Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. Receives: Dietary Supplement: 12.6 g of whey protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Anabolism
Changes in net protein balance at whole body (grams)
Measured: Change from 4.5 to 8.5 hours.
Protein Synthesis
Changes in protein synthesis in muscle (percent)
Measured: From 4.5 to 8.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start20 Jun 2018
- Primary completion9 Apr 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Crossover
- Model description
- Arm 1 and 2: Crossover design for two different doses of the product (\~6.3 and 12.6 g of active components). Arm 3: Parallel comparison equal to the double dose of whey protein isolate (12.6 g)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arny A Ferrando, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502941
- Sponsor's protocol ID
- 217658
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2018
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park S, Church DD, Azhar G, Schutzler SE, Ferrando AA, Wolfe RR. Anabolic response to essential amino acid plus whey protein composition is greater than whey protein alone in young healthy adults. J Int Soc Sports Nutr. 2020 Feb 10;17(1):9. doi: 10.1186/s12970-020-0340-5.
PubMed 32041644
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism
- ClinicalTrials.gov ID
- NCT03502941
- Acronym / sponsor ID
- 217658
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. While it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (EAAs) and whey protein increases anabolic response. The current study will test if a specially formulated mixture of EAAs and whey protein can maximally stimulate anabolic responses at the levels of whole body and muscle compared to whey protein alone.
Detailed description
The product composition is protected by intellectual property. It contains a combination of ingredients designed to stimulate anabolic responses at whole body and muscle and to ultimately induce long-term improvements in muscle function and size. EAAs are the only dietary macronutrients that are required for survival. They are "essential" because the body cannot produce them. There are 9 dietary EAAs while there are 11 dietary non-essential amino acids that are not required in the diet because they can be produced in the body. The composition is based on a blend of 8 of the 9 EAAs. In addition to being the "active" components of dietary protein, EAAs also have the advantage over intact protein including whey protein because free EAAs are absorbed from the intestine more quickly and more completely than amino acids contained in protein, which requires digestion before absorption indicating that intact protein is relatively slowly absorbed. Therefore, the combination of free EAAs and intact protein give not only an immediate response (from the free EAAs) but also a prolonged response (from the intact protein) over time by the slower digestion. The idea of combining a specific formulation of EAAs with an intact protein to obtain both an immediate as well as a more sustained response in protein anabolism is novel. Investigators propose that consumption of the EAA/protein composition will stimulate the net protein balance at the whole body level in a dose-dependent manner. The investigators further propose that the magnitude of increase in the net protein balance will be greater than induced by the consumption of the same amount of whey protein isolate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Arm 1 and 2: Crossover design for two different doses of the product (~6.3 and 12.6 g of active components). Arm 3: Parallel comparison equal to the double dose of whey protein isolate (12.6 g)
| Arm | Type | Receives |
|---|---|---|
| A single dose of EAAs/whey | Experimental | Dietary Supplement: 6.3 g of EAAs mixture and whey protein isolateSubjects will consume 6.3 g of EAAs/whey in ~12 oz water. |
| A double dose of EAAs/whey | Experimental | Dietary Supplement: 12.6 g of EAAs mixture and whey protein isolateSubjects will consume 12.6 g of EAAs/whey in ~12 oz water |
| Whey protein alone | Experimental | Dietary Supplement: 12.6 g of whey protein isolateSubjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 20 and 30 kg/m^2
Key exclusion criteria (12 listed)
- Current diagnosis of diabetes
- History of malignancy in the 6 months prior to enrollment
- Weight reduction surgery
- Chronic inflammatory (Lupus, HIV/AIDS)
- Currently pregnant females
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 |
|---|---|---|
| 6.3 g of EAAs mixture and whey protein isolateAlso: Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)A single dose of the mixture of EAAs/whey | Dietary supplement | A single dose of EAAs/whey |
| 12.6 g of EAAs mixture and whey protein isolateAlso: Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NYA double dose of the mixture of EAAs/whey | Dietary supplement | A double dose of EAAs/whey |
| 12.6 g of whey protein isolateAlso: Pure Protein, Bayport, NYWhey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey | Dietary supplement | Whey protein alone |
Primary outcome
Protein Anabolism
Time frame: Change from 4.5 to 8.5 hours.
Changes in net protein balance at whole body (grams)
Protein Synthesis
Time frame: From 4.5 to 8.5 hours.
Changes in protein synthesis in muscle (percent)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32041644Park S, Church DD, Azhar G, Schutzler SE, Ferrando AA, Wolfe RR. Anabolic response to essential amino acid plus whey protein composition is greater than whey protein alone in young healthy adults. J Int Soc Sports Nutr. 2020 Feb 10;17(1):9. doi: 10.1186/s12970-020-0340-5.
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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.
Arny A Ferrando, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6.3 g of EAAs mixture and whey protein isolate, 12.6 g of EAAs mixture and whey protein isolate and 12.6 g of whey protein isolate in people with Sarcopenia, run by University of Arkansas 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 1 inclusion and 12 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 2 Nov 2021. 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. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Protein Anabolism (time frame: Change from 4.5 to 8.5 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502941, which also lists 1 linked publication.
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 2 Nov 2021.