Sarcopenia
Conditions
Brief 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 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.
Interventions
DIETARY_SUPPLEMENT6.3 g of EAAs mixture and whey protein isolate
A single dose of the mixture of EAAs/whey
DIETARY_SUPPLEMENT12.6 g of EAAs mixture and whey protein isolate
A double dose of the mixture of EAAs/whey
DIETARY_SUPPLEMENT12.6 g of whey protein isolate
Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 20 and 30 kg/m\^2
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein Anabolism | Change from 4.5 to 8.5 hours. | Changes in net protein balance at whole body (grams) |
| Protein Synthesis | From 4.5 to 8.5 hours. | Changes in protein synthesis in muscle (percent) |
Countries
United States
Participant flow
Pre-assignment details
Of the 16 subjects enrolled, 8 were randomized into an arm that has a crossover component of two study interventions. The other 8 subjects were randomized into a control arm that had only one intervention.
Participants by arm
| Arm | Count |
|---|---|
| EAAs/Whey: 6.3g First, Then 12.6g Subjects will consume 6.3 g of EAAs/whey in \
12 oz water on 1 day. Then washout at least 5 days. Then consume 12.6 g of study product at another visit. | 3 |
| EAAs/Whey: 12.6g First, Then 6.3g Subjects will consume 12.6 g of EAAs/whey in \
12 oz water on 1 day. Then washout at least 5 days. Then consume 6.3 g of study product at another visit. | 5 |
| Whey Protein Alone Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | EAAs/Whey: 6.3g First, Then 12.6g | EAAs/Whey: 12.6g First, Then 6.3g | Whey Protein Alone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Protein Anabolism
Changes in net protein balance at whole body (grams)
Time frame: Change from 4.5 to 8.5 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Single Dose of EAAs/Whey | Protein Anabolism | 3.56 grams | Standard Deviation 1.89 |
| A Double Dose of EAAs/Whey | Protein Anabolism | 11.8 grams | Standard Deviation 1.79 |
| Whey Protein Alone | Protein Anabolism | 3.02 grams | Standard Deviation 0.91 |
p-value: <0.05t-test, 2 sided
Primary
Protein Synthesis
Changes in protein synthesis in muscle (percent)
Time frame: From 4.5 to 8.5 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Single Dose of EAAs/Whey | Protein Synthesis | 0.024 percent change | Standard Deviation 0.048 |
| A Double Dose of EAAs/Whey | Protein Synthesis | 0.044 percent change | Standard Deviation 0.038 |
| Whey Protein Alone | Protein Synthesis | 0.022 percent change | Standard Deviation 0.041 |
p-value: <0.05ANOVA