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To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.
This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low | Experimental | Low dose (6.3g) EAA/whey protein supplement |
|
| High | Experimental | High dose (12.6g) EAA/whey protein supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral amino acid tracer | Other | Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body Protein Net Balance | grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations. | 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arny A Ferrando, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Translational Research in Aging and Longevity | Little Rock | Arkansas | 72205 | United States |
No IPD will be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Then High Dose | Low dose (6.3g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
| FG001 | High Dose Then Low Dose | High dose (12.6g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Then High | Low dose (6.3g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
| BG001 | High Dose Then Low |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole-body Protein Net Balance | grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations. | Posted | Mean | Standard Deviation | grams | 240 minutes |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Low dose (6.3g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Rose Hisrch, Ph.D. | The University of Arkansas for Medical Sciences | 5015265708 | krhirsch@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 | Apr 12, 2022 | Prot_SAP_000.pdf |
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double-blinded, randomized, crossover pilot study
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This will be a double-blinded study. Both SP amounts are dissolved into equal volumes of water so that subjects will not know which amount they are ingesting. Blood samples are coded so that lab staff and investigators will not know which amount of SP was consumed at each visit. Investigators will be unblinded after all samples have been processed and data analysis has taken place.
High dose (12.6g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | High Dose | High dose (12.6g) EAA/whey protein supplement Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer. | 0 | 8 | 0 | 8 | 0 | 8 |
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