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A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.
Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.
3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recommended dietary allowance (RDA) for protein | Experimental | (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
|
| Habitual protein intake consistent with population level norms | Experimental | (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
|
| Optimal protein intake (OPI) | Experimental | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommended Dietary Allowance of Protein | Other | 0.8 g/kg/day protein intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole Body Protein Turnover | Isotope Tracer | 24 hour |
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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 |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39736329 | Derived | Church DD, Hirsch KR, Kviatkovsky SA, Matthews JJ, Henderson RA, Azhar G, Wolfe RR, Ferrando AA. Effect of 3 Different Daily Protein Intakes in a 2-Meal Eating Pattern on Protein Turnover in Middle Age and Older Adults: A Randomized Controlled Trial. J Nutr. 2025 May;155(5):1364-1372. doi: 10.1016/j.tjnut.2024.12.025. Epub 2024 Dec 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recommended Dietary Allowance (RDA) for Protein | (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake |
| FG001 | Habitual Protein Intake Consistent With Population Level Norms | (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Habitual protein intake: 1.0 g/kg/day protein intake |
| FG002 | Optimal Protein Intake (OPI) | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Optimal Protein Intake: 1.5 g/kg/day protein intake |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recommended Dietary Allowance (RDA) for Protein | (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake |
| BG001 |
| 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 Turnover | Isotope Tracer | Posted | Mean | Standard Deviation | g/kg lean body mass/day | 24 hour |
|
Starting with enrollment and ending with completion of last study visit; in most cases within 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 | Recommended Dietary Allowance (RDA) for Protein | (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration from fall | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject fell and hit their head on the edge of a nearby table, causing a deep scalp laceration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration from fall | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David D. Church, Ph.D., Assistant Professor | University of Arkansas for Medical Sciences | 5015265709 | dchurch@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 | Dec 7, 2021 | Oct 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D009749 | Nutrition Surveys |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| Habitual protein intake | Other | 1.0 g/kg/day protein intake |
|
|
| Optimal Protein Intake | Other | 1.5 g/kg/day protein intake |
|
|
| Habitual Protein Intake Consistent With Population Level Norms |
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Habitual protein intake: 1.0 g/kg/day protein intake |
| BG002 | Optimal Protein Intake (OPI) | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Optimal Protein Intake: 1.5 g/kg/day protein intake |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Optimal Protein Intake (OPI) | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Optimal Protein Intake: 1.5 g/kg/day protein intake |
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| 6 |
| 18 |
| EG001 | Habitual Protein Intake Consistent With Population Level Norms | (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Habitual protein intake: 1.0 g/kg/day protein intake | 0 | 14 | 0 | 14 | 3 | 14 |
| EG002 | Optimal Protein Intake (OPI) | (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. Optimal Protein Intake: 1.5 g/kg/day protein intake | 0 | 12 | 0 | 12 | 5 | 12 |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| GI illness with reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |