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The investigators will examine the effects of 12-weeks of nutritional interventions in older participants who have a symptom of mild to moderate heart failure.
Heart failure develops when cardiac muscle becomes weakened and consequently is compromised in its ability to contract, relax, or both. Impaired heart function leads to reduced exercise capacity, which in turn leads to progressive muscle weakness and a vicious cycle of sedentary behavior, weight gain, and subsequent development of metabolic abnormalities and sarcopenia. Approximately 6-10% of individuals over the age of 65 suffer from heart failure, and the risk of death is 35% in the first year after diagnosis. In addition, there is a wide range of potential causes of heart failure, including the natural process of aging. Regardless of the specific underlying cause, there are common pathophysiological responses such as impaired exercise capacity, shortness of breath, fatigue and muscle strength, leading to decreased physical function. Moreover, some long-term consequences of reduced exercise tolerance and malabsorption in long-standing heart failure are loss of muscle mass and the development of cardiac cachexia, resulted in progression of sarcopenia. As protein and amino acid supplements are known to prevent loss of muscle mass or maintain muscle mass in alder individuals, in a pilot study 18 overweight/obese subjects with heart failure (all exceeded 40% body fat) were studied. Nine subjects received 12 weeks of dietary supplementation with 20 g of whey protein consumed daily, while the other nine were controls. The findings showed that supplementation with whey protein failed to improve functional performance as well as a limited stimulation of muscle protein synthesis. The lack of a demonstrable effect of whey protein is consistent with the diminished responsiveness to the stimulation of muscle protein synthesis. In contrast, a 2016 University of Arkansas for Medical Sciences (UAMS) pilot study found that the essential amino acid (EAA) mixture is better at overcoming anabolic resistance than Ensure Heart Health. In this study we will perform a randomized clinical trial of a commercially produced nutritional supplement as compared to a placebo in order to determine effects on physical function and health-related quality of life. Subjects will ingest either the EAA mixture product or placebo every day for 12 consecutive weeks. Outcomes will be determined by comparing the results of physical and functional tests from weeks -1 to 6 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9g of EAA mixture supplement | Experimental | Twice a day for 12 consecutive weeks. |
|
| 9g of placebo (whey protein) | Experimental | Twice a day for 12 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EAA mixture | Dietary Supplement | Dietary supplement intervention for 12-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Test | Measuring 6 minutes walking before and after the intervention. ***The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention. | Change from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gohar Azhar, M.D | 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 |
|---|---|---|---|
| 36720768 | Derived | Azhar G, Verma A, Zhang X, Pangle A, Patyal P, Zhang W, Che Y, Coker K, Wolfe RR, Wei JY. Differential plasma protein expression after ingestion of essential amino acid-based dietary supplement verses whey protein in low physical functioning older adults. Geroscience. 2023 Jun;45(3):1729-1743. doi: 10.1007/s11357-023-00725-5. Epub 2023 Feb 1. | |
| 33475727 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 9g of EAA Mixture Supplement | Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks |
| FG001 | 9g of Placebo (Whey Protein) | Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 9g of EAA Mixture Supplement | Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks |
| BG001 | 9g of Placebo (Whey Protein) | Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Functional Test | Measuring 6 minutes walking before and after the intervention. ***The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention. | Posted | Mean | Standard Deviation | feet | Change from baseline to 12 weeks |
|
Subjects were followed for adverse events for the duration of their participation (approx. 4 months).
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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 | 9g of EAA Mixture Supplement | Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate pain during urination | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Schutzler, R.N. | University of Arkansas for Medical Sciences | 501-526-5734 | seschutzler@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 | Jun 27, 2018 | Jul 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Placebo (whey protein) | Dietary Supplement | Dietary supplement intervention for 12-weeks |
|
|
| Azhar G, Wei JY, Schutzler SE, Coker K, Gibson RV, Kirby MF, Ferrando AA, Wolfe RR. Daily Consumption of a Specially Formulated Essential Amino Acid-Based Dietary Supplement Improves Physical Performance in Older Adults With Low Physical Functioning. J Gerontol A Biol Sci Med Sci. 2021 Jun 14;76(7):1184-1191. doi: 10.1093/gerona/glab019. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 9g of Placebo (Whey Protein) | Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks | 3 | 34 | 0 | 34 | 3 | 34 |
| Respiratory issue | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |