Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dairy Management Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the feasibility of nutritional interventions designed to help older patients maintain physical function after being in the hospital. We will test the feasibility and effect of nutritional interventions with whey protein, collagen or placebo on functional recovery from hospitalization in community dwelling older adults.
We will compare in a randomized parallel design double blind pilot phase I study the feasibility of whey protein vs. collagen vs. isocaloric placebo supplementation in older adults during an acute hospitalization for a medical condition, and the treatments' effect size on physical function after hospital discharge.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey Protein | Active Comparator | 30 g of whey protein twice daily during hospitalization and for 30 days after discharge |
|
| Collagen Protein | Active Comparator | 30 g of collagen protein twice daily during hospitalization and for 30 days after discharge |
|
| Placebo | Placebo Comparator | 30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein | Dietary Supplement | 30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance | Change from baseline to 30 days after discharge |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elena Volpi, MD, PhD | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTMB Acute Care for Elders Unit | Galveston | Texas | 77550 | United States | ||
| Jennie Sealy Hospital |
No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
Not provided
Not provided
Parallel randomized double blind phase 1 trial of 3 interventions
Not provided
Not provided
Not provided
| Collagen Protein | Dietary Supplement | 30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge |
|
| Placebo | Dietary Supplement | 30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge |
|
| Galveston |
| Texas |
| 77555 |
| United States |
| 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 |