Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

NCT03904615 | Completed Phase 1

• 1 other identifier: 18-0247
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Physical Function

  Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

  Change from baseline to 30 days after discharge

Study Arms (3)

Whey Protein

ACTIVE COMPARATOR

30 g of whey protein twice daily during hospitalization and for 30 days after discharge

Dietary Supplement: Whey Protein

Collagen Protein

ACTIVE COMPARATOR

30 g of collagen protein twice daily during hospitalization and for 30 days after discharge

Dietary Supplement: Collagen Protein

Placebo

PLACEBO COMPARATOR

30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge

Dietary Supplement: Placebo

Interventions

Whey Protein DIETARY_SUPPLEMENT

30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Whey Protein

Collagen Protein DIETARY_SUPPLEMENT

30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Collagen Protein

Placebo DIETARY_SUPPLEMENT

30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or older.
• Admitted to UTMB hospital for any acute medical condition
• English speaking

You may not qualify if:

• Inability to consent
• Bed or wheelchair bound prior to hospitalization
• Estimated creatinine clearance 20 ml/min or less, or end stage renal disease not on dialysis
• AST/ALT 2.5 times above the normal limit
• Active cancer
• Palliative care/Hospice
• Estimated protein intake \>1.2 g/kg/day during the previous 24 hours

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Dairy Management Inc.: collaborator

Study Sites (2)

UTMB Acute Care for Elders Unit

Galveston, Texas, 77550, United States

Location

Jennie Sealy Hospital

Galveston, Texas, 77555, United States

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elena Volpi, MD, PhD

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomized double blind phase 1 trial of 3 interventions

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 5, 2019
• Study Start: June 19, 2019
• Primary Completion: March 18, 2024
• Study Completion: October 31, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)