AgingPhase 1GRIPSNCT03904615
Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation
A Phase 1 study testing Whey Protein and Collagen Protein in people with Aging, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Whey Protein and Collagen Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2019to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older.
- Admitted to UTMB hospital for any acute medical condition
- English speaking
Who cannot join
- 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
- Any other condition or event considered exclusionary by the PI and faculty physician
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UTMB Acute Care for Elders Unit
Galveston, Texas, 77550
Jennie Sealy Hospital
Galveston, Texas, 77555
About this study
Official title: A Phase I Randomized Clinical Trial of In-hospital and Post-hospital Whey Protein vs. Low Quality Protein vs. Isocaloric Placebo Supplementation to Improve Recovery From Hospitalization in Older Adults
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.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- Whey Protein, Collagen Protein, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary supplement
30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
Collagen ProteinDietary supplement
30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
PlaceboDietary supplement
30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein | Active comparator | 30 g of whey protein twice daily during hospitalization and for 30 days after discharge Receives: Dietary Supplement: Whey Protein |
| Collagen Protein | Active comparator | 30 g of collagen protein twice daily during hospitalization and for 30 days after discharge Receives: Dietary Supplement: Collagen Protein |
| Placebo | Placebo comparator | 30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance
Measured: Change from baseline to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start19 Jun 2019
- Primary completion18 Mar 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized double blind phase 1 trial of 3 interventions
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Elena Volpi, MD, PhD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904615
- Sponsor's protocol ID
- 18-0247
- Acronym
- GRIPS
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2019
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Clinical Trial of In-hospital and Post-hospital Whey Protein vs. Low Quality Protein vs. Isocaloric Placebo Supplementation to Improve Recovery From Hospitalization in Older Adults
- ClinicalTrials.gov ID
- NCT03904615
- Acronym / sponsor ID
- GRIPS / 18-0247
- Conditions
- Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel randomized double blind phase 1 trial of 3 interventions
| Arm | Type | Receives |
|---|---|---|
| Whey Protein | Active comparator | Dietary Supplement: Whey Protein30 g of whey protein twice daily during hospitalization and for 30 days after discharge |
| Collagen Protein | Active comparator | Dietary Supplement: Collagen Protein30 g of collagen protein twice daily during hospitalization and for 30 days after discharge |
| Placebo | Placebo comparator | Dietary Supplement: Placebo30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years or older.
- Admitted to UTMB hospital for any acute medical condition
- English speaking
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge | Dietary supplement | Whey Protein |
| Collagen Protein30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge | Dietary supplement | Collagen Protein |
| Placebo30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge | Dietary supplement | Placebo |
Primary outcome
Physical Function
Time frame: Change from baseline to 30 days after discharge
Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No. No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Volpi, MD, PhD principal investigator
UTMB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Whey Protein and Collagen Protein in people with Aging, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: Change from baseline to 30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.