Clinical trial NCT03635411: Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET)
Official title: Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recovery of Function
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2018-08-17
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessing Safety and Tolerability
Primary purpose: OTHER

Brief summary: Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET) A phase I, randomized, double-blind, placebo-controlled, single institutional pilot trial investigating the impact of nicotinamide riboside/pterstilbene (BasisTM) on functional recovery after traumatic fall in elderly patients

.

Detailed description: This Phase I pilot study will determine if supplementing with the combination of NR and Pter (BasisTM) is well tolerated and will provide the pretrial data necessary to plan a randomized clinical trial aimed at determining if BasisTM improves the functional outcome of injured elderly patients.

Primary Objective

• To determine if BasisTM is well tolerated by elderly patients up to 90 days post injury

Secondary Objectives:

* To determine if BasisTM preserves or improves muscular strength, endurance, and activity following traumatic injury in elders.
* To determine if BasisTM preserves or improves physiologic composition (muscle/fat ratio) following traumatic injury in elders.
* To determine if BasisTM decreases 90 day incidence of recurrent falls
* To determine the impact of BasisTM on subjective well-being (pain) and quality of life (EQ-5D-5L)
* To determine if BasisTM alters NAD and sirtuin activity in inflammatory cells.

Elderly trauma patients who present after a traumatic injury will be screened and enrolled within 48 hours of their trauma evaluation. Baseline status will be determined using functional surveys, physical assessments, and physiologic measurements. Patients will be randomized to either BasisTM or placebo for 90 days. Patients will be reassessed at 2 weeks, 6 weeks (optional) and 90 days. Activity and heart rate will be monitored continuously using a wrist FitBit Device.

Eligibility criteria: Inclusion Criteria:

1. ≥ 65 year old
2. Patient presenting to trauma bay

Exclusion Criteria:

1. Currently taking medication for severe to moderate dementia (see Appendix 9)
2. Currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside
3. Pre-existing immobility (wheel chair or bed bound)
4. Renal failure requiring hemodialysis or peritoneal dialysis
5. End-stage Liver Disease (Model for End Stage Liver Disease Score ≥ 25) (see Appendix 11)
6. Intubated prior to enrollment (excluding intubation for surgery)
7. More than 48 hours post-injury
8. Thoracic Anatomic Injury Score \> 3 (see Appendix 10)
9. Other Injuries with Anatomic Injury Score \>2, excluding thorax (see Appendix 10)
10. Hip fractures
11. Non-English speaking

Primary outcomes:
measure: Complications
timeFrame: 90 days
Secondary outcomes:
measure: Grip Strength Scores
timeFrame: 90 days
measure: Inhalation Volume Measurements
timeFrame: 90 days
measure: 6 Minute Timed Walk Test Scores
timeFrame: 90 days
measure: Timed Get Up and Go Test Scores
timeFrame: 90 days
measure: Measurement of Muscle/ Fat Ratio
timeFrame: 90 days
measure: Incidence of Adverse Events
timeFrame: 90 days
measure: Incidence of Pain and Daily Pain Medication Dosage
timeFrame: 90 days
measure: Analysis of Quality of Life Scores
timeFrame: 90 days
measure: Late Life Function and Disability Instrument Scores analysis as a measure of subject independence, function, and disability
timeFrame: 90 days
measure: Analysis of scores on Mini Mental Status Exam as a measure of cognitive function and dementia
timeFrame: 90 days
measure: Analysis of subject nutrition through Mini Nutritional Assessment Scores
timeFrame: 90 days
measure: Analysis of Subject independence using Barthel Index scores
timeFrame: 90 days
measure: Analysis of patient comorbidities as a measure of adverse events in evaluating Basis tolerability
timeFrame: 90 days
measure: Analysis of inflammatory cell activity
timeFrame: 90 days
measure: Analysis of Mitochondrial Function
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: Univeristy of Pennsylvania
name: Carrie Sims
role: PRINCIPAL_INVESTIGATOR
References: