Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET) (BestBet)

Elysium Health

Status and phase: Unknown; Phase 1

Conditions: Recovery of Function

Treatments: Dietary Supplement: Nicotinamide Riboside and Pterostilbene; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03635411

829947

Details and patient eligibility

About

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

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Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Basis

Experimental group

Description:

Nicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days

Treatment:

Dietary Supplement: Nicotinamide Riboside and Pterostilbene

Placebo

Placebo Comparator group

Description:

Placebo given twice daily for 90 days

Treatment:

Dietary Supplement: Placebo