NCT03635411

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

Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Elysium Health · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recovery of Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nicotinamide Riboside and Pterostilbene	Nicotinamide riboside and pterostilbene manufactured by Basis
DIETARY_SUPPLEMENT	Placebo	Sugar pill manufactured to mimic Basis supplement.

Timeline

• Start date: 2018-12-06
• Primary completion: 2020-11-01
• Completion: 2020-12-01
• First posted: 2018-08-17
• Last updated: 2020-01-06

Locations

1 site across 1 country: United States