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

Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients

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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Study Overview

• Status: Unknown
• Conditions: Recovery of Function
• Intervention / Treatment: Dietary supplement: Nicotinamide Riboside and Pterostilbene; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center
      • Contact: Jonathan Kolansky
      • Contact: Email: Jonathan.Kolansky@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basis; Nicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days	Dietary supplement: Nicotinamide Riboside and Pterostilbene; Nicotinamide riboside and pterostilbene manufactured by Basis; Other Names: Basis; NRPT
Placebo Comparator: Placebo; Placebo given twice daily for 90 days	Dietary supplement: Placebo; Sugar pill manufactured to mimic Basis supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	To analyze patient complications through daily adverse event monitoring and summarize adverse events for each arm	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength Scores	To measure if BasisTM preserves or improves grip strength using Jamar hand dynamo-meter in non-dominant hand	90 days
Inhalation Volume Measurements	To measure if BasisTM preserves or improves lung volume by measuring inhaled volumes using incentive spirometry	90 days
6 Minute Timed Walk Test Scores	To measure if BasisTM preserves or improves 6 minute Timed Walk Test according to the AmericanThoracic Society Guidelines.	90 days
Timed Get Up and Go Test Scores	To measure if BasisTM preserves or improves timed get up and go scores	90 days
Measurement of Muscle/ Fat Ratio	To measure if BasisTM preserves or improves physiologic composition (muscle/fat) ratio) using bioelectric impedance	90 days
Incidence of Adverse Events	To analyze if BasisTM decreases 90 day incidence of recurrent falls	90 days
Incidence of Pain and Daily Pain Medication Dosage	To analyze the impact of BasisTM on subjective well-being pain through measurement of pain medication amounts and frequency.	90 days
Analysis of Quality of Life Scores	To analyze the impact of BasisTM on subjective well-being through analysis of EuroQol 5 Dimensions-5 Levels (EQ-5D-5L) scores and EuroQol Visual Analogue Scale (EQ Vas). EQ-5D-5L Scores consist of 5 sections: Mobility, Self-Care, Usual Activities, Pain/ discomfort and Anxiety/ Depression. The minimum score in each is 1, and the maximum is 5, where 5 indicates extreme problems and 1 indicates no problems. A total of 3125 possible health states exist and each stats is referred to in terms of a 5 digit code. State 11111 indicates no problems on any of the 5 dimensions, whereas state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. The EQ-VAS is scored from 0 to 100 where 0 means the worst health you can imagine and 100 means the best health you can imagine.	90 days
Late Life Function and Disability Instrument Scores analysis as a measure of subject independence, function, and disability	To analyze the impact of BasisTM on subjective well-being through analysis of Late Life Function and Disability Scores. Questions are scored on a scale of 5 to 1, where 1 means no difficulties with function and 1 means patients are unable to complete the functions on their own. Disability questions are scored from 1 to 5, where 1 means subjects do not complete activities and feel limited and 5 means subjects can complete activities and don't feel at all limited. Scores are computed using the LLFDI Scoring Software.	90 days
Analysis of scores on Mini Mental Status Exam as a measure of cognitive function and dementia	To analyze the impact of BasisTM on subjective well-being through analysis of Mini Mental Status Scores. The maximum score is 30 and the sections are orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), language and praxis (9 points). 0 is the lowest and 30 is the best score.	90 days
Analysis of subject nutrition through Mini Nutritional Assessment Scores	To analyze the impact of BasisTM on subjective well-being through analysis of Mini Nutritional Assessment scores. The maximum score is 14 points and the lowest (worst score) is 0.	90 days
Analysis of Subject independence using Barthel Index scores	To analyze the impact of BasisTM on subjective well-being through analysis of Barthel Index Scores. The index consists of 10 Activities of daily living, 8 of which represent activities related to personal care while 2 are related to mobility. The index yields a total score out of 100 with higher scores indicating greater degrees of functional independence.	90 days
Analysis of patient comorbidities as a measure of adverse events in evaluating Basis tolerability	To analyze the impact of BasisTM on subjective well-being through analysis of Charlson comorbidity index scores. The CCI accounts for 19 pre-defined comorbid conditions and is given a different weight depending on each's association with 1-year mortality. The total score in CCI is determined by the combined weight of the patient's conditions, where higher scores represent worse conditions.	90 days
Analysis of inflammatory cell activity	To measure if BasisTM alters Nicotinamide adenine dinucleotide (NAD) and sirtuin activity in inflammatory cells. Liquid chromatography mass spectrometry will assay for NAD.	90 days
Analysis of Mitochondrial Function	Mitochondrial content will be determined by citrate synthase activity. Mitochondrial respiration and the generation of reactive oxygen species will be measured using high-resolution respirometry and fluoremtry.	90 days

Collaborators and Investigators

• Sponsor: Elysium Health
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Carrie Sims, Univeristy of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 829947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No