Recovery of FunctionPhase 1BestBetNCT03635411
Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients (BES2T BET)
A Phase 1 study testing Nicotinamide Riboside and Pterostilbene in people with Recovery of Function, run by Elysium Health at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Recovery of Function
- What is being tested?
- Nicotinamide Riboside and Pterostilbene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to Dec 2020
- 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
- ≥ 65 year old
- Patient presenting to trauma bay
Who cannot join
- Currently taking medication for severe to moderate dementia (see Appendix 9)
- Currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside
- Pre-existing immobility (wheel chair or bed bound)
- Renal failure requiring hemodialysis or peritoneal dialysis
- End-stage Liver Disease (Model for End Stage Liver Disease Score ≥ 25) (see Appendix 11)
- Intubated prior to enrollment (excluding intubation for surgery)
Show all 11Show fewer
- More than 48 hours post-injury
- Thoracic Anatomic Injury Score > 3 (see Appendix 10)
- Other Injuries with Anatomic Injury Score >2, excluding thorax (see Appendix 10)
- Hip fractures
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Jonathan Kolansky
Jonathan.Kolansky@pennmedicine.upenn.edu
About this study
Official title: 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
.
Read the 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
- Being tested
- Nicotinamide Riboside and Pterostilbene, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside and PterostilbeneDietary supplement
Also called Basis, NRPT
Nicotinamide riboside and pterostilbene manufactured by Basis
PlaceboDietary supplement
Sugar pill manufactured to mimic Basis supplement.
| Study group | Role | What they receive |
|---|---|---|
| Basis | Experimental | Nicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days Receives: Dietary Supplement: Nicotinamide Riboside and Pterostilbene |
| Placebo | Placebo comparator | Placebo given twice daily for 90 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
To analyze patient complications through daily adverse event monitoring and summarize adverse events for each arm
Measured: 90 days
Secondary outcomes (15)
Grip Strength Scores
To measure if BasisTM preserves or improves grip strength using Jamar hand dynamo-meter in non-dominant hand
Measured: 90 days
Inhalation Volume Measurements
To measure if BasisTM preserves or improves lung volume by measuring inhaled volumes using incentive spirometry
Measured: 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.
Measured: 90 days
Timed Get Up and Go Test Scores
To measure if BasisTM preserves or improves timed get up and go scores
Measured: 90 days
Measurement of Muscle/ Fat Ratio
To measure if BasisTM preserves or improves physiologic composition (muscle/fat) ratio) using bioelectric impedance
Measured: 90 days
Incidence of Adverse Events
To analyze if BasisTM decreases 90 day incidence of recurrent falls
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start6 Dec 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery of FunctionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessing Safety and Tolerability
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Carrie Sims, Principal investigator, Univeristy of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635411
- Sponsor's protocol ID
- 829947
- Acronym
- BestBet
- Status last verified
- Jan 2020
- First submitted
- 7 Aug 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basis: Evaluating Sirtuin Supplements To Benefit Elderly Trauma Patients
- ClinicalTrials.gov ID
- NCT03635411
- Acronym / sponsor ID
- BestBet / 829947
- Conditions
- Recovery of Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Aug 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Assessing Safety and Tolerability
| Arm | Type | Receives |
|---|---|---|
| Basis | Experimental | Dietary Supplement: Nicotinamide Riboside and PterostilbeneNicotinamide riboside 500 mg and pterostilbene 100 mg given twice daily in divided doses for 90 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo given twice daily for 90 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ≥ 65 year old
- Patient presenting to trauma bay
Key exclusion criteria (11 listed)
- Currently taking medication for severe to moderate dementia (see Appendix 9)
- Currently taking niacin, nicotinic acid, nicotinamide, or nicotinamide riboside
- Pre-existing immobility (wheel chair or bed bound)
- Renal failure requiring hemodialysis or peritoneal dialysis
- End-stage Liver Disease (Model for End Stage Liver Disease Score ≥ 25) (see Appendix 11)
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 |
|---|---|---|
| Nicotinamide Riboside and PterostilbeneAlso: Basis, NRPTNicotinamide riboside and pterostilbene manufactured by Basis | Dietary supplement | Basis |
| PlaceboSugar pill manufactured to mimic Basis supplement. | Dietary supplement | Placebo |
Primary outcome
Complications
Time frame: 90 days
To analyze patient complications through daily adverse event monitoring and summarize adverse events for each arm
15 secondary outcomes
Grip Strength Scores
Time frame: 90 days
Inhalation Volume Measurements
Time frame: 90 days
6 Minute Timed Walk Test Scores
Time frame: 90 days
Timed Get Up and Go Test Scores
Time frame: 90 days
Measurement of Muscle/ Fat Ratio
Time frame: 90 days
Incidence of Adverse Events
Time frame: 90 days
Incidence of Pain and Daily Pain Medication Dosage
Time frame: 90 days
Analysis of Quality of Life Scores
Time frame: 90 days
Late Life Function and Disability Instrument Scores analysis as a measure of subject independence, function, and disability
Time frame: 90 days
Analysis of scores on Mini Mental Status Exam as a measure of cognitive function and dementia
Time frame: 90 days
Analysis of subject nutrition through Mini Nutritional Assessment Scores
Time frame: 90 days
Analysis of Subject independence using Barthel Index scores
Time frame: 90 days
Analysis of patient comorbidities as a measure of adverse events in evaluating Basis tolerability
Time frame: 90 days
Analysis of inflammatory cell activity
Time frame: 90 days
Analysis of Mitochondrial Function
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Carrie Sims principal investigator
Univeristy of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotinamide Riboside and Pterostilbene in people with Recovery of Function, run by Elysium Health at 1 site 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carrie Sims (215-662-8819, carrie.sims@uphs.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 90 days). 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 6 Jan 2020.