Knee OsteoarthristisNRPTNCT07917403
Study NRPT Feasibility in Knee Osteoarthritis
A study testing NRPT in people with Knee Osteoarthristis, run by University of California, San Diego at 1 site in United States.
Trial summary
To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- NRPT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation.
- Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex.
- Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined from a standing knee radiograph obtained within the prior 12 months or at Screening.
- Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening.
- No changes in OA-directed therapy (including analgesics, NSAIDs, topical therapies, or non-pharmacologic regimens) in the 3 months prior to Screening.
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- Agreement to refrain from vitamin B3-containing supplements (nicotinic acid, nicotinamide, nicotinamide riboside) and any multivitamin containing these ingredients for at least 14 days prior to Baseline and throughout the duration of the study.
- Ability to take oral capsule medication and willingness to adhere to the prescribed NRPT regimen.
- Agreement to adhere to lifestyle considerations specified in Section 5.3 throughout the study.
Who cannot join
- Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement).
- Severe radiographic knee disease (KL grade 4) in the index knee.
- Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees).
- Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal arthropathy of the index knee).
- Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other polyphenol-containing supplements (including resveratrol, curcumin) within the 3 months prior to Screening.
- Self-reported substantive change in physical activity level (initiation of a new exercise program or cessation of regular activity) within the 3 months prior to Screening.
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- Pregnancy, lactation, or planning pregnancy during the study period. Women of childbearing potential must have a negative serum or urine pregnancy test at Screening.
- Severe or uncontrolled comorbid conditions that, in the opinion of the investigator, would compromise participant safety or interpretability of study data, including but not limited to: uncontrolled diabetes mellitus (HbA1c >9.0% or requiring recent insulin initiation); active cardiovascular disease (myocardial infarction, unstable angina, decompensated heart failure, or stroke within 6 months); severe chronic kidney disease (eGFR <30 mL/min/1.73 m²); active liver disease or AST/ALT >2.5× the upper limit of normal; active malignancy (other than non-melanoma skin cancer) within 5 years; or active substance use disorder.
- Known allergy or hypersensitivity to nicotinamide riboside, pterostilbene, resveratrol, or any excipient of Basis®.
- Concurrent participation in another interventional clinical trial or use of an investigational agent within 30 days prior to Screening.
- Any other condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the protocol or with the safety or scientific integrity of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSD, La Jolla, California
San Diego, California, 92093
Monica Guma, MD, Phd, 8588226523, mguma@ucsd.edu
About this study
Official title: A Prospective, Single-Arm, Open-Label Pilot Study to Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults With Knee Osteoarthritis
To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis
Read the detailed description
This exploratory study will evaluate the feasibility, tolerability, and preliminary effects of NRPT (nicotinamide riboside plus pterostilbene) in adults with knee osteoarthritis. Participants who qualify based on the screening will take 2 capsules twice daily for 12 weeks and complete questionnaires and a walking test to assess knee pain, physical function, and quality of life.
Blood and urine samples will also be collected to evaluate markers related to inflammation, NAD+, and cartilage health. The information collected may help researchers understand the potential effects of NRPT and guide future clinical trials.
- Conditions
- Knee Osteoarthristis
- Being tested
- NRPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRPTDietary supplement
EH301 is a higher-dose NRPT supplement containing nicotinamide riboside (NR) and pterostilbene (PT). Each capsule contains 250 mg of nicotinamide riboside and 50 mg of pterostilbene
| Study group | Role | What they receive |
|---|---|---|
| NRPT | Experimental | Participants will receive EH301 (NRPT), 4 capsules daily by mouth (2 capsules in the morning and 2 capsules in the evening), providing 1000 mg nicotinamide riboside plus 200 mg pterostilbene daily for 12 weeks. Receives: Dietary Supplement: NRPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to NRPT Supplement
Adherence to supplement will be evaluated based on percentage of dispensed capsules taken by pill count and self report, target is more than or equal to 85%
Measured: From Baseline (Week 0) through the End of Study visit (Week 12)
Participant Retention Rate
Retention will be assessed as the percentage of enrolled participants who complete the Week 12 study visit. The target retention rate is greater than or equal to 80%
Measured: From Baseline (Week 0) through completion of the End of Study visit (Week 12)
Participants recruitment rate
Recruitment rate will be assessed as the mean number of participants enrolled per month, with a 95% confidence interval
Measured: From the start of participant enrollment through completion of the recruitment period (approximately 18-24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants going to recieve the same intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Guma, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917403
- Sponsor's protocol ID
- 814610
- Acronym
- NRPT
- Status last verified
- Nov 2026
- First submitted
- 10 Oct 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label Pilot Study to Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07917403
- Acronym / sponsor ID
- NRPT / 814610
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis
Detailed description
This exploratory study will evaluate the feasibility, tolerability, and preliminary effects of NRPT (nicotinamide riboside plus pterostilbene) in adults with knee osteoarthritis. Participants who qualify based on the screening will take 2 capsules twice daily for 12 weeks and complete questionnaires and a walking test to assess knee pain, physical function, and quality of life.
Blood and urine samples will also be collected to evaluate markers related to inflammation, NAD+, and cartilage health. The information collected may help researchers understand the potential effects of NRPT and guide future clinical trials.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants going to recieve the same intervention
| Arm | Type | Receives |
|---|---|---|
| NRPT | Experimental | Dietary Supplement: NRPTParticipants will receive EH301 (NRPT), 4 capsules daily by mouth (2 capsules in the morning and 2 capsules in the evening), providing 1000 mg nicotinamide riboside plus 200 mg pterostilbene daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation.
- Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex.
- Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined from a standing knee radiograph obtained within the prior 12 months or at Screening.
- Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening.
Key exclusion criteria (11 listed)
- Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement).
- Severe radiographic knee disease (KL grade 4) in the index knee.
- Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees).
- Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal arthropathy of the index knee).
- Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other polyphenol-containing supplements (including resveratrol, curcumin) within the 3 months prior to Screening.
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 |
|---|---|---|
| NRPTEH301 is a higher-dose NRPT supplement containing nicotinamide riboside (NR) and pterostilbene (PT). Each capsule contains 250 mg of nicotinamide riboside and 50 mg of pterostilbene | Dietary supplement | NRPT |
Primary outcome
Adherence to NRPT Supplement
Time frame: From Baseline (Week 0) through the End of Study visit (Week 12)
Adherence to supplement will be evaluated based on percentage of dispensed capsules taken by pill count and self report, target is more than or equal to 85%
Participant Retention Rate
Time frame: From Baseline (Week 0) through completion of the End of Study visit (Week 12)
Retention will be assessed as the percentage of enrolled participants who complete the Week 12 study visit. The target retention rate is greater than or equal to 80%
Participants recruitment rate
Time frame: From the start of participant enrollment through completion of the recruitment period (approximately 18-24 months)
Recruitment rate will be assessed as the mean number of participants enrolled per month, with a 95% confidence interval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRPT in people with Knee Osteoarthristis, run by University of California, San Diego 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 9 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Guma, MD, Phd (8588226523, mguma@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to NRPT Supplement (time frame: From Baseline (Week 0) through the End of Study visit (Week 12)). The study lists 3 primary outcomes in all. 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 4 Nov 2026.