BioavailabilityPhase 215NRHCNCT02712593
A Study Investigating the Effects of Niagen™ in Healthy Adults.
A Phase 2 study testing Niagen™ 100, Niagen™ 300 and Niagen™ 1000 in people with Bioavailability, run by KGK Science Inc. at 1 site in Canada.
Trial summary
This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Niagen™ 100, Niagen™ 300 and Niagen™ 1000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 21 Mar 2016to Apr 2017
- Phase
- Phase 2
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-30kg/m²
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Non-hormonal intrauterine devices
- Vasectomy of partner
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- Healthy as determined by laboratory results, medical history, and physical exam
- Agrees to comply with study procedure
- Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).
- Agrees to refrain from consuming caffeine (i.e. coffee) on the days of study visits 3 to 7 (prior to the visit)
- Agrees to avoid taking Vitamin B3 (niacin, nicotinic acid,niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
- Has given voluntary, written, informed consent to participate in the study
- Agrees to avoid foods that contain high amounts of tryptophan and niacin and limit their ingestion of foods containing moderate amounts of tryptophan and niacin
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Alcohol use >2 standard alcoholic drinks per day
- History of alcohol or drug abuse within the past year
- Medicinal use of marijuana
- Diabetes (Type I or Type II)
- Subjects taking lipid lowering drugs
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- History of renal and/or liver disease
- History of pellagra or niacin deficiency
- Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, and neurological disorders including epilepsy, and recent cerebrovascular disease
- Subjects with or who had recently experienced a traumatic injury, inflammation, infections or had undergone surgery
- Use of natural health products containing NR within 14 days prior to randomization and during the course of the study
- Unstable medical conditions as determined by the Qualified Investigator
- Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) will be assessed by the Medical Investigator
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients
- Allergy or sensitivity to lidocaine
- Bleeding disorder
- Serum creatinine ≥ 130µmol/L for males and ≥ 125µmol/L for female
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or which may pose significant risk to the subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.
This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.
- Conditions
- Bioavailability
- Being tested
- Niagen™ 100, Niagen™ 300, Niagen™ 1000, Placebo
- Keywords
- Healthy participants, Dietary supplement, Bioavailability, Niagen™, Nicotinamide riboside, N-methylnicotinamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niagen™ 100Dietary supplement
Niagen™ 300Dietary supplement
Niagen™ 1000Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Niagen™ 100 | Experimental | Not described Receives: Dietary Supplement: Niagen™ 100 |
| Niagen™ 300 | Experimental | Not described Receives: Dietary Supplement: Niagen™ 300 |
| Niagen™ 1000 | Experimental | Not described Receives: Dietary Supplement: Niagen™ 1000 |
| Placebo | Experimental | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Methylnicotinamide
Change in levels
Measured: 8 weeks: from baseline to end of study
Secondary outcomes (3)
Blood Nicotinamide Riboside Metabolites
Change in levels
Measured: 8 weeks: from baseline to end of study
Urinary Nicotinamide Riboside Metabolites
Change in levels
Measured: 8 weeks: from baseline to end of study
Muscle Nicotinamide Riboside Metabolites
Change in Levels of Metabolites Assessed from Muscle Tissue collected with Micro-Needle Biopsy
Measured: 8 weeks: from baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start21 Mar 2016
- Primary completion17 Mar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ChromaDex, Inc.
- Responsible party
- Sponsor
- Investigators
- Gordon Schacter, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712593
- Sponsor's protocol ID
- 15NRHC
- Acronym
- 15NRHC
- Status last verified
- Apr 2018
- First submitted
- 1 Mar 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Parallel Study Investigating the Effects of Niagen™ (Nicotinamide Riboside) on Niagen™ Metabolites in Healthy Adults.
- ClinicalTrials.gov ID
- NCT02712593
- Acronym / sponsor ID
- 15NRHC / 15NRHC
- Conditions
- Bioavailability
- Keywords
- Healthy participants, Dietary supplement, Bioavailability, Niagen™, Nicotinamide riboside, N-methylnicotinamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- ChromaDex, Inc.
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
This study will evaluate the effect of repeated doses of Niagen™ on Niagen™ metabolite concentrations in blood, urine and muscle. There will be 3 doses of Niagen™ compared to a placebo. One quarter of subjects will receive the low dose of Niagen™, one quarter will receive the moderate dose of Niagen™, one quarter will receive the higher dose of Niagen™ and one quarter will reveive the placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Niagen™ 100 | Experimental | Dietary Supplement: Niagen™ 100 |
| Niagen™ 300 | Experimental | Dietary Supplement: Niagen™ 300 |
| Niagen™ 1000 | Experimental | Dietary Supplement: Niagen™ 1000 |
| Placebo | Experimental | Other: Placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- BMI 25-30kg/m²
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Healthy as determined by laboratory results, medical history, and physical exam
- Agrees to comply with study procedure
- Agrees to maintain current level of physical activity throughout the study and avoid exercising on the day of study visits 3 to 7 (prior to the visit).
Key exclusion criteria (21 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Alcohol use >2 standard alcoholic drinks per day
- History of alcohol or drug abuse within the past year
- Medicinal use of marijuana
- Diabetes (Type I or Type II)
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 |
|---|---|---|
| Niagen™ 100 | Dietary supplement | Niagen™ 100 |
| Niagen™ 300 | Dietary supplement | Niagen™ 300 |
| Niagen™ 1000 | Dietary supplement | Niagen™ 1000 |
| Placebo | Other | Placebo |
Primary outcome
Urinary Methylnicotinamide
Time frame: 8 weeks: from baseline to end of study
Change in levels
3 secondary outcomes
Blood Nicotinamide Riboside Metabolites
Time frame: 8 weeks: from baseline to end of study
Urinary Nicotinamide Riboside Metabolites
Time frame: 8 weeks: from baseline to end of study
Muscle Nicotinamide Riboside Metabolites
Time frame: 8 weeks: from baseline to end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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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.
Gordon Schacter, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niagen™ 100, Niagen™ 300 and Niagen™ 1000 in people with Bioavailability, run by KGK Science Inc. at 1 site in Canada.
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 13 inclusion and 21 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: finished, as of the sponsor's last update on 11 Apr 2018. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Methylnicotinamide (time frame: 8 weeks: from baseline to end of study). 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 11 Apr 2018.