AgingNCT03501433
Effects of Nicotinamide Riboside on Metabolism and Vascular Function
A study testing Nicotinamide riboside chloride (Niagen) in people with Aging and Lipemia, run by Iowa State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Nicotinamide riboside chloride (Niagen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Dec 2019
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 35 (young) and 60 to 75 (older)
- Normo- or pre-hypertensive (blood pressure <140/90 mmHg)
- Non-smokers
- Able to give informed consent and participate in all laboratory visits
Who cannot join
- Currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers)
- Known metabolic (e.g. Type I or Type II diabetes, cardiovascular disease, etc.) or immunologic (e.g. HIV, cancer, autoimmune, etc.) diseases
- Food allergies to egg, milk, soy or wheat
- Women who are pregnant or planning to become pregnant during the course of the study,
- Pacemaker or other implanted device
- Unwilling to participate in the experimental protocol or blood draws will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.
Read the detailed description
The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.
- Being tested
- Nicotinamide riboside chloride (Niagen), Placebo
- Keywords
- postpandial, lipemia, microvascular
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide riboside chloride (Niagen)Dietary supplement
Also called Nicotinamide Riboside, Niagen
250 mg capsules 2x/day for 7 days
PlaceboDietary supplement
2x/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside Chloride (Niagen) | Experimental | 7 days of nicotinamide riboside supplementation (250 mg/d x 2/day). Receives: Dietary Supplement: Nicotinamide riboside chloride (Niagen) |
| Placebo | Placebo comparator | 7 days of placebo supplementation (2/day) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAD+
Blood and peripheral blood mononuclear cell (PBMC) levels
Measured: 7 days
Secondary outcomes (3)
Vasodilatory responsiveness
Post-Occlusion Reactive Hyperemia (PORH)
Measured: 7 days
Lipdemia
Fasting and postprandial
Measured: 7 days
Oxidative stress and inflammation
Plasma markers and expression in circulating PBMCs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudy Valentine, Iowa State University
- Investigators
- Rudy Valentine, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501433
- Sponsor's protocol ID
- 17-603
- Status last verified
- Sep 2020
- First submitted
- 10 Apr 2018
- Last updated
- 25 Sep 2020
- Results posted
- 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 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotinamide Riboside on Metabolism and Vascular Function
- ClinicalTrials.gov ID
- NCT03501433
- Acronym / sponsor ID
- 17-603
- Keywords
- postpandial, lipemia, microvascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 18 Apr 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.
The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.
Detailed description
The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal. Differences between young (18-35) and older (60-75) adults will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, cross-over
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside Chloride (Niagen) | Experimental | Dietary Supplement: Nicotinamide riboside chloride (Niagen)7 days of nicotinamide riboside supplementation (250 mg/d x 2/day). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo7 days of placebo supplementation (2/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 35 (young) and 60 to 75 (older)
- Normo- or pre-hypertensive (blood pressure <140/90 mmHg)
- Non-smokers
- Able to give informed consent and participate in all laboratory visits
Key exclusion criteria (6 listed)
- Currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers)
- Known metabolic (e.g. Type I or Type II diabetes, cardiovascular disease, etc.) or immunologic (e.g. HIV, cancer, autoimmune, etc.) diseases
- Food allergies to egg, milk, soy or wheat
- Women who are pregnant or planning to become pregnant during the course of the study,
- Pacemaker or other implanted device
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 chloride (Niagen)Also: Nicotinamide Riboside, Niagen250 mg capsules 2x/day for 7 days | Dietary supplement | Nicotinamide Riboside Chloride (Niagen) |
| Placebo2x/day for 7 days | Dietary supplement | Placebo |
Primary outcome
NAD+
Time frame: 7 days
Blood and peripheral blood mononuclear cell (PBMC) levels
3 secondary outcomes
Vasodilatory responsiveness
Time frame: 7 days
Lipdemia
Time frame: 7 days
Oxidative stress and inflammation
Time frame: 7 days
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 25 Sep 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.
Rudy Valentine, PhD principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide riboside chloride (Niagen) in people with Aging and Lipemia, run by Iowa State University 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 4 inclusion and 6 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 25 Sep 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.
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?
NAD+ (time frame: 7 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 25 Sep 2020.