Glucose Metabolism DisordersNMNNCT03151239
Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function
A study testing NMN supplement in people with Glucose Metabolism Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- NMN supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jun 2021
- 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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women 55-75 years old
- BMI 25.0-44.9 kg/m²
- Fasting plasma glucose concentration ≥100 mg/dl, OGTT 2 hour glucose ≥ 140 mg/dl, HbA1C ≥5.7%, or HOMA-IR ≥2.5
Who cannot join
- Diabetes
- Premenopausal or menopause <1 year
- Persons who have received hormone replacement therapy within the past 6 months
- Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
- Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min/wk of low intensity physical activity (e.g., brisk walking).
- Unstable weight (>3% change during the last 2 months before entering the study)
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- Significant organ system dysfunction or disease
- Present cancer or history of cancer that has been in remission for <5 years
- Polycystic ovary syndrome
- Major psychiatric illness
- Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study
- Metal implants
- Smokes cigarettes
- Persons who consume >14 units of alcohol per week
- Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.
Read the detailed description
This study is is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease. Accordingly, the investigators will evaluate the effect of NMN on how well the hormone insulin works to control blood sugar. The investigators will also look at the effects of NMN on blood lipids; body fat and liver fat; and other blood, fat tissue and muscle tissue markers of cardiovascular (heart) and metabolic health. Data from studies conducted in rodents have shown that NMN supplementation has beneficial effects on cardiovascular and metabolic health, but this has not yet been studied in people.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- NMN supplement, Placebo
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMN supplementDietary supplement
Also called nicotinamide mononucleotide
Intervention will last at least 8 weeks in the form of two capsules (250 mg total).
PlaceboOther
Intervention will last at least 8 weeks in the form of two capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| NMN supplementation | Experimental | Not described Receives: Dietary Supplement: NMN supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle insulin sensitivity
The outcome will be assessed by hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Secondary outcomes (12)
Changes in liver insulin sensitivity
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Change in adipose tissue insulin sensitivity
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Change in body fat mass
The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Change in fat free mass
The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in intra-abdominal adipose tissue volume
The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in intrahepatic triglyceride content
The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in blood pressure
The outcome will be assessed by measuring blood pressure at rest before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in plasma glucose concentration
The outcome will be determined by plasma glucose concentration after overnight fasting, before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in fasting insulin
The outcome will be determined by plasma insulin concentration after overnight fasting, before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in fasting free fatty acid
The outcome will be determined by plasma free fatty acid concentration after overnight fasting, before and after intervention period.
Measured: before and after at least 8 weeks of treatment
Changes in tissue NAD content
The outcome will be assessed by measuring NAD content before and after intervention period
Measured: before and after at least 8 weeks of treatment
Changes in protein levels in skeletal muscle insulin signaling
The outcome will be determined by Western blot by using samples collected before and after intervention period
Measured: before and after at least 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Jul 2017
- Primary completion30 May 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151239
- Sponsor's protocol ID
- 201701096
- Acronym
- NMN
- Status last verified
- Jul 2021
- First submitted
- 8 May 2017
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, Sindelar M, Pietka T, Patterson BW, Imai SI, Klein S. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021 Jun 11;372(6547):1224-1229. doi: 10.1126/science.abe9985. Epub 2021 Apr 22.
PubMed 33888596
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
- ClinicalTrials.gov ID
- NCT03151239
- Acronym / sponsor ID
- NMN / 201701096
- Conditions
- Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 May 2017 (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 the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.
Detailed description
This study is is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease. Accordingly, the investigators will evaluate the effect of NMN on how well the hormone insulin works to control blood sugar. The investigators will also look at the effects of NMN on blood lipids; body fat and liver fat; and other blood, fat tissue and muscle tissue markers of cardiovascular (heart) and metabolic health. Data from studies conducted in rodents have shown that NMN supplementation has beneficial effects on cardiovascular and metabolic health, but this has not yet been studied in people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| NMN supplementation | Experimental | Dietary Supplement: NMN supplement |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women 55-75 years old
- BMI 25.0-44.9 kg/m²
- Fasting plasma glucose concentration ≥100 mg/dl, OGTT 2 hour glucose ≥ 140 mg/dl, HbA1C ≥5.7%, or HOMA-IR ≥2.5
Key exclusion criteria (15 listed)
- Diabetes
- Premenopausal or menopause <1 year
- Persons who have received hormone replacement therapy within the past 6 months
- Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
- Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min/wk of low intensity physical activity (e.g., brisk walking).
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 |
|---|---|---|
| NMN supplementAlso: nicotinamide mononucleotideIntervention will last at least 8 weeks in the form of two capsules (250 mg total). | Dietary supplement | NMN supplementation |
| PlaceboIntervention will last at least 8 weeks in the form of two capsules. | Other | Placebo |
Primary outcome
Change in muscle insulin sensitivity
Time frame: before and after at least 8 weeks of treatment
The outcome will be assessed by hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
12 secondary outcomes
Changes in liver insulin sensitivity
Time frame: before and after at least 8 weeks of treatment
Change in adipose tissue insulin sensitivity
Time frame: before and after at least 8 weeks of treatment
Change in body fat mass
Time frame: before and after at least 8 weeks of treatment
Change in fat free mass
Time frame: before and after at least 8 weeks of treatment
Changes in intra-abdominal adipose tissue volume
Time frame: before and after at least 8 weeks of treatment
Changes in intrahepatic triglyceride content
Time frame: before and after at least 8 weeks of treatment
Changes in blood pressure
Time frame: before and after at least 8 weeks of treatment
Changes in plasma glucose concentration
Time frame: before and after at least 8 weeks of treatment
Changes in fasting insulin
Time frame: before and after at least 8 weeks of treatment
Changes in fasting free fatty acid
Time frame: before and after at least 8 weeks of treatment
Changes in tissue NAD content
Time frame: before and after at least 8 weeks of treatment
Changes in protein levels in skeletal muscle insulin signaling
Time frame: before and after at least 8 weeks of treatment
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 14 Jul 2021.
- Derived from this study: PubMed 33888596Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, Sindelar M, Pietka T, Patterson BW, Imai SI, Klein S. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021 Jun 11;372(6547):1224-1229. doi: 10.1126/science.abe9985. Epub 2021 Apr 22.
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMN supplement in people with Glucose Metabolism Disorders, run by Washington University School of Medicine 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 3 inclusion and 15 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 14 Jul 2021. 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?
Change in muscle insulin sensitivity (time frame: before and after at least 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151239, which also lists 1 linked publication.
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 14 Jul 2021.