Trial · Interventional

CompletedNot applicableRegistry data

Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function

Short name NMN

NCTNCT03151239Other id201701096

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 25 participants (actual)
Sponsor: Washington University School of Medicine · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 1 Jul 2017
Primary completion: 30 May 2019
Completion: 30 Jun 2021
First posted: 12 May 2017
Last update posted: 14 Jul 2021
Conditions: Glucose Metabolism Disorders

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019202020212022

N/A
NMN
NCT03151239
1 Jul 2017 to 30 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.

Interventions

NMN supplementDietary supplement
PlaceboOther

Arms2

Placebo comparator
Placebo
Experimental
NMN supplementation

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in muscle insulin sensitivity
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be assessed by hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.

Secondary outcomes(12)

Changes in liver insulin sensitivity
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Change in adipose tissue insulin sensitivity
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Change in body fat mass
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.
Change in fat free mass
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.
Changes in intra-abdominal adipose tissue volume
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Changes in intrahepatic triglyceride content
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Changes in blood pressure
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be assessed by measuring blood pressure at rest before and after intervention period.
Changes in plasma glucose concentration
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be determined by plasma glucose concentration after overnight fasting, before and after intervention period.
Changes in fasting insulin
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be determined by plasma insulin concentration after overnight fasting, before and after intervention period.
Changes in fasting free fatty acid
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be determined by plasma free fatty acid concentration after overnight fasting, before and after intervention period.
Changes in tissue NAD content
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be assessed by measuring NAD content before and after intervention period
Changes in protein levels in skeletal muscle insulin signaling
Time frame · before and after at least 8 weeks of treatment
Registry description
The outcome will be determined by Western blot by using samples collected before and after intervention period

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women.

Yoshino et al. 2021Science (New York, N.Y.)cited by 362

PMID 33888596PMC8550608DOI 10.1126/science.abe9985PUB-33888596

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 55 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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.

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