NMN CLINICAL TRIALS (IN HUMANS)

 

Above is a comprehensive list of human trials for NMN to date.  The pace of human trials has picked up considerably over the past year or more.

Details of each study, including date, participants, duration, dosage, safety and efficacy

17 – Fingerstick blood assay maps real-world NAD+ disparity across gender and age

Date: August 2023
Participants: Three groups of subjects, 25 in each group, between 55 and 70 years of age
Type: double-blind, one placebo group and two treatment groups using different dosages of NMN
Duration: 30 days
Dosage: 500 mg/day and 1000 mg/day
Results:

“We showed that oral NMN supplementation and aerobic sport can significantly increase whole-blood NAD+ levels.” (15)

“The recorded average whole blood NAD+ level was 23.8 ± 5.5 μM in the placebo group, 41.7 ± 13.0 μM in the 500 mg/day group, and 58.8 ± 21.1 μM in the 1000 mg/day group” (15)

“aerobic sport and NMN supplementation increased whole-blood NAD+” (15)

16 – Nicotinamide mononucleotide (NMN) intake increases plasma NMN and insulin levels in healthy subjectsNicotinamide adenine dinucleotide metabolism and arterial stiffness after long-term nicotinamide mononucleotide supplementation: a randomized, double-blind, placebo-controlled trial

Date: August 2023
Participants: Eleven healthy participants (20–65 years old, males = 7, females = 4)
Type: Study conducted in accordance with the Declaration of Helsinki guidelines
Duration: 3 months
Dosage: 250mg NMN daily
Results:

“Oral administration of NMN increased the plasma concentrations of NMN and NAD+, and the postprandial serum insulin levels. The elevation levels of NMN and insulin varied widely among individuals. No adverse symptoms were observed in the participants.”

15 – Nicotinamide adenine dinucleotide metabolism and arterial stiffness after long-term nicotinamide mononucleotide supplementation: a randomized, double-blind, placebo-controlled trial

Date: February 2023
Participants: 36 healthy middle-aged participants
Type: Randomized, double-blind, placebo-controlled, parallel-group clinical trial
Duration: 12 weeks
Dosage: 125mg NMN or placebo twice daily
Abstract:

“Many animal studies have shown that oral administration of the nicotinamide adenine dinucleotide (NAD+) precursor nicotinamide mononucleotide (NMN) prevents the reduction of NAD+ levels in organs and tissues, helping alleviate aging-related diseases. However, there are very few clinical reports of NMN supplementation in humans. Thus, this study aimed to investigate the influence of a 12-week NMN oral supplementation on biochemical and metabolic health parameters. A 12-week randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted. A total of 36 healthy middle-aged participants received one capsule of either 125 mg NMN or placebo twice a day. Among the NAD+ metabolites, the levels of nicotinamide in the serum were significantly higher in the NMN intake group than in the placebo group. Pulse wave velocity values indicating arterial stiffness tended to decrease in the NMN intake group. However, no significant difference was found between the two groups. Long-term NMN supplementation at 250 mg/day was well tolerated and did not cause adverse events. NMN safely and effectively elevated NAD+ metabolism in healthy middle-aged adults. Additionally, NMN supplementation showed potential in alleviating arterial stiffness.”

14 – Nicotinamide Adenine Dinucleotide Augmentation in Overweight or Obese Middle-Aged and Older Adults: A Physiologic Study

Date: February 2023
Participants: Thirty overweight or obese adults, ≥ 45 years
Type: single-center, randomized, double-blind, placebo-controlled, parallel group, physiologic study
Duration: 28 days
Dosage: 2 NMN tablets each containing 500 mg twice daily
Conclusions:

“MIB-626 administration in overweight or obese, middle-aged and older adults safely increased circulating NAD levels, and significantly reduced total LDL and non-HDL cholesterol, body weight, and diastolic blood pressure. These data provide the rationale for larger trials to assess the efficacy of NAD augmentation in improving cardiometabolic outcomes in older adults.”

13 – The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial

Date: December 2022
Participants: 80 middle-aged healthy adults
Type: randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial
Duration: 60 days
Dosage: once daily oral dosing of placebo, 300 mg, 600 mg, or 900 mg NMN
Discussion:

“It was reported that NMN supplementation in aged mice increased NAD concentrations and improved physical activity [1], and increased treadmill running distance significantly by activating SIRT1 in skeletal muscle vascular endothelial cells [6]. When compared to placebo, our six-minute walking test results showed an increase of distances covered during the 6 min for all three NMN doses and the two time points except the 300 mg group at day 30, which is consistent with other published human clinical trials that NMN supplementation can increase skeletal muscle metabolization function [10], muscle strength [13], muscle utilization of oxygen [16], and lower limb function [17]. However, one trial reported that there was no statistically significant difference in its six-minute walking test when compared to placebo [11]. Finally, the results of our six-minute walking test are right within the published range of 294-691 m of healthy Indian adults considering all our trial participants are Indian ethnicity [22].

Our trial found that NMN supplementation helped maintain the blood biological age while it increased significantly in placebo during the 60-day trial.”

12 – Effects of nicotinamide mononucleotide on older patients with diabetes and impaired physical performance: A prospective, placebo-controlled, double-blind study

Date: November 2022
Participants: 14 male patients with diabetes aged ≥65 years with reduced grip strength (<26 kg) or walking speed (<1.0 m/s)
Type: placebo-controlled, double-blinded study
Duration: 24 weeks
Dosage: 250mg NMN per day
Results:

“We studied 14 participants aged 81.1 ± 6.4 years. NMN was tolerable without any severe adverse events. The changes in grip strength and walking speed showed no difference between the two groups: 1.25 kg (95% confidence interval -2.31 to 4.81) and 0.033 m/s (-0.021 to 0.087) in the NMN group, and -0.44 kg (-4.15 to 3.26) and 0.014 m/s (-0.16 to -0.13) in the placebo group, respectively. There were no significant differences in any exploratory indicators between the two groups. However, improved prevalence of frailty in the NMN group (P = 0.066) and different changes in central retinal thickness between the two groups (P = 0.051) was observed.”

11 – Nicotinamide Mononucleotide Is Safely Metabolized and Significantly Reduces Blood Triglyceride Levels in Healthy Individuals

Date: Sept 2022
Model: ten healthy individuals (age 20-70 years)
Duration: 1 day
Dosage: Intravenous injection of 300 mg of NMN
Results:

“A single injection of NMN reduces blood fat content by about 75%.” (12)

“NMN injections are safely metabolized and cause no discernible damage to the heart, kidney, or pancreas despite bypassing the body’s detoxifier – the liver.” (12)

“The injections boost blood NAD+ levels by about 20%.” (12)

10 – Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women

Date: Aug 2022
Participants: 31 healthy adult men and women aged 20-65 years old
Type: randomized, double-blind, placebo-controlled, parallel-group
Duration: 4 weeks
Dosage: 1250 mg of NMN administered orally once daily
Results:

“Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses. Moreover, no severe adverse events were observed during the study period.” (11)

“Our results indicate that β-NMN is safe and well-tolerated in healthy adult men and women in oral dose of 1250 mg once daily for up to 4 weeks.” (11)

9 – Clinical evaluation of changes in biomarkers by oral intake of NMN

Date: June 2022
Model: Postmenopausal women between 50 and 80 years old
Duration: 12 weeks
Dosage: 300 mg/day of oral NMN
Results:

“Supplementing older women with 300 mg of oral NMN improves sugar and cholesterol metabolism.” (9a)

“NMN improves hormone levels as measured by the “mother hormone” – dehydroepiandrosterone sulfate (DHEA-s).” (9a)

“Treatment with NMN reduces a process called glycation in the skin.” (9a)

8 – Chronic nicotinamide mononucleotide supplementation elevates blood nicotinamide adenine dinucleotide levels and alters muscle function in healthy older men

Date: May 2022
Model: Men aged 65 years and older
Duration: 12 weeks
Dosage: 250 mg per day of oral NMN
Abstract:

“Preclinical studies have revealed that the elevation of nicotinamide adenine dinucleotide (NAD +) upon the administration of nicotinamide mononucleotide (NMN), an NAD + precursor, can mitigate aging-related disorders; however, human data on this are limited. We investigated whether the chronic oral supplementation of NMN can elevate blood NAD + levels and alter physiological dysfunctions in healthy older participants. We administered 250 mg NMN per day to aged men for 6 or 12 weeks in a placebo-controlled, randomized, double-blind, parallel-group trial. Chronic NMN supplementation was well tolerated and caused no significant deleterious effect. Metabolomic analysis of whole blood samples demonstrated that oral NMN supplementation significantly increased the NAD + and NAD + metabolite concentrations. There were nominally significant improvements in gait speed and performance in the left grip test, which should be validated in larger studies; however, NMN exerted no significant effect on body composition. Therefore, chronic oral NMN supplementation can be an efficient NAD + booster for preventing aging-related muscle dysfunctions in humans.”

7 – A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults

Date: May 2022
Participants: 66 adult and elderly subjects
Type: Multicentre, randomised, double blind, placebo controlled
Duration: 60 days
Dosage: 2 capsules of 150mg NMN or starch powder per day
Results:

“At day 30, NAD+/NADH levels in the serum showed a noteworthy increase, i.e., by 11.3%, whereas the placebo group had shown no change at all. At the end of the study, i.e., day 60, the NAD+/NADH levels were increased further by 38% compared to baseline, against a mere 14.3% in the placebo group. In the case of SF 36, at day 60, the Uthever group showed a rise of 6.5%, whereas the placebo group was merely raised by 3.4%. At the end of the study, the mean HOMA IR Index showed a rise of 0.6% among the Uthever group and 30.6% among the Placebo group from baseline.”

6 – Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women

Date: April 2022
Model: prediabetic women between the ages of 55 and 75 who were overweight
Type: randomized, placebo-controlled, double-blind trial
Duration: 10 weeks
Dosage: 250 mg capsules/day of oral NMN
Results:

“This clinical study is the first to report the effectiveness of NMN on human health.” (6a)

“NMN supplementation up-regulated the expression of platelet-derived growth factor receptor β and other genes related to muscle remodeling.” (6a)

“The researchers show that NMN increases blood cell NAD+ levels and improves muscle insulin sensitivity and structure in aged, prediabetic women.” (6a)

5 – Oral Administration of Nicotinamide Mononucleotide Is Safe and Efficiently Increases Blood Nicotinamide Adenine Dinucleotide Levels in Healthy Subjects

Date:  April 2022
Participants:  thirty healthy subjects
Type:  placebo-controlled, randomized, double blind, parallel-group trial
Duration: 12 weeks
Dosage:  250 mg/day of NMN (n = 15) or placebo (n = 15)
Results:

“Healthy human subjects who took two 125 mg doses of NMN per day for 12 weeks nearly doubled their whole blood nicotinamide adenine dinucleotide (NAD) levels” (5a)

“No adverse physiological side effects, such as altered body weight or elevated blood pressure, were observed following NMN supplementation.” (5a)

“Whole blood NAD+ levels plateaued after four weeks of NMN usage and persisted for the 12-week duration of the study.” (5a)

4 – Effect of 12-Week Intake of Nicotinamide Mononucleotide on Sleep Quality, Fatigue, and Physical Performance in Older Japanese Adults: A Randomized, Double-Blind Placebo-Controlled Study

Date: Feb 2022
Participants: 108 participants divided into four groups (NMN_AM; antemeridian, NMN_PM; post meridian, Placebo_AM, Placebo_PM)
Type: Randomized, double-blind placebo-controlled study
Duration: 12 weeks
Dosage: 250mg/day or placebo
Abstract:

“Deteriorating sleep quality and physical or mental fatigue in older adults leads to decreased quality of life and increased mortality rates. This study investigated the effects of the time-dependent intake of nicotinamide mononucleotide (NMN) on sleep quality, fatigue, and physical performance in older adults. This randomized, double-blind placebo-controlled study evaluated 108 participants divided into four groups (NMN_AM; antemeridian, NMN_PM; post meridian, Placebo_AM, Placebo_PM). NMN (250 mg) or placebo was administered once a day for 12 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index. Fatigue was evaluated using the “Jikaku-sho shirabe” questionnaire. Grip strength, 5-times sit-to-stand (5-STS), timed up and go, and 5-m habitual walk were evaluated to assess the physical performance. Significant interactions were observed between 5-STS and drowsiness. 5-STS of all groups on post-intervention and drowsiness of the NMN_PM and Placebo_PM groups on mid- and post-intervention showed significant improvement compared with those in pre-intervention. The NMN_PM group demonstrated the largest effect size for 5-STS (d = 0.72) and drowsiness (d = 0.64). Overall, NMN intake in the afternoon effectively improved lower limb function and reduced drowsiness in older adults. These findings suggest the potential of NMN in preventing loss of physical performance and improving fatigue in older adults.”

3 – MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-aged and Older Adults

Date: Feb 2022
Participants: 32 overweight or obese adults, 55-80 years
Type: double-blind, placebo-controlled study
Duration: 14 days
Dosage: 1000-mg MIB-626 NMN once daily, twice daily, or placebo
Results:

“MIB-626 is a pharmaceutical-grade tablet of NMN from Metro International Biotech.” (3a)

“This study evaluated the ability of varying oral MIB-626 doses to raise intracellular NAD+ levels.” (3a)

“Two 500 mg MIB-626 tablets taken once or twice daily for two weeks doubled NAD+ blood levels in the participants middle-aged and older adults.” (3a)

2 – Nicotinamide mononucleotide supplementation enhances aerobic capacity in amateur runners: a randomized, double-blind study

Date: July 2021
Participants: 48 young and middle-aged recreationally trained runners
Type: Randomized, double-blind placebo-controlled four-arm clinical trial
Duration: 6 weeks
Dosage: participants were randomized into four groups: the low dosage group (300 mg/day NMN), the medium dosage group (600 mg/day NMN), the high dosage group (1200 mg/day NMN), and the control group (placebo)
Results:

“In middle-aged runners, supplementing 600 to 1200 mg/day of NMN for six weeks increases the aerobic capacity of humans during exercise training, and the improvement is likely the result of enhanced O2 utilization of the skeletal muscle.” (2a)

“The muscle oxygen utilization improvements increased with higher NMN doses during endurance exercise.” (2a)

“No adverse health effects while taking up to 1200 mg/day of NMN for six weeks were reported.” (2a)

1 – Effect of oral administration of nicotinamide mononucleotide on clinical parameters and nicotinamide metabolite levels in healthy Japanese men

Date: Feb 2020
Participants: 10 healthy men
Type: single-arm non-randomized
Duration: 5 hours
Dosage: single oral administration of 100, 250, and 500 mg NMN
Abstract:

“Recent studies have revealed that decline in cellular nicotinamide adenine dinucleotide (NAD+) levels causes aging-related disorders and therapeutic approaches increasing cellular NAD+ prevent these disorders in animal models. The administration of nicotinamide mononucleotide (NMN) has been shown to mitigate aging-related dysfunctions. However, the safety of NMN in humans have remained unclear. We, therefore, conducted a clinical trial to investigate the safety of single NMN administration in 10 healthy men. A single-arm non-randomized intervention was conducted by single oral administration of 100, 250, and 500 mg NMN. Clinical findings and parameters, and the pharmacokinetics of NMN metabolites were investigated for 5 h after each intervention. Ophthalmic examination and sleep quality assessment were also conducted before and after the intervention. The single oral administrations of NMN did not cause any significant clinical symptoms or changes in heart rate, blood pressure, oxygen saturation, and body temperature. Laboratory analysis results did not show significant changes, except for increases in serum bilirubin levels and decreases in serum creatinine, chloride, and blood glucose levels within the normal ranges, independent of the dose of NMN. Results of ophthalmic examination and sleep quality score showed no differences before and after the intervention. Plasma concentrations of N-methyl-2-pyridone-5-carboxamide and N-methyl-4-pyridone-5-carboxamide were significantly increased dose-dependently by NMN administration. The single oral administration of NMN was safe and effectively metabolized in healthy men without causing any significant deleterious effects. Thus, the oral administration of NMN was found to be feasible, implicating a potential therapeutic strategy to mitigate aging-related disorders in humans.”

References:

1 – Effect of oral administration of nicotinamide mononucleotide on clinical parameters and nicotinamide metabolite levels in healthy Japanese men

1a – Clinical Trial Shows Safety of NMN in Humans

2 – Nicotinamide mononucleotide supplementation enhances aerobic capacity in amateur runners: a randomized, double-blind study

2a – Human Trial Shows NMN Enhances Exercise Endurance in Runners

3 – MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-aged and Older Adults

3a – Metro Biotech Publishes MIB-626 NMN Human Data

4 – Effect of 12-Week Intake of Nicotinamide Mononucleotide on Sleep Quality, Fatigue, and Physical Performance in Older Japanese Adults: A Randomized, Double-Blind Placebo-Controlled Study

5 – Oral Administration of Nicotinamide Mononucleotide Is Safe and Efficiently Increases Blood Nicotinamide Adenine Dinucleotide Levels in Healthy Subjects

5a – Clinical Study Indicates that NMN Efficaciously Increases Blood NAD+ in Humans

6 – Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women

6a – Metabolic Benefits of NMN Shown for First Time in Humans

7 – A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults

8 – Chronic nicotinamide mononucleotide supplementation elevates blood nicotinamide adenine dinucleotide levels and alters muscle function in healthy older men

9 – Clinical evaluation of changes in biomarkers by oral intake of NMN (PDF)

9a – Japanese Study Indicates NMN Reverses Signs of Aging in Older Women

10 – Nicotinamide adenine dinucleotide metabolism and arterial stiffness after long-term nicotinamide mononucleotide supplementation: a randomized, double-blind, placebo-controlled trial

11 – Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women

12 – Japanese Study Indicates NMN Injections Reduce Blood Fat Content in Healthy Individuals

12a – Nicotinamide Mononucleotide Is Safely Metabolized and Significantly Reduces Blood Triglyceride Levels in Healthy Individuals

13 – Effects of nicotinamide mononucleotide on older patients with diabetes and impaired physical performance: A prospective, placebo-controlled, double-blind study

14 – The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial

15 – Fingerstick blood assay maps real-world NAD+ disparity across gender and age