NMN口腔管理に関する臨床痕跡のコレクション

NMN, as one of NAD+ booster family critical members, become increasingly popular on the market in the filed of health pomoting. And to date, there are ten clinical trails about NMN intaking on humans totally.  And the very first trail lanched in 2020, which pioneered the  NMN clinical performance on humans. And the followings demonstrate 10 clinical trails of NMN oral intaking which are supposed to provide supporting materails for NMN commercial marketing.

No.1 ニコチンアミドモノヌクレオチドの経口投与が健康な日本人男性の臨床パラメータとニコチンアミド代謝産物レベルに及ぼす影響。

Date: 2020
Clinical Trail Institution: Clinical Trial Unit, Keio University School of Medicine, Japan.
Subjects: 10 healthy male subjects aged 40 to 60 years
Purpose: To investigate the safety of single NMN administration
Method: single-arm non-randomized intervention was conducted by single oral administration of 100, 250, and 500 mg NMN.
Findings: The single oral administration of NMN was safe and effectively metabolized in healthy men without causing any significant deleterious effects.
Conclusion: The oral administration of NMN was found to be feasible, implicating a potential therapeutic strategy to mitigate aging-related disorders in humans.

いいえ2。ニコチンアミドモノヌクレオチドは、糖尿病予備軍の女性の筋肉インスリン感受性を高めます

Date: 2021
Clinical Trail Institution: Center for Human Nutrition, Washington University School of Medicine, St. Louis, MO, USA
Subjects: 25 postmenopausal women with prediabetes who were overweight or obese
Purpose: To evaluate the effect of daily NMN supplement in people
Method: conducted a 10-week, randomized, placebo-controlled, double-blind trial,  subjects intake 250mg/day for 10 weeks
Findings: It demonstrates that NMN supplementation (250 mg/day) increases skeletal muscle insulin signaling, insulin sensitivity, and muscle remodeling in post-menopausal women with prediabetes who are overweight or obese.

いいえ3。ニコチンアミドモノヌクレオチド補給はアマチュアランナーの有酸素能力を高める:無作為化二重盲検試験

Date: 2021
Clinical Trail Institution: Key Laboratory of Exercise and Health Promotion of Guangzhou Sport University
Subjects: 48 young and middle-aged recreationally trained runners of the Guangzhou Pearl River running team
Purpose: To investigates the effects of a combination of exercise training and supplementation with nicotinamide mononucleotide (NMN), on cardiovascular fitness in healthy amateur runners.
Method: 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 (ten male participants and two female participants)
Findings: NMN increases the aerobic capacity of humans during exercise training, and the improvement is likely the result of enhanced O2 utilization of the skeletal muscle.
Conclusion: NMN as adjunct treatment may help to improve performance during exercise training. Exercise training combining with NMN supplementation may be a novel and practical strategy to increase endurance performance of athletes.

いいえ4。ニコチンアミドモノヌクレオチドの12週間摂取が日本人高齢者の睡眠の質、疲労、身体能力に及ぼす影響:無作為化二重盲検プラセボ対照試験

Date: 2022
Clinical Trail Institution: R&D Center for Tailor-Made QOL, University of Tsukuba
Subjects: 108 healthy Japanese old adults
Purpose: To clarify the effects of the time-dependent intake of NMN for 12 weeks on sleep quality, fatigue, and physical performance in Japanese older adults
Method: a randomized, double-blind, placebo-controlled parallel-group study, NMN (250mg) or placebo was administered once a day for 12 weeks.
Findings: NMN intake in the afternoon effectively improved lower limb function and reduced drowsiness in older adults O2 utilization of the skeletal muscle.
Conclusion: The practical potential of NMN in preventing loss of physical performance and improving fatigue in older adults.

いいえ5。中高年成人を対象とした経口投与サプリメントであるUthever(NMNサプリメント)の有効性と安全性を評価するための多施設無作為化二重盲検並行設計プラセボ対照試験

Date: 2022
Clinical Trail Institution: Swasthya clinic & research centre and Nirmaya hospital in Pune; Effepharm (Shanghai) Co., Ltd.,
Subjects: 66 healthy participants between the ages of 40 and 65 years
Purpose: To evaluate the anti-aging effect of NMN and its safety.
Method: a double-blind, parallel, randomized controlled clinical trial.  instructed to take two capsules (each containing 150 mg. of NMN or starch powder) once a day after breakfast for 60 days.
Findings: NMN was well tolerated up to 300 mg. The rise in the levels of NAD+/NADH at day 30 and day 60 illustrated the potential of NMN to raise the levels of NAD+ in the cells, which is linked to higher energy levels and an anti-aging effect. Increased sensitivity to insulin has also been linked to antiaging.

No.6ニコチンアミドモノヌクレオチドの経口投与は安全で、健康な被験者の血中ニコチンアミドアデニンジヌクレオチドレベルを効率的に増加させます

Date: 2022
Clinical Trail Institution: Clinical Research Review Board, University of Toyama
Subjects: 30 healthy Japanese volunteers between 20 and 65 years old
Purpose: To assess the safety of NMN. To assess the NAD+ related metabolites and amino acids in whole blood.
Method: A placebo-controlled, randomized, double blind, parallel-group trial.  received
250 mg/day of NMN (n = 15) or placebo (n = 15) for 12 weeks
Findings: Oral supplementation of NMN for 12 weeks caused no abnormalities in physiological and laboratory tests, and no obvious adverse effects were observed. NADC levels in whole blood were significantly increased after NMN administration.   
Conclusion: Oral administration of NMN is a safe and practical strategy to boost NAD+ levels in humans.

No.7慢性ニコチンアミドモノヌクレオチド補給は、健康な高齢男性の血中ニコチンアミドアデニンジヌクレオチドレベルを上昇させ、筋肉機能を変化させます

Date: 2022
Clinical Trail Institution: Clinical Research Support Center Phase 1 Unit at the University of Tokyo Hospital
Subjects: 42 men of age 65 years or more
Purpose: To explore whether the chronic oral supplementation of NMN can elevate blood NAD + levels and alter physiological dysfunctions in healthy older participants.
Method: a placebo-controlled, randomized, double-blind, parallel-group study with the administration of 250 mg of NMN to healthy men aged 65 years or more for 12 weeks.
Findings: 1. Supplementation of 250 mg/day NMN for 12 weeks is well tolerated. 2. Chronic oral administration of NMN increases the levels of NAD+ and NAD+-related metabolites in whole blood. 3. Chronic oral administration of NMN partly improves motor functions.  
Conclusion: The effects of NMN supplementation on physiological functions suggest NMN improves muscle strength, which is an important clinical indicator of aging. Chronic oral administration of NMN could be a therapeutic strategy for aging-related disorders in humans, such as sarcopenia.

No.8 MIB-626は、β-ニコチンアミドモノヌクレオチドの微結晶性特異多形の経口製剤であり、中高年成人におけるニコチンアミドアデニンジヌクレオチドとその代謝を増加させます

Date: 2022
Clinical Trail Institution: Metro Intl. Biotech, America.
Subjects: 32 overweight or obese adults, 55–80 years
Purpose: To explore the efficacy of NMN in empowering the NAD level on humans
Method: double-blind, placebo-controlled study, were block-randomized, stratified by sex, to 1 000-mg MIB-626 once daily, twice daily, or placebo for 14 days. NMN was measured using liquid chromatography–tandem mass spectrometry.
Findings: MIB-626(NMN) was well tolerated and frequency of adverse events was similar across groups. Blood NMN concentrations on Day 14 in MIB-626-treated groups were significantly higher compared to placebo MIB-626 treatment was associated with substantial dose-related increases in blood NAD levels. Blood levels of NAD metabolites were higher in NMN-treated participants on Days 8 and 14 than at baseline.  
Conclusion: MIB-626 1 000 mg once-daily or twice-daily regimens were safe and associated with substantial dose-related increases in blood NAD levels and its metabolome. Based on the foundational data, NMN should facilitate design of efficacy trials in disease conditions.

No.9 NMNの経口摂取によるバイオマーカー変化の臨床評価

Date: 2022
Clinical Trail Institution: Renais Clinic Nihonbashi, Tokyo, Japan
Subjects: 17 healthy postmenopausal women aged between 50 and 80 years (mean age 55.0 years)
Purpose: To investigate the changes in various biomarkers in humans after oral intake of NMN and evaluate its clinical significance.
Method: subjects received oral intake of 300 mg/day of pure NMN for 8 weeks.
Findings: NMN 300 mg/day orally for 8 weeks showed no safety issues and favorable changes in many biomarkers, suggesting that NMN, may be a promising nutritional material for aging and metabolic control in humans.
Conclusion: This study provided findings that may be useful in daily medical practice, such as changes in various biomarkers (i.e., blood biochemistry, glucose metabolism, lipid metabolism, hormones, and immunity) measured as clinical tests as well as safety, and bodily sensation.

No. 10 健康な中年成人におけるβ-ニコチンアミドモノヌクレオチド(NMN)補給の有効性と安全性:無作為化、多施設、二重盲検、プラセボ対照、並行群間、用量依存臨床試験

Date: 2022
Clinical Trail Institution: Lotus Healthcare and Aesthetics Clinic, and Sunad Ayurved (both in Pune, India),
Subjects: 80 40-65 years and healthy volunteers of both males and females
Purpose: To evaluate blood NAD concentration with dose-dependent regimens. To assess the safety and tolerability of NMN supplementation. To evaluate the clinical efficacy by measuring physical performance.
Method: subjects received oral intake of 300 mg/day of pure NMN for 8 weeks.
Findings: This trial showed that NMN supplementation is safe and well tolerated at up to 900 mg oral daily doses. There were no NMN treatment-related adverse events and dropouts. Lab parameters and physical examination did not show significant abnormal changes during the 60-day NMN treatments of all three doses.
Conclusion: Blood NAD concentration was significantly and dose-dependently increased during the NMN treatment. NMN supplementation had a positive impact on the physical endurance and general health conditions of healthy adults as demonstrated in the significant improvement of six-minute walking test, blood biological age, and SF-36 scores.

One of the most common endpoints of all the trails stands on the safety of orally intaking NMN for humans which can be confirmed. But owing to the different subjects and purposes of the trails, some of them also concluded the efficacies of NMN on the sides of anti-aging, muscle sigially and insulin sensitivity.