NMN clinical study

JRCT ID: jRCTs051190002

Registered date:03/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Physical Frailty
• Date of first enrollment: 04/04/2019
• Target sample size: 16
• Study type: Interventional
• Intervention(s): Oral administration of NMN 250mg or placebo per day for six months

Outcome(s)

• Primary Outcome: Change amount and change rate from baseline at the final evaluation of grip strength and walking speed

Secondary Outcome

Temporal change in the following items
1)Muscle Strength (Grip strength, Waking speed)
2)Muscle volume (Knee extension strength
3)Physical function (one leg standing duration with vision, five times rise time)
4)Muscle volume (measurement by body composition meter and skeletal muscle ultrasound echography)
5)Frality measurement (J-CHS scale)
6)Homed blood pressure and pulse rate measurement
7)Evalulation of diabetic condition and nephropathy(HbA1c, blood sugar, urinary microalbumin)
8)Evaluation of diabetic retinopathy (vision test, intraocular pressure measurement, fundus photo, optical coherence tomography angiography)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1)over 65 years of age
2)Decrease in grip (less than 26kg) and walking speed (less than 1m/sec)
3)Diabetes treatment or over HbA1c 6.5%

Exclude criteria

1)Decreased QOL
2)Malignant tumor
3)Dementia
4)Severe heart failure
5)Severe liver dysfunction, renal dysfunction, blood related diseases
6)Decreased nutrition
7)Worsened general condition by severe infections
8)Uncontrolled diabetes
9)Inappropriate patients for clinical study

Related Information

• Primary Sponsor: Rakugi Hiromi
• Secondary Sponsor: TEIJIN LIMITED