Effects of Products Containing <i>Bacillus subtilis</i> var. <i>natto</i> on Healthy Subjects with Neck and Shoulder Stiffness, a Double-Blind, Placebo-Controlled, Randomized Crossover Study

Abstract

Neck and shoulder stiffness is a typical subjective symptom in developed countries. This stiffness is caused by factors such as muscle tension and poor blood flow, leading to reduce work efficiency and diminish quality of life. NKCP ® , a natto-derived dietary food supplement whose main component is bacillopeptidase F, has antithrombotic, fibrinolytic, and blood viscosity-lowering effects. Here, we investigated the effect of NKCP ® on neck and shoulder stiffness in a double-blind placebo-controlled randomized crossover study.Thirty subjects with neck and shoulder stiffness were randomly divided into 2 groups and Biological and Pharmaceutical Bulletin Advance Publication IntroductionNeck and shoulder stiffness is a typical subjective symptom felt by people in developed countries when under physical strain. This stiffness is caused by factors such as increased use of visual display terminals (VDTs) to perform routine tasks, lack of exercise, and physical stress. These factors increase muscle tension and reduce blood flow around the neck and shoulders. [1][2][3][4] Because chronic neck and shoulder discomfort can lead to a decrease in work efficiency and diminished quality of life (QOL), the alleviation of this discomfort is highly desirable in developed countries.Natto is a traditional food made from fermented soybeans that has long been eaten in Japan. It has a balanced nutritional value and contains proteases that lower cholesterol, dissolve thrombi, and improve blood flow. Thus, it is an exceptional food that can help to improve public health. 5-7However, natto is sticky and highly pungent, so some individuals In the current study, we performed a double-blind cross-over study to examine the effects of NKCP ® on healthy subjects with neck and shoulder stiffness and pain. Material and Methods SubjectsThis study was approved by the clinical research ethics committees of the University The details of the study were explained to potential subjects verbally and in writing prior to the start of the study. Consent for study participation was obtained in writing.Inclusion criteria were subjects (men or women aged 20-80 years) with the physical symptoms of neck and shoulder stiffness and pain who routinely worked at a desk. Exclusion criteria were subjects with an underlying illness, pregnant or nursing, dementia, taking pharmaceuticals or supplements or consuming foods that might affect this study, and participating in other clinical studies. No specific restrictions were placed on receiving massages or on routinely applying a poultice to the neck and shoulders. Power analysisPower analysis was performed using G*Power 3.1.9.2 software. A previous Biological and Pharmaceutical Bulletin Advance Publicationcross-over study examined the effects of NKCP ® in 17 patients (dropout rate: 0%) with lifestyle-related diseases (Hitosugi et al, 2015). Based on the results of that study, a power analysis was performed with an effective dose of 0.5, a power of 0.7, and a significance level of 0.05. Assuming a dropout rate of ...

Dietary Patterns and Interventions to Alleviate Chronic Pain

“…In 2018, the effects of NKCP ® , a natto-derived dietary food supplement with bacillopeptidase F were tested in a double-blind, placebo-controlled, randomized crossover study performed for 4 weeks in 30 patients with neck and shoulder stiffness and headaches. The researchers showed an alleviation of headaches and chronic neck and shoulder stiffness and pain in these patients [79]. It is important to notice that no side effects were recorded.…”

“…Optimal combinations for increased efficacy to alleviate pain are pharmacological and nonpharmacological, diet being mentioned as an important tool for pain improvement [113,114]. The irritable bowel syndrome associated to fibromyalgia can be addressed by a gluten-free diet [59,61], as observed by Aman et al [115], while neck and shoulder stiffness responds to probiotics [79].…”

“…Of all pain categories defined most recently by the European Pain Federation [ 1 ], most trials referred to chronic musculoskeletal pain, i.e., low back pain (4 trials) [ 52 , 55 , 64 , 68 ], knee osteoarthritis in obese patients (3 trials) [ 44 , 46 , 74 ], fibromyalgia (7 trials) [ 45 , 47 , 56 , 59 , 61 , 62 , 78 ], neck pain and stiffness (1 trial) [ 79 ], musculoskeletal pain or peripheral neuropathy due to cancer treatment (3 trials) [ 64 , 69 , 70 ], chronic headache or migraine (6 trials) [ 43 , 48 , 49 , 51 , 66 , 67 ], generalized chronic musculoskeletal pain (2 trials) [ 54 , 72 ], diabetic neuropathy [ 50 , 71 ], taxol-induced neuropathic pain [ 63 ], or abdominal pain (10 trials) [ 53 , 57 , 58 , 60 , 65 , 71 , 73 , 75 , 76 , 77 , 80 ]. A synthesis is provided in Table 2 ( Table 2 ).…”

Thermography in complementary assessments of head and neck muscles: A scoping review

“…The following muscle regions were assessed: masseter, 14–17,19,21–23,25–27,29,30,32–34,36 temporal, 15–17,19,21–23,25–27,29–32,35,36 digastric, 19 buccinator, 35 frontalis, 32 orbicularis oris, 17,32 suprahyoid, 10 anterior cervical, 17,23 sternocleidomastoid, 15,19,23 trapezius 7–9,15,18,20,23,24,28 and levator scapulae 8,20,28 …”

“…Muscle parameters were quantitatively assessed, including acute muscle pain (with bioelectrical impedance assessment), 18 the amplitude of movements (with a flexometer), 9 muscle stiffness (with a PEK‐MP device) 20 and electrical activity (with surface electromyography) 9 . Only one study assessed blood flow velocity and peripheral circulation 20 …”