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

Yoichi Sunagawa, Nobuko Okamura, Yusuke Miyazaki, Kana Shimizu, Mai Genpei, Masafumi Funamoto, Satoshi Shimizu, Yasufumi Katanasaka, Eriko Morimoto, Hajime Yamakage, Maki Komiyama, Noriko Satoh-Asahara, Hiromichi Wada, Mika Suzuki, Koji Hasegawa, Tatsuya Morimoto

Journal: Biological & pharmaceutical bulletin 2018;41(4):504-509

PMID: 29415906

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Neck and shoulder stiffness and pain are common complaints, and causative factors include muscle tension and reduced blood flow around the neck and shoulders. NKCP® is as a food supplement that contains bacillopeptidase F, a protease (enzyme) that is isolated and purified from the culture of the probiotic bacterium B. subtilis var. natto, which is used to ferment soy beans to natto, a traditional Japanese food. Various health benefits have been attributed to natto, and NKCP® has been shown to have blood thinning properties. This double-blind, placebo controlled crossover study aimed to evaluate the effects of NKCP® on healthy individuals with neck and shoulder stiffness and pain. Subjects received either NKCP® or placebo for 4 weeks, then had a 4 week washout period where they received neither test supplement, and then received the other test supplement for another 4 weeks. Shoulder and neck symptoms were assessed prior to starting the trial, and at 4, 8 and 12 weeks, through subjective reporting and a muscle hardness meter to measure muscle stiffness. Neck and shoulder stiffness and pain were improved after taking NKCP® but not significantly more than in the placebo group. Headaches improved significantly more in the NKCP® group compared to the placebo group. No significant changes were observed for lower back pain, cold hands and feet, eyestrain, and dry eye.

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 QOL. 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 ingested 250 mg of NKCP or placebo daily for 4 weeks. Headache score significantly improved in the NKCP group compared to the placebo group. Moreover, NKCP significantly improved the score of visual analogue scale for neck and shoulder stiffness and pain, reduced muscle stiffness of the neck, and increased the skin surface temperature of neck and shoulders, compared to before ingestion. No adverse effects were observed during this study. These results suggest that NKCP may alleviate headaches and chronic neck and shoulder stiffness and pain.

Address: Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka.; Division of Translational Research, Clinical Research Institute, Kyoto Medical Center, National Hospital Organization.; Shizuoka General Hospital.; Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka.; Division of Molecular Medicine, School of Pharmaceutical Sciences, University of Shizuoka.; Division of Translational Research, Clinical Research Institute, Kyoto Medical Center, National Hospital Organization.; Shizuoka General Hospital.; Division of Diabetic Research, Clinical Research Institute, Kyoto Medical Center, National Hospital Organization.; Division of Translational Research, Clinical Research Institute, Kyoto Medical Center, National Hospital Organization.; Seirei Healthcare Support Center Shizuoka.

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