[Summary]The effect of improving the intestinal environment , body weight and body fat by ingesting foods containing butyricacid bacteria and propionic acid
<Improvement of intestinal environment>[Title] The effect of improving the intestinal environment by ingesting food containing Clostridium butyricum and3-(4-hydroxy-3-methoxyphenyl)propionic acid (hereinafter referred to as HMPA).
[Purpose] Targeting healthy Japanese men and women who defecate less than 5 days a week . The purpose of thisstudy was to verify whether the intestinal environment improved compared to the placebo.
[Background] In recent years, due to eating habits centered on meat, requests to refrain from going out, andpromotion of telework, we are living in a high-fat, low-fiber diet, lack of exercise, irregular lifestyles, and stressfulenvironments. In particular, the number of people who complain of constipation due to lack of vegetables and lackof exercise is increasing year by year, and one in two women is said to be constipated. Butyric acid, one of the shortchain fatty acids, is used as an energy source for the colonic epithelium and is essential for creating good intestinal
flora (intestinal flora). If it is possible to promote the production of short-chain fatty acids such as butyric acid in
the intestine, it will lead to the improvement of the intestinal flora (intestinal flora), and it is believed that it will
also lead to the improvement of bowel movements. Although there are reports on the intestinal environment andbowel movements caused by Clostridium butyricum and short-chain fatty acids, there are no reports on the effectsof combined use of Clostridium butyricum and HMPA.
[Method] Healthy men and women aged 20 to 59 years with a BMI of 23 or more and less than 30 were selected.
In order to confirm the effect of improving the environment and intestinal flora (intestinal flora), the test productintake group was given Clostridium butyricum at 14.0 mg/day (14 million cells/day) and HMPA derived fromfermented rice bran at 11.5 mg/day. mg/day for 12 weeks, and the placebo group did not receive this component.
A randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted withmetagenome analysis (transition of intestinal bacteria) and metabolome analysis (short-chain fatty acids) set as
endpoints, and defecation status was confirmed by recording. We also checked for side effects during the trial period.
This test was conducted by the submitter after requesting and providing funding to an external testing institution.
[Main results] After 8 weeks of intake , the test product group showed significant levels of Clostridium butyricum
and Coprococcus , a butyrate-producing bacterium, compared with the placebo group, and after 12 weeks of intake,
Clostridium butyricum . A significant increase was observed, as well as promotion of the production of butyric acidand acetic acid. In addition, a significant improvement was observed in the subjective evaluation of exhilaration ofbowel movements. There were no safety issues in this study.
<Improved body weight and body fat (visceral fat, subcutaneous fat)>[Title] The effects of intake of food containing Clostridium butyricum and HMPA on improving body weight andbody fat (visceral fat and subcutaneous fat).

[Purpose] Targeting healthy men and women aged 20 to 59 with a BMI of 23 or more and less than 30, andcontinuously ingesting Clostridium butyricum and HMPA-containing foods. The purpose of this study was to verify
whether the functionality of reducing body weight and body fat (visceral fat/subcutaneous fat) can be obtained
compared to the placebo.
[Background] Due to the epidemic of infectious diseases in recent years, the Ministry of Health, Labor and Welfare
has announced measures to prevent the spread of infection, such as requesting people to refrain from going outand promoting telework. Changes in people's lifestyles in such an environment have led to problems such as loss ofopportunities for exercise and uneven nutritional intake due to eating alone, resulting in an increase in the numberof people suffering from lack of exercise and weight gain. According to a questionnaire survey conducted on 350
teleworkers in May 2020, 40% of them are aware of the tendency to gain weight.
The short-chain fatty acids butyric acid, acetic acid, and propionic acid are said to have many physiological effects
that maintain health. It has been reported one after another that the intestinal flora metabolizes undigested foodcomponents, supplies nutritional components, and also participates in metabolic receptors, affecting lipid
metabolism and fat accumulation. In other words, if it is possible to promote the production of short-chain fatty
acids such as butyric acid in the intestine, it will lead to the improvement of the intestinal flora (intestinal flora),
and it will also lead to the improvement of lipid metabolism and fat accumulation. . Although there are reports on
the metabolism of Clostridium butyricum , short-chain fatty acids, and HMPA itself regarding the improvement oflipid metabolism and fat accumulation , there are no reports on the effects of combined use of Clostridium
butyricum and HMPA.
[Method] A randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted toevaluate the effects of foods containing Clostridium butyricum and HMPA on reducing body weight and body fat(visceral and subcutaneous fat ) . In addition, subjective evaluation and physical examination including blood
glucose level were performed as secondary outcomes.
Subjects were healthy men and women aged 20-59 years with a BMI of 23 or more and less than 30. A test productintake group of 16 subjects (6 men, 10 women) and a placebo group of 14 subjects (8 men, 6 women) were set. Inorder to confirm the effect of reducing body fat (visceral fat and subcutaneous fat), the test product intake group
took Clostridium butyricum 14.0 mg/day (14 million pieces/day) and HMPA 11.5 mg/day continuously for 12weeks. Maenwhile the placebo group did not receive the component. Outcomes were weight, BMI, body fat(visceral fat, subcutaneous fat), waist circumference, body fat percentage, etc., and were conducted in a randomized,
double-blind, placebo-controlled, parallel-group comparison study . We also checked for side effects during thetrial period. This test was conducted by the submitter after requesting and providing funding to an external testing
institution.
[Main results] After 12 weeks of intake, significant differences were observed in body weight, BMI, body fat(visceral fat, subcutaneous fat), waist circumference, and body fat percentage in the test product group comparedto the placebo group. In addition, subjective evaluation showed a significant improvement in body lightness and asignificant trend in clothes size. There were no issues with safety.