Human Clinical Studies
on Fermented Vegetable Extract OM-X
“OM-X” is a fermented vegetable extract that combines dozens of different kinds of plants fermented with a mixture of 12 kinds of probiotic strains including E. faecalis TH10. We performed many human clinical studies not only in Japan, but also in foreign countries. The data from the studies have gained worldwide recognition.
Improvement of the Balance of Bacteria Responsible for Gaining or Losing Weight
Collaborative research with Hokkaido University of Science (2018)
The intake of OM-X capsules improved the balance of bacteria responsible for gaining or losing weight in the intestines of healthy people.
Objective
We examined whether the capsules filled with OM-X extract (OM-X capsules) can improve the balance of gut microbiota in healthy people who tend to be constipated.
Methods
The test subjects were twenty healthy male and female who tend to be constipated and were divided into two groups: taking placebo or OM-X capsules three times a day. After 10 days of ingestion, one month of non administration period was set. Then, a complete cross-over of OM-X or placebo materials were provided to the subjects. Their fecal matter was collected before and after the test material ingestion. The analysis of their gut microbiota was conducted on the fecal matter.
Results
Many research papers have suggested that there are increased bacteria from the phylum Firmicutes and decreased numbers from the phylum Bacteroidetes in the intestines of obese people. The phylum Firmicutes is often considered as the bacteria responsible for weight gain. Through this experiment, the number of phylum Bacteroidetes was significantly increased and the phylum Firmicutes was significantly reduced after ingesting OM-X. Based on these results, OM-X can improve the balance of gut microbiota
Increase of VO2 max
Journal of Appleid Nutrition 53, 1-6 (2003)
The OM-X capsule is effective in increasing the level of maximal oxygen consumption (VO2 max).
Objective
We examined the influence of the maximal oxygen consumption (VO2 max: an index which shows the maximum oxygen consumption capacity per minute of a person) after taking the OM-X capsules.
Methods
The study subjects were six adult male athletes. We measured their VO2 max before taking the OM-X capsules. The subjects took the OM-X capsules every day for two weeks. After the ingestion periods were concluded, we measured their VO2 max, hemoglobin levels in blood and blood lactate levels. Subsequently, we evaluated the effect of the OM-X capsules toward VO2 max by comparing it with the levels that were measured before starting the ingestion.
Results
The intake of the OM-X capsules for 2 weeks increased the VO2 max of the six adult male subjects being tested. The increment of VO2 max was by an average of 30% per weight.
There was not much change in the blood lactate levels and the hemoglobin levels in blood increased approximately 8.4 % after the intake of the OM-X capsules.
This study has revealed that the OM-X capsules can increase the VO2 max of athletes.
Constipation Improvement
The 69th Annual Meeting of Japan Society of Nutrition and Food Science (2015)
The OM-X capsule is effective in reducing constipation and improving the stool condition among female college students having a tendency toward constipation.
Objective
We evaluated the influence on bowel movement and the properties of stools by the intake of an encapsulated OM-X extract (OM-X capsule) among female college students having a tendency to be constipated.
Methods
The subjects for the study were selected from 54 female college students with either a normal bowel movement or a tendency toward constipation. We examined the habits of bowel movement of each subject for 2 weeks before, during and after taking the OM-X capsules. The statistics on both groups were reviewed along the test items of defecation frequency, stool output, color, form, smell, and relief the subjects feel.
Results
The female college students having a tendency to be constipated showed a significant increase in defecation frequency and stool output in comparison with their conditions before taking the OM-X capsules. According to the other index of stool including color, form, smell, and relief the subjects feel, the frequency of stools with the ideal conditions also increased during the intake periods.
These results suggested that an intake of the OM-X capsules help to relieve constipation for people who tend to
experience hard bowel movements.
Allevation of Pneumonia
3rd Asian Congress of Pediatric Infectious Diseases and 13th Pediatric Infectious Disease Society of The Philippines Annual Convention (2006)
The OM-X capsule is effective in reducing the length of hospital stay of infants with pneumonia.
Objective
We examined the improvements of pneumonia symptoms by ingestion of OM-X capsules among infants with severe pneumonia.
Methods
The test subjects were 76 infants between 6-24 months old with severe pneumonia at the hospital in the Philippines. We divided the infants into a group that was administrated only antibiotics and a group with OM-X + antibiotic (low amount). Then, we compared the subject groups with respect to the average number of days taken until the alleviation of coughing and fever, which are an index of the pneumonia symptoms. We cut a capsule and gave its contents to the infants who could not swallow the OM-X capsule.
Results
In the OM-X + antibiotic (low amount) group, the average number of days taken until alleviation of coughing was remarkably reduced compared to the other group. The average number of days taken until alleviation of fever also became shorter in the OM-X + antibiotic (low amount) group. These results showed that the OM-X capsule is effective in reducing and improving pneumonia symptoms, and possibly contributing to diminish the use of antibiotics.
Improvement in Diarrhea
1st Congress of Asian Society for Pediatric Research (2005)
The OM-X capsule is effective in reducing diarrheal symptoms among infants.
Objective
We examined about improvement in diarrheal symptoms by ingestion of the OM-X capsules among infants with acute non-bloody diarrhea.
Methods
The test subjects were 70 infants between 3-24 months of age with acute non-bloody diarrhea at the hospital in the Philippines. We divided infants into the OM-X administered group and the OM-X non-administration group. Then, we compared subject groups with respect to the following range of items: the number of days with diarrhea, the frequency of defecation per day and the degree of weight restoration during episodes of diarrhea. We cut a capsule and gave its contents to the infants who could not swallow the OM-X capsule.
Results
The infants in the OM-X administered group showed a shortened duration of diarrhea (the average number of days for stool to be formed). The frequency of daily defecation of the infants in the OM-X administered group decreased in comparison with the group without the OM-X capsules.
Furthermore, the group that was administered the OM-X capsules recovered significantly from the weight loss caused by diarrhea. These results showed that the OM-X capsules are effective for improving diarrheal symptoms.
Increase in Bone Density
Kurashiki University of Science and the Arts. 3, 131-144 (1998)
The OM-X capsule is effective in an increment of bone density among adult males and females.
Objective
We examined an increment of bone density by ingestion of the OM-X capsules in healthy adult males and females.
Methods
We divided test subjects into two groups: a group with an intake of the OM-X capsules and the other without the OM-X capsules. After a certain period of time, we measured the bone densities of subjects in each group. The bone density measurements were analyzed based on the volume of bone mineral content in the humerus and ulna at the test subjectsʼ non-dominant hand, bone mass, and the ratio of bone areas and bone mass.
Results
Overall, male subjects in the group given the OM-X capsules showed about 20% higher scores in bone density compared to those without the OM-X capsules. Female subjects with the OM-X capsules showed 12% higher scores than those without the OM-X capsules. The same tendency was observed in every aging group.
In the aspect of bone areas, the group with the OM-X capsule also showed higher values.
These results suggested that an intake of the OM-X capsules is effective in an increment of bone density and bone area regardless of age or gender.
Alleviation of Dengue Fever
Asian Conference on Dirrhoeal Diseases and Nutrition (2006)
The OM-X capsule is effective in reducing symptoms of dengue hemorrhagic fever.
Objective
We examined the improvements of dengue hemorrhagic fever symptoms among child patients ingesting OM-X capsules.
Methods
The test subjects were 36 patients between 4-18 years old with symptoms of dengue hemorrhagic fever (grade I and II) at the hospital in the Philippines. We divided the patients into the OM-X administered group and the placebo group. Then, we compared the subject groups with following index: recovery from the fever, restoration of appetite, abdominal pain, bleeding, blood cell count and platelet count.
Results
The number of days taken until fever abatement was significantly shortened in the group with OM-X capsule compared to the placebo group. The number of days taken until restoration of appetite was also significantly shortened.
These results showed that an intake of the OM-X capsule during an infectious episode of dengue hemorrhagic fever hastened recovery from the febrile symptoms and loss of appetite.
The blood cell counts tended to increase at an early point in the group with OM-X capsule compared to the placebo group.
Improvement in Urinary Tract Infection
The OM-X capsule showed a preventive effect against urinary tract infection.
Objective
We compared the effect of the OM-X capsules and an antibiotic (nitrofurantoin) against recurrent urinary tract infection among children with urinary tract abnormalities.
Methods
The test subjects were 56 patients with urinary tract infection at the hospital in the Philippines. We divided the patients into a group that was administrated OM-X capsules and a group that was administrated antibiotic (nitrofurantoin). Then, we compared the subject groups regarding their potential level of to prevent a relapse of urinary tract infection.
Results
Regarding the potential to prevent a relapse of urinary tract infection among children with urinary tract abnormalities, the group that was administrated OM-X capsules showed a similar high defense rate against infection as the group that was administrated with the antibiotic. In late years, we are amid growing concerns over the emergence of drug-resistant strains of bacteria from overuse of antibiotics. The fact that the OM-X capsules showed the same effectiveness as antibiotics allow us to expect them to be an alternative to antibiotics.
Human Safety Test
The product safety at human level has been demonstrated through a collaborative research with Harvard University.
Objective
We conducted a collaborative research with Harvard University in the United States in order to demonstrate that the ingestion of OM-X capsules has no adverse effect on the human body.
Methods
At a hospital affiliated with Harvard University, 46 test subjects were divided into two groups: taking placebo or OM-X capsules. We confirmed whether there were abnormalities two weeks after the start of this test and when the test was completed (30 days later).
Results
No adverse effects were observed in blood biochemistry data or medical diagnoses in the group who ingested OM-X capsules. Based on these results, we demonstrated that the OM-X capsules do not adversely affect the human body and are a safe food when people take them on a daily basis.
Malnutrition Improvement
The OM-X capsule is effective in increasing the weight of malnourished children.
Objective
We examined the improvements in immune markers and symptoms of malnutrition by ingestion of the OM-X capsules among malnourished children.
Methods
The test subjects were 29 children with malnutrition at the hospital in the Philippines. We observed the OM-X capsules adinistrated malnourished children group with following index: immune markers, weights, incidence rate and duration of infection, and measured the effect of the OM-X capsules.
Results
The weight of malnourished children significantly increased in the group that was administrated OM-X capsules compared with the other group. The incidence rates of infection were the same level in both groups. However, the duration of infection was significantly shortened in the group with the OM-X capsules. This result suggested that an intake of the OM-X capsules contributed to improve the nutritional status of malnourished children.
Human Test For Overdose
A high level of safety was confirmed under the condition of ingesting an amount 5 times greater than the normal dosage.
Objective
We conducted a collaborative clinical study in order to demonstrate that there is no adverse effect on the human body even when people ingest a dosage five times greater (15 capsules) of OM-X capsules than the ordinary dosage (3 capsules) on a daily basis.
Methods
Ten test subjects ingested 15 OM-X capsules daily for one month. Their blood samples were collected before and after the ingestion period and blood biochemistry data was investigated.
Results
No adverse effects were observed in blood biochemistry data even in cases of an intake of 15 capsules. Based on this result, we confirmed that there was no adverse effect on the human body even when people ingest more OM-X capsules than the recommended dosage of 3 capsules per day.