Benefits
Visceral fat area in adults with a higher BMI
In 90 adults with a BMI of 25 to 35, 10 billion CFU a day for 12 weeks lowered CT visceral fat area more than placebo, a 21.6 cm2 difference (P = .012); the 1 billion CFU dose was not reported to differ. Waist size fell from baseline on both doses but not on placebo, and blood markers did not differ. The abstract names no main outcome; the registry entry, filed after enrollment began, lists three CT fat areas.
Body weight and waist size over 12 weeks
In 57 adults with a BMI of 23 or more and fasting glucose of at least 100 mg/dL, 10 billion CFU a day for 12 weeks did not change body weight compared with placebo, the stated main outcome. Weight fell about 1.1 kg and waist about 2 cm within the strain group only, and CT visceral fat, body fat percentage and blood lipids did not differ between groups.
Loose stools and abdominal pain ratings over 8 weeks
In 51 of 60 adults with diarrhea-predominant IBS analyzed after 8 weeks, 10 billion CFU a day improved diarrhea ratings in 67% versus 26% on placebo and lowered several quality-of-life scores such as abdominal pain and bloating. The stated main outcome was broad bowel function across many questionnaires, overall self-rated relief did not differ, and no correction was made for multiple tests.
Abdominal pain ratings at four daily doses
In a 4-week dose-finding trial in adults with a BMI over 23 and self-reported bowel symptoms, only the 10 billion CFU a day dose lowered abdominal pain scores more than placebo (P = 0.020, n = 10 versus 12); bloating and emptying scores improved in every group, placebo included. The registered main outcome was glucose tolerance, which was not reported, and 13 of 55 were not analyzed.
Strain recovery in stool after daily intake
In the 4-week dose-finding trial, a strain-specific test found BNR17 in stool from 7 of 9, 10 of 11 and 9 of 10 people on 200 million, 2 billion and 10 billion CFU a day, and in none of 12 on placebo. Total fecal lactobacilli rose most on the highest dose. This shows the strain passed through the gut alive.
Fasting blood sugar over 8 to 12 weeks
In the 8-week bowel trial, median fasting glucose fell from 101.5 to 97.5 mg/dL within the strain group, but the change did not differ from placebo (P = 0.307); HbA1c and insulin did not change. In the 12-week weight trial in adults with fasting glucose of at least 100 mg/dL, glucose and insulin did not differ between groups, and a 4-week trial registered with glucose tolerance as its main outcome never reported it.
Mechanism of action
Less weight and fat gain on sugar-rich diets in rodents (animal work)
In rats on a high-carbohydrate diet for 12 weeks and mice on a high-sucrose diet for 10 weeks, BNR17 limited weight and white fat gain, raised fat-burning gene activity and lowered leptin and insulin in mice. Bioneer scientists ran these studies, and the human weight trials found smaller or no changes.
Blood glucose in diabetic mice (animal work)
In db/db mice given BNR17 twice a day for 12 weeks, the highest dose lowered fasting and 2-hour blood glucose compared with untreated mice and improved glucose tolerance in a dose-dependent way, while body weight did not fall. Human trials have not shown a between-group effect on blood sugar.
Fecal exopolysaccharides and sugar transport genes in mice (animal work)
In mice on a high-sucrose diet, BNR17 raised fecal exopolysaccharides and tended to lower gut sugar transporter gene activity, which the authors read as reduced sugar absorption. All authors work for AceBiome, and this has not been measured in people.
Clinical trials
Randomized, double-blind, placebo-controlled trial; placebo, 1 billion (10^9) or 10 billion (10^10) CFU of BNR17 a day for 12 weeks, with CT abdominal fat areas, body composition and blood markers measured at the start and end; the abstract names no primary outcome, while the Korean registry entry KCT0000756 (registered about three weeks after enrollment began, sponsored and funded by Bioneer and the Ministry of Agriculture, Food and Rural Affairs) lists CT total, visceral and subcutaneous fat areas as primary; authors are at a contract research organization, Seoul National University Hospital and Ewha Womans University, none listed at Bioneer; full text not read (Kim et al. 2018, J Med Food)
90 Korean adults aged 20 to 75 with a BMI of 25 to 35, randomized to three groups.
Visceral fat area fell more on 10 billion CFU a day than on placebo (P = .038), and the 12-week difference versus placebo was -21.6 cm2 (P = .012); with two dose arms, only the P = .012 result clears a Bonferroni threshold of .025, and results for total and subcutaneous fat areas are not given in the abstract. Waist size fell from baseline on both doses (P = .045 and .012) but not on placebo. Blood markers did not differ among groups.
Single-center, randomized, double-blind, placebo-controlled trial; 10 billion (10^10) CFU of BNR17 a day as six capsules (two before each meal) with trehalose, skim milk and fructooligosaccharide filler, or filler-only capsules, for 12 weeks with no diet or exercise changes; the stated primary end point was the rate of weight reduction, and the trial was powered to detect a 2.5 kg difference; no registry number is reported; funded by Bioneer through a contract research organization, and three of seven authors work at Bioneer's R&D center (Jung et al. 2013, Korean J Fam Med)
62 Korean adults aged 19 to 60 with a BMI of 23 or more and fasting blood glucose of at least 100 mg/dL (31 per group); the paper reports 8 withdrawals (6 strain, 2 placebo) yet analyzes 57.
Body weight, the primary outcome, did not differ between groups at 12 weeks. Within the strain group, weight fell 1.1 kg, BMI 0.5 kg/m2 and waist 2 cm, but none of these differed from placebo, and CT visceral fat, body fat percentage, fasting glucose, insulin and blood lipids did not change between groups. No adverse reactions were judged related to the capsules; hematocrit changed in the strain group.
Single-center, randomized, double-blind, placebo-controlled trial (KCT0000969); four capsules a day providing 10 billion (10^10) CFU of BNR17 from Bioneer, or maltodextrin capsules, for 8 weeks; the stated primary end point was improvement of bowel function, measured with several questionnaires, a stool chart and colon transit time, analyzed per protocol without correction for multiple tests; the paper credits Korean government ministries and declares no conflicts, while the registry entry (filed December 31, 2013, after enrollment began December 6) also lists Bioneer Corporation as a funder and names a bowel function questionnaire as the primary outcome; no Bioneer authors are listed (Shin et al. 2018, J Clin Biochem Nutr)
60 Korean adults aged 20 to 55 with diarrhea-predominant IBS by Rome III criteria (30 per group); 51 analyzed (24 strain, 27 placebo).
Diarrhea ratings improved in 16 of 24 on the strain versus 7 of 27 on placebo (p < 0.01), and scores for abdominal pain, bloating, satisfaction with bowel movements and disruption of daily life fell more than on placebo (p < 0.05). Overall self-rated symptom improvement did not differ. Colon transit time lengthened within the strain group only; the authors state the between-group difference was not significant. Safety blood tests did not change.
Randomized, double-blind, placebo-controlled, dose-finding trial (KCT0000368) with a 7-day run-in; placebo (dextrin), 200 million, 2 billion or 10 billion CFU of BNR17 a day supplied by Bioneer for 4 weeks; symptom scores on a five-point scale and fecal strain detection were assessed, the paper states no primary outcome, but the registry entry (filed February 24, 2012, after enrollment began February 6, and titled as a glucose tolerance pilot study) lists the oral glucose tolerance test as primary and the bowel questionnaire as secondary, and no glucose tolerance results are reported; Dunnett's test was used for comparisons with placebo; the paper credits the National Research Foundation of Korea, while the registry also lists Bioneer as a funder; no Bioneer authors are listed (Kim et al. 2018, Food Sci Biotechnol)
55 Korean adults over 20 with a BMI over 23 and self-reported bowel symptoms (the registry also lists a 30-minute post-glucose-load blood glucose threshold of 140 mg/dL as an entry criterion); 42 analyzed (12 placebo, 9, 11 and 10 on the three doses).
Abdominal pain scores fell more than placebo on 10 billion CFU a day only (P = 0.020). Bloating and incomplete emptying improved from baseline in every group, placebo included, with no between-group difference reported. BNR17 was found in stool in 7 of 9, 10 of 11 and 9 of 10 on the three doses and in none on placebo. Adverse events were not reported.