A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia
A randomized, double-blind, placebo-controlled trial was designed to assess the efficacy of the parabiotic <i>Bifidobacterium breve</i> IDCC 4401, named BBR 4401, for lowering cholesterol levels. The 66 subjects (per protocol set, n = 60) with low-density lipoprotein-cholesterol (LDL-C)...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-08-01
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| Series: | Fermentation |
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| Online Access: | https://www.mdpi.com/2311-5637/9/8/766 |
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| author | Mincheol Kim Minjee Lee Min-Goo Kim Hayoung Kim Boyoung Choi Seongsik Kim Won-Yeong Bang Yong-Jin Kim Jungwoo Yang Hyun-Jae Kang |
| author_facet | Mincheol Kim Minjee Lee Min-Goo Kim Hayoung Kim Boyoung Choi Seongsik Kim Won-Yeong Bang Yong-Jin Kim Jungwoo Yang Hyun-Jae Kang |
| author_sort | Mincheol Kim |
| collection | DOAJ |
| description | A randomized, double-blind, placebo-controlled trial was designed to assess the efficacy of the parabiotic <i>Bifidobacterium breve</i> IDCC 4401, named BBR 4401, for lowering cholesterol levels. The 66 subjects (per protocol set, n = 60) with low-density lipoprotein-cholesterol (LDL-C) levels between 100 mg/dL and 150 mg/dL were enrolled after a 4-week run-in period (e.g., no probiotics, low cholesterol diet and no food affecting lipid profiles). The two groups were prescribed 1 × 10<sup>10</sup> (low-dose) and 1 × 10<sup>11</sup> CFU (high-dose), whereas the placebo group was prescribed 97% (<i>w</i>/<i>w</i>) of maltodextrin for 4 weeks. The compliance rates exceeded 97% in the subjects who completed the study. Comparison of the mean changes from baseline between the placebo group and test groups after the 12 weeks of BBR 4401 consumption showed a statistically significant reduction in LDL-C (up to −10.8%, <i>p</i>-value = 0.008) and apolipoproteinB (up to −8.1%, <i>p</i>-value = 0.008). Meanwhile, there were no clinically significant changes in vital signs, clinical pathology tests or electrocardiograms and no significant adverse events were reported during the study period. Concerning bowel habits, the consumption of BBR 4401 alleviated defecation strain, distension and watery feces in the high-dose group. Thus, BBR 4401 may be a safe and functional food for adults with moderate hypercholesterolemia. |
| first_indexed | 2024-03-10T23:56:55Z |
| format | Article |
| id | doaj.art-13286203805e4e30851092a5d0723e2c |
| institution | Directory Open Access Journal |
| issn | 2311-5637 |
| language | English |
| last_indexed | 2024-03-10T23:56:55Z |
| publishDate | 2023-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Fermentation |
| spelling | doaj.art-13286203805e4e30851092a5d0723e2c2023-11-19T01:02:34ZengMDPI AGFermentation2311-56372023-08-019876610.3390/fermentation9080766A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate HypercholesterolemiaMincheol Kim0Minjee Lee1Min-Goo Kim2Hayoung Kim3Boyoung Choi4Seongsik Kim5Won-Yeong Bang6Yong-Jin Kim7Jungwoo Yang8Hyun-Jae Kang9Ildong Pharmaceutical, Hwaseong-si 18849, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaIldong Pharmaceutical, Hwaseong-si 18849, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 03080, Republic of KoreaIldong Bioscience, Pyeongtaek-si 17957, Republic of KoreaDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 03080, Republic of KoreaA randomized, double-blind, placebo-controlled trial was designed to assess the efficacy of the parabiotic <i>Bifidobacterium breve</i> IDCC 4401, named BBR 4401, for lowering cholesterol levels. The 66 subjects (per protocol set, n = 60) with low-density lipoprotein-cholesterol (LDL-C) levels between 100 mg/dL and 150 mg/dL were enrolled after a 4-week run-in period (e.g., no probiotics, low cholesterol diet and no food affecting lipid profiles). The two groups were prescribed 1 × 10<sup>10</sup> (low-dose) and 1 × 10<sup>11</sup> CFU (high-dose), whereas the placebo group was prescribed 97% (<i>w</i>/<i>w</i>) of maltodextrin for 4 weeks. The compliance rates exceeded 97% in the subjects who completed the study. Comparison of the mean changes from baseline between the placebo group and test groups after the 12 weeks of BBR 4401 consumption showed a statistically significant reduction in LDL-C (up to −10.8%, <i>p</i>-value = 0.008) and apolipoproteinB (up to −8.1%, <i>p</i>-value = 0.008). Meanwhile, there were no clinically significant changes in vital signs, clinical pathology tests or electrocardiograms and no significant adverse events were reported during the study period. Concerning bowel habits, the consumption of BBR 4401 alleviated defecation strain, distension and watery feces in the high-dose group. Thus, BBR 4401 may be a safe and functional food for adults with moderate hypercholesterolemia.https://www.mdpi.com/2311-5637/9/8/766<i>Bifidobacterium breve</i>probioticsparabioticscholesterolbile acidhypercholesterolemia |
| spellingShingle | Mincheol Kim Minjee Lee Min-Goo Kim Hayoung Kim Boyoung Choi Seongsik Kim Won-Yeong Bang Yong-Jin Kim Jungwoo Yang Hyun-Jae Kang A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia Fermentation <i>Bifidobacterium breve</i> probiotics parabiotics cholesterol bile acid hypercholesterolemia |
| title | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia |
| title_full | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia |
| title_fullStr | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia |
| title_full_unstemmed | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia |
| title_short | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia |
| title_sort | randomized double blind placebo controlled trial to evaluate the cholesterol lowering effect of bbr 4401 in adults with moderate hypercholesterolemia |
| topic | <i>Bifidobacterium breve</i> probiotics parabiotics cholesterol bile acid hypercholesterolemia |
| url | https://www.mdpi.com/2311-5637/9/8/766 |
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