Body Fat Reduction Effect of Bifidobacterium breve B-3: A Randomized, Double-Blind, Placebo Comparative Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Intervention
2.3. Randomization and Blinding
2.4. Endpoints
2.5. Safety
2.6. Sample Size Calculation
2.7. Statistical Analyses
3. Results
3.1. Participant Characteristics
3.2. Study Endpoints
3.3. Safety
3.4. Physical Activity and Diet
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Inclusion Criteria |
(1) Age 19–60 years |
(2) Body mass index (BMI) of ≥25 kg/m2 and <30 kg/m2 |
(3) Able to provide written informed consent |
Exclusion Criteria |
(1) Severe cerebrovascular disease (cerebral infarction and cerebral hemorrhage), heart disease (angina pectoris, myocardial infarction, heart failure, and arrhythmia requiring treatment), or malignant tumor within the last six months. However, participants with a medical history of cerebrovascular disease or heart disease who were clinically stable could participate in the trial at the investigator’s discretion |
(2) Taking drugs that affected body weight (fat absorption inhibitors and appetite suppressants, health food/supplements related to obesity, psychiatric drugs such as depression, beta-blockers, diuretics, contraceptives, steroids, and female hormones) within the last month |
(3) Obese or overweight due to endocrine diseases such as hypothyroidism and Cushing’s syndrome |
(4) Maintenance treatment for gastrointestinal disorders (gastric ulcer, chronic digestive disorder, and irritable bowel syndrome) |
(5) Psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, and bulimia) or a history of alcohol and other drug abuse |
(6) Judgment of inability to exercise due to musculoskeletal disorders |
(7) Fasting blood sugar of ≥126 mg/dL, random blood sugar of ≥200 mg/dL, or patients with diabetes taking oral hypoglycemic agents or insulin |
(8) Uncontrolled hypertension (blood pressure >160/100 mmHg measured after a 10-min rest) |
(9) Alanine aminotransferase(AST) or Alkaline phosphatase(ALT) level at least 2.5 times higher than the laboratory’s upper limit of normal |
(10) Creatinine levels more than twice the upper limit of normal in the testing institute |
(11) Weight loss ≥5% within the last three months |
(12) Participation in a commercial obesity program within the last three months |
(13) Participation in an obesity clinical trial within the last six months |
(14) Pregnancy, lactation, or was planning to become pregnant during the study period |
(15) An allergic reaction to the food study drug |
(16) Others were considered unsuitable for the study at the discretion of the principal investigator |
(17) The intake of probiotics within the last month |
BB-3 Group (n = 42) | Placebo Group (n = 41) | p-Value | ||
---|---|---|---|---|
Sex | Male | 15 (35.71) | 11 (26.83) | 0.3829 1 |
Female | 27 (64.29) | 30 (73.17) | ||
Age, years | 46.55 ± 9.76 | 45.02 ± 9.23 | 0.3361 2 | |
Height, cm | 164.17 ± 9.15 | 162.22 ± 8.87 | 0.3343 2 | |
Weight, kg | 72.71 ± 8.22 | 70.82 ± 8.17 | 0.2948 3 | |
Body mass index | 26.93 ± 1.29 | 26.85 ± 1.38 | 0.7325 2 | |
Waist circumference, cm | 88.39 ± 4.58 | 87.62 ± 5.55 | 0.4928 3 | |
Hip circumference, cm | 99.04 ± 3.66 | 98.60 ± 3.89 | 0.6003 3 | |
Fat mass index, g | 25,446.90 ± 4405.20 | 26,163.00 ± 3809.42 | 0.4311 3 | |
Fat-free mass index, g | 47,094.50 ± 8707.45 | 44,334.07 ± 8532.53 | 0.0965 2 | |
Family history of obesity | Yes No | 16 (38.10) 26 (61.90) | 16 (39.02) 25 (60.98) | 0.9307 1 |
BB-3 Group (n = 42) | Placebo Group (n = 41) | ||
---|---|---|---|
Body fat mass, g | V2 | 25,446.90 ± 4405.20 | 26,163.00 ± 3809.42 |
V5 | 24,859.86 ± 4382.83 | 26,098.63 ± 4022.56 | |
V5-V2 | −587.05 ± 1004.42 | −64.37 ± 933.76 | |
p-value | 0.0005 1 | 0.6613 1 | |
Difference V5-V2 (Tx-Px) | −522.68 ± 970.17 | ||
LS mean difference 5 | −528.56 | ||
p-value | 0.0170 3 | ||
Body fat percentage (%) | V2 | 36.60 ± 6.67 | 38.73 ± 6.14 |
V5 | 36.28 ± 6.77 | 38.64 ± 6.25 | |
V5-V2 | −0.32 ± 1.26 | −0.09 ± 0.97 | |
p-value | 0.1097 1 | 0.5431 1 | |
Difference V5-V2 (Tx-Px) | −0.22 ± 1.12 | ||
LS mean difference 5 | −0.23 | ||
p-value | 0.3760 3 | ||
Fat-free mass, g | V2 | 47,094.50 ± 8707.45 | 44,334.07 ± 8532.53 |
V5 | 46,622.79 ± 8539.42 | 44,362.80 ± 8454.12 | |
V5-V2 | −471.71 ± 1500.65 | 28.73 ± 840.49 | |
p-value | 0.0916 2 | 0.8279 1 | |
Difference V5-V2 (Tx-Px) | −500.45 ± 1220.14 | ||
p-value | 0.1172 4 |
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Sung, H.K.; Youn, S.J.; Choi, Y.; Eun, S.W.; Shin, S.M. Body Fat Reduction Effect of Bifidobacterium breve B-3: A Randomized, Double-Blind, Placebo Comparative Clinical Trial. Nutrients 2023, 15, 28. https://doi.org/10.3390/nu15010028
Sung HK, Youn SJ, Choi Y, Eun SW, Shin SM. Body Fat Reduction Effect of Bifidobacterium breve B-3: A Randomized, Double-Blind, Placebo Comparative Clinical Trial. Nutrients. 2023; 15(1):28. https://doi.org/10.3390/nu15010028
Chicago/Turabian StyleSung, Hyun Kyung, Sang Jun Youn, Yong Choi, Sang Won Eun, and Seon Mi Shin. 2023. "Body Fat Reduction Effect of Bifidobacterium breve B-3: A Randomized, Double-Blind, Placebo Comparative Clinical Trial" Nutrients 15, no. 1: 28. https://doi.org/10.3390/nu15010028
APA StyleSung, H. K., Youn, S. J., Choi, Y., Eun, S. W., & Shin, S. M. (2023). Body Fat Reduction Effect of Bifidobacterium breve B-3: A Randomized, Double-Blind, Placebo Comparative Clinical Trial. Nutrients, 15(1), 28. https://doi.org/10.3390/nu15010028