Effect of Continuous Ingestion of Bifidobacteria and Inulin on Reducing Body Fat: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Test Foods
2.3. Experimental Design
2.4. Abdominal Fat Area
2.5. Anthropometric Measures and Body Composition
2.6. Clinical Parameters
2.7. Fecal Samples
2.8. Fecal DNA Extraction
2.9. Fecal Bifidobacteria
2.10. Statistical Analysis
3. Results
3.1. Analysis of the Participant Population
3.2. Abdominal Fat Area
3.3. Anthropometric Parameters
3.4. Biochemical Parameters in Plasma
3.5. Fecal Bifidobacteria
3.6. Regression Analysis with Fecal Bifidobacteria and Measured Parameters
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Parameter | Placebo Group | Active Group |
---|---|---|
Energy, kcal/100 g | 47.0 | 52.0 |
Moisture, g/100 g | 87.0 | 84.8 |
Protein, g/100 g | 2.8 | 2.8 |
Fat, g/100 g | 0.1 | 0.1 |
Carbohydrate, g/100 g | 9.0 | 11.2 |
Ash, g/100 g | 1.1 | 1.1 |
Characteristic | Placebo Group | Active Group | p-Value | |
---|---|---|---|---|
Clinical findings | Age, years | 50.6 (8.0) | 50.6 (8.4) | 0.973 |
Height, cm | 165.9 (8.2) | 167.8 (8.5) | 0.221 | |
Body weight, kg | 73.6 (7.9) | 73.8 (8.2) | 0.873 | |
Body mass index, kg/m2 | 26.7 (1.5) | 26.2 (2.0) | 0.129 | |
Waist circumference, cm | 92.5 (5.1) | 92.4 (6.2) | 0.902 | |
Hip circumference, cm | 98.0 (3.6) | 98.2 (4.5) | 0.840 | |
Waist-to-hip ratio | 0.9 (0.04) | 0.9 (0.04) | 0.720 | |
Visceral fat area, cm2 | 124.9 (31.0) | 124.0 (31.3) | 0.864 | |
Subcutaneous fat area, cm2 | 206.0 (58.1) | 207.7 (65.2) | 0.881 | |
Total fat area, cm2 | 330.9 (61.6) | 331.7 (69.8) | 0.953 | |
Systolic blood pressure, mmHg | 127.7 (11.2) | 132.4 (15.1) | 0.055 | |
Diastolic blood pressure, mmHg | 79.0 (10.6) | 82.3 (11.7) | 0.108 | |
Heartbeat, bpm | 77.5 (10.5) | 78.4 (10.8) | 0.644 | |
Laboratory findings | White blood cell count, /µL | 6185.0 (1449) | 6076.7 (1077) | 0.643 |
Red blood cell count, ×104/µL | 495.8 (45.4) | 489.0 (43.8) | 0.405 | |
Hemoglobin, g/dL | 15.0 (1.3) | 14.7 (1.2) | 0.214 | |
Hematocrit, % | 47.2 (3.6) | 46.6 (3.2) | 0.351 | |
Platelet count, ×104/μL | 26.7 (4.5) | 28.0 (6.0) | 0.164 | |
Neutrophil ratio, % | 58.3 (7.2) | 57.8 (5.9) | 0.675 | |
Lymphocyte ratio, % | 32.2 (6.8) | 32.6 (5.7) | 0.678 | |
Monocyte ratio, % | 5.6 (1.3) | 5.3 (1.0) | 0.193 | |
Eosinophil ratio, % | 3.2 (2.0) | 3.4 (2.7) | 0.652 | |
Basophil ratio, % | 0.7 (0.3) | 0.9 (0.3) | 0.047 | |
Total serum protein, g/dL | 7.2 (0.4) | 7.3 (0.3) | 0.237 | |
Albumin, g/dL | 4.4 (0.3) | 4.5 (0.3) | 0.120 | |
Aspartate aminotransferase, U/L | 24.8 (10.8) | 23.5 (6.7) | 0.430 | |
Alanine aminotransferase, U/L | 30.4 (21.2) | 26.6 (17.1) | 0.280 | |
Lactate dehydrogenase, U/L | 183.0 (29.6) | 188.9 (32.7) | 0.308 | |
Total bilirubin, mg/dL | 0.8 (0.2) | 0.9 (0.3) | 0.228 | |
Alkaline phosphatase, U/L | 75.7 (19.9) | 76.8 (17.3) | 0.758 | |
Laboratory findings | γ-Glutamyl transpeptidase, U/L | 40.4 (31.3) | 44.7 (36.6) | 0.485 |
Blood urea nitrogen, mg/dL | 13.3 (2.8) | 13.8 (3.2) | 0.356 | |
Creatinine, mg/dL | 0.8 (0.15) | 0.8 (0.16) | 0.894 | |
Uric acid, mg/dL | 5.8 (1.3) | 5.8 (1.3) | 0.746 | |
Sodium (Na), mEq/L | 141.3 (1.7) | 141.4 (1.4) | 0.726 | |
Chlorine (Cl), mEq/L | 104.1 (2.2) | 103.9 (1.7) | 0.645 | |
Potassium (K), mEq/L | 4.2 (0.3) | 4.2 (0.2) | 0.145 | |
Calcium (Ca), mg/dL | 9.5 (0.3) | 9.5 (0.3) | 0.294 | |
Total cholesterol, mg/dL | 218.0 (30.2) | 217.8 (31.9) | 0.967 | |
LDL cholesterol, mg/dL | 140.0 (27.5) | 137.9 (30.0) | 0.694 | |
HDL cholesterol, mg/dL | 55.3 (12.4) | 58.6 (14.7) | 0.185 | |
Triglycerides, mg/dL | 131.6 (65.8) | 121.4 (49.7) | 0.338 | |
Glucose, mg/dL | 89.8 (9.2) | 89.1 (9.6) | 0.677 | |
HbA1c (NGSP), % | 5.5 (0.3) | 5.5 (0.3) | 0.926 | |
Free fatty acid, mEq/L | 0.4 (0.2) | 0.5 (0.2) | 0.077 | |
Urine pH | 6.2 (0.5) | 6.2 (0.6) | 0.560 | |
Urine specific gravity | 1.0 (0.007) | 1.0 (0.007) | 0.491 | |
Compliance rate of the test sample, % * | 99.80 (0.50) | 99.88(0.42) | 0.349 |
Parameter | 0 Weeks | 4 Weeks | 8 Weeks | 12 Weeks | |
---|---|---|---|---|---|
Energy, kcal | Active | 1820.9 (385.4) | 1816.5 (428.4) | 1792.3 (399.5) | 1704.8 (413.2) * |
Placebo | 1925.3 (360.3) | 1929.8 (411.4) | 1880.7 (414.8) | 1820.1 (366.6) * | |
Protein, g | Active | 68.7 (15.7) | 67.3 (17.8) | 66.0 (16.2) | 64.9 (17.5) * |
Placebo | 72.5 (15.3) | 72.1 (15.4) | 69.7 (19.0) | 68.6 (14.9) * | |
Fat, g | Active | 63.8 (17.9) | 61.4 (19.2) | 60.7 (20.0) | 55.9 (19.1) *# |
Placebo | 67.9 (20.0) | 66.9 (20.4) | 65.3 (20.6) | 64.1 (18.7) | |
Carbohydrate, g | Active | 229.7 (53.0) | 236.2 (57.4) | 233.3 (52.8) | 222.6 (54.8) |
Placebo | 243.3 (56.2) | 247.1 (59.4) | 240.4 (53.5) | 230.2 (50.6) * | |
Dietary fiber, g | Active | 10.8 (3.3) | 10.7 (3.1) | 10.6 (3.1) | 10.1 (3.2) |
Placebo | 10.9 (2.9) | 11.0 (3.0) | 10.4 (3.0) | 9.9 (2.7) * |
Parameter | 0 Weeks | 8 Weeks | 12 Weeks | Time × Group † | |
---|---|---|---|---|---|
Visceral fat area, cm2 | Active | 124.0 (4.1) | 111.1 (4.2) * | 106.8 (3.6) * | <0.0001 |
Placebo | 119.8 (3.9) | 117.5 (4.9) | 114.9 (4.0) | ||
Subcutaneous fat area, cm2 | Active | 206.9 (8.3) | 207.2 (8.3) | 206.7 (8.6) | 0.379 |
Placebo | 211.9 (8.8) | 212.2 (8.6) | 215.8 (9.4) | ||
Total fat area, cm2 | Active | 331.0 (9.3) | 318.4 (9.9) * | 313.5 (9.5) * | 0.001 |
Placebo | 331.7 (9.1) | 329.7 (10.2) | 330.7 (10.3) |
Parameter | 0 Weeks | 4 Weeks | 8 Weeks | 12 Weeks | |
---|---|---|---|---|---|
Body weight, kg | Active | 74.9 (1.1) | 74.8 (1.1) | 74.7 (1.1) | 74.6 (1.1) * |
Placebo | 74.8 (1.1) | 74.8 (1.1) | 74.6 (1.1) | 74.3 (1.1) | |
Body mass index, kg/m2 | Active | 26.5 (0.3) | 26.4 (0.3) | 26.4 (0.3) | 26.3 (0.3) * |
Placebo | 27.0 (0.2) | 27.0 (0.2) | 26.9 (0.2) | 26.9 (0.2) | |
Waist-to-hip ratio | Active | 0.9 (0.005) | 0.9 (0.005) | 0.9 (0.005) | 0.9 (0.005) |
Placebo | 0.9 (0.006) | 0.9 (0.005) | 0.9 (0.005) | 0.9 (0.005) |
Parameter | 0 Weeks | 4 Weeks | 8 Weeks | 12 Weeks | |
---|---|---|---|---|---|
Total cholesterol, mg/dL | Active | 219.4 (4.2) | 217.6 (4.1) | 211.6 (4.2) * | 217.5 (4.6) |
Placebo | 219.2 (4.2) | 219.0 (3.7) | 216.2 (4.2) | 219.4 (4.3) | |
LDL cholesterol, mg/dL | Active | 139.9 (4.2) | 136.3 (3.8) | 135.3 (3.9) * | 136.5 (4.3) |
Placebo | 136.3 (3.8) | 139.0 (3.4) | 138.7 (3.7) | 138.1 (4.0) | |
HDL cholesterol, mg/dL | Active | 57.9 (2.1) | 59.0 (1.9) | 55.8 (1.7) * | 56.2 (1.7) |
Placebo | 55.5 (1.7) | 54.6 (1.8) | 54.2 (1.9) | 54.5 (1.8) | |
Triglycerides, mg/dL | Active | 113.6 (7.0) | 116.2 (6.3) # | 113.6 (5.4) # | 118.3 (8.8) |
Placebo | 130.2 (8.3) | 141.7 (11.1) | 138.5 (10.1) | 143.1 (15.8) | |
Free fatty acid, mEq/L | Active | 0.53 (0.03) | 0.50 (0.02) | 0.53 (0.02) | 0.61 (0.03) * |
Placebo | 0.48 (0.03) | 0.50 (0.02) | 0.48 (0.02) | 0.55 (0.03) * |
Bifidobacteria | 0 Weeks | 8 Weeks | 12 Weeks | |
---|---|---|---|---|
Total bifidobacteria | Active | 9.62 (0.14) | 10.35 (0.08) *# | 10.41 (0.07) *# |
Placebo | 9.48 (0.17) | 9.60 (0.17) | 9.61 (0.17) | |
B. animalis subsp. lactis | Active | 5.70 (0.15) | 9.67 (0.09) *# | 9.77 (0.08) *# |
Placebo | 5.70 (0.14) | 5.72 (0.15) | 5.50 (0.10) | |
B. longum subsp. longum | Active | 8.62 (0.20) | 8.86 (0.23) * | 8.96 (0.23) * |
Placebo | 8.26 (0.23) | 8.35 (0.24) | 8.37 (0.23) | |
B. adolescentis group | Active | 7.81 (0.28) | 8.14 (0.31) * | 8.18 (0.31) * |
Placebo | 7.73 (0.29) | 8.09 (0.29) | 8.19 (0.30) | |
B. catenulatum and B. pseudocatenulatum | Active | 8.22 (0.25) | 8.40 (0.27) *# | 8.37 (0.27) *# |
Placebo | 7.89 (0.26) | 7.87 (0.26) | 7.90 (0.25) | |
B. breve | Active | 5.66 (0.11) | 5.77 (0.12) | 5.74 (0.12) |
Placebo | 5.62 (0.11) | 5.62 (0.11) | 5.68 (0.12) | |
B. bifidum | Active | 6.02 (0.20) | 6.08 (0.20) | 6.14 (0.21) |
Placebo | 5.89 (0.18) | 5.98 (0.19) | 5.98 (0.19) | |
B. longum subsp. infantis | Active | 5.53 (0.09) | 5.59 (0.11) | 5.57 (0.10) |
Placebo | 5.51 (0.09) | 5.51 (0.10) | 5.52 (0.09) | |
B. dentium | Active | 5.64 (0.11) | 5.66 (0.10) | 5.63 (0.10) |
Placebo | 5.63 (0.09) | 5.71 (0.10) | 5.64 (0.09) | |
B. angulatum | Active | n.d. | n.d. | n.d. |
Placebo | n.d. | n.d. | n.d. | |
Endogenous bifidobacteria | Active | 9.60 (0.14) | 9.89 (0.16) * | 9.92 (0.16) * |
Placebo | 9.45 (0.17) | 9.57 (0.17) | 9.61 (0.17) |
Object Variable | Ratio of Change from Week 0 to 12 | Explanatory Variable | Change from Week 0 to 12, % | p-Value |
---|---|---|---|---|
Total bifidobacteria | 33.46 (12.51) | BMI | −0.5 (0.2) | 0.010 |
VFA | −7.2 (1.3) | 0.012 | ||
Endogenous bifidobacteria | 27,875.92 (5977.64) | BMI | −0.5 (0.2) | 0.025 |
B. animalis subsp. lactis | 8.07 (2.63) | BMI | −0.5 (0.2) | 0.025 |
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Baba, Y.; Saito, Y.; Kadowaki, M.; Azuma, N.; Tsuge, D. Effect of Continuous Ingestion of Bifidobacteria and Inulin on Reducing Body Fat: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study. Nutrients 2023, 15, 5025. https://doi.org/10.3390/nu15245025
Baba Y, Saito Y, Kadowaki M, Azuma N, Tsuge D. Effect of Continuous Ingestion of Bifidobacteria and Inulin on Reducing Body Fat: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study. Nutrients. 2023; 15(24):5025. https://doi.org/10.3390/nu15245025
Chicago/Turabian StyleBaba, Yuhei, Yasuo Saito, Mei Kadowaki, Naoki Azuma, and Daisuke Tsuge. 2023. "Effect of Continuous Ingestion of Bifidobacteria and Inulin on Reducing Body Fat: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study" Nutrients 15, no. 24: 5025. https://doi.org/10.3390/nu15245025